xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05986370</url>
    </required_header>
    <id_info>
      <org_study_id>METRIC</org_study_id>
      <nct_id>NCT05986370</nct_id>
    </id_info>
    <brief_title>The METRIC Study Protocol</brief_title>
    <acronym>METRIC</acronym>
    <official_title>The METRIC Study Protocol: an Explanatory Randomized Controlled Trial Investigating the Neurophysiological Mechanisms Underlying the Therapeutic Effects of Spinal Manipulative Therapy for Chronic Primary Low Back Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Université du Québec à Trois-Rivières</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Université du Québec à Trois-Rivières</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to test the effects of spinal manipulative therapy in&#xD;
        individuals with chronic primary low back pain and determine the neurophysiological&#xD;
        mechanisms underlying pain relief. The main questions it aims to answer are: • Is pain relief&#xD;
        produced by spinal manipulative therapy in patients with chronic primary low back pain caused&#xD;
        by a reduction of C-fiber-related nociceptive processing? • Are these effects greater when&#xD;
        spinal manipulative therapy is applied to the whole spine where it is clinically indicated&#xD;
        compared with lumbar spine only? • Are these effects greater after 36 treatments over 3&#xD;
        months compared with 12 treatments over 1 month. Participants will receive spinal&#xD;
        manipulative therapy (all clinically indicated spine segments or back only) or a control&#xD;
        intervention. A group of healthy volunteers will be recruited to assess secondary outcome&#xD;
        measures over the same time period, as reference data for comparisons. Researchers will&#xD;
        compare the two groups receiving spinal manipulative therapy to the group receiving the&#xD;
        control intervention to see if clinical pain relief and the reduction of temporal summation&#xD;
        of second pain (produced experimentally) is significantly greater with spinal manipulative&#xD;
        therapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 29, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>low back pain intensity</measure>
      <time_frame>baseline, 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.</time_frame>
      <description>In accordance with recommendations for chronic pain trials, participants will be instructed to rate the intensity of their LBP using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). As in the brief pain inventory (BPI), they will be instructed to rate their pain: 1) right now; 2) on average over the last 7 days; 3) at its worst over the last 7 days; 4) at its best over the last 7 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>temporal summation of second pain</measure>
      <time_frame>baseline, 4- and 12-weeks post-randomization.</time_frame>
      <description>Participants will receive a total of 160 painful laser stimuli, 80 single-pulse stimuli and 80 pulse trains (3 pulses delivered at 0.67 Hz). After each stimulus, participants will be prompted to rate second pain with the display of a numerical pain rating scale. The pain ratings of single pulses will be subtracted from the pain ratings of pulse trains to estimate the intensity of the temporal summation of second pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>low back pain frequency and duration</measure>
      <time_frame>baseline, 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.</time_frame>
      <description>A modified version of the pain frequency-severity-duration scale will be used. Participants will be instructed to answer these 3 questions:&#xD;
  Is the pain recurrent (it comes in episodes) or continuous (it is always present)?&#xD;
  How many days in the past week have you had low back pain? (0, 1, 2, 3, 4, 5, 6, 7 days; a higher score means a worse outcome)&#xD;
  On average, how many hours per day does the pain last? (0; 1-4; 5-8; 9-12; 13-16; 17-20; 21-24 hours; a higher score means a worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pressure pain thresholds (PPTs)</measure>
      <time_frame>baseline, 4- and 12-weeks post-randomization.</time_frame>
      <description>PPT will be measured using a handheld digital algometer (Wagner Pain TestTM FPX, Greenwich, Connecticut, USA) and a standardized protocol. The algometer will be applied perpendicularly to the skin of the first test location and the pressure increased at approximately 50 kPa/s until pain is reported by the participant. This procedure will be repeated three times at the same test location. The PPT will be the average of the values obtained during these 3 trials. The same procedures will be repeated at the two other test locations. PPT will be tested on three different body locations: 1) Over the spinous process of the most painful vertebra between L1 and S1; 2) On the right lower limb in the dermatome corresponding to the level of the most painful vertebra; 3) in the center of the right thenar eminence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-fiber-related brain responses</measure>
      <time_frame>baseline, 4- and 12-weeks post-randomization.</time_frame>
      <description>Electroencephalography (EEG) will be recorded using a 64-channel BrainVision system with active Ag-AgCl electrodes mounted on an actiCAP, according to the International 10-20 system (Brain Products, Gilching, Germany). Electrodes will be nose-referenced, and the ground will be set at FPz. Signals will be sampled at 500 Hz. Eye movements and blinks will be recorded using electrooculography (EOG). Electrode impedance will be kept below 20 kΩ. Closed eyes resting state EEG will be recorded for 5 min prior to laser stimuli for exploratory EEG analyses. EEG activity will be recorded continuously. The outcome of interest from laser-evoked-brain activity is the response evoked by C-fiber activation. Laser-evoked potentials (LEP) and event-related spectral perturbations (ERSP) will be analyzed using validated methods.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oswestry Disability Index (ODI)</measure>
      <time_frame>baseline, 4-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.</time_frame>
      <description>Self-reported low back pain related disability will be evaluated using the French-Canadian version of the ODI (0-100%; a higher score means a worse outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Back performance scale (BPS)</measure>
      <time_frame>baseline, 4- and 12-weeks post-randomization.</time_frame>
      <description>The BPS will be used as a performance based outcome of physical function. It includes five daily activities such as putting socks on or picking something on the floor (see PMID: 12444880 for more details). Each activity is rated from 0 to 3, and the five scores are added up (min = 0, max = 15; a higher score means a worse outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Five times sit-to-stand test</measure>
      <time_frame>baseline, 4- and 12-weeks post-randomization.</time_frame>
      <description>The five times sit-to-stand test will be used as performance based outcome of physical function. Participant sitting on a supported chair will be instructed to stand and sit again as fast as possible, five times in a row. Time will be measured in seconds. The test will be performed twice and the average time for the two trials will be recorded (a higher score means a worse outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression</measure>
      <time_frame>baseline, 4- and 12-weeks post-randomization.</time_frame>
      <description>Depression levels will be measured using the French-Canadian version of the Beck Depression Inventory (BDI; min = 0, max = 63; a higher score means a worse outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>baseline, 4- and 12-weeks post-randomization.</time_frame>
      <description>Anxiety levels will be measured using the French-Canadian version of the State-Trait Anxiety Inventory, version Y (STAI-Y; min = 20, max = 80; a higher score means a worse outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain catastrophizing</measure>
      <time_frame>baseline, 4- and 12-weeks post-randomization.</time_frame>
      <description>The main elements contributing to the pain experience according to the fear avoidance model of pain will be measured. Pain catastrophizing will be measured with the French-Canadian version of the pain catastrophizing scale (PCS; min = 0, max = 52; a higher score means a worse outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Kinesiophobia</measure>
      <time_frame>baseline, 4- and 12-weeks post-randomization.</time_frame>
      <description>The main elements contributing to the pain experience according to the fear avoidance model of pain will be measured. Pain-related fear will be measured with a French adaptation of the Tampa scale for kinesiophobia (TSK; min = 17, max = 68; a higher score means a worse outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain vigilance</measure>
      <time_frame>baseline, 4- and 12-weeks post-randomization.</time_frame>
      <description>The main elements contributing to the pain experience according to the fear avoidance model of pain will be measured. Hypervigilance will be measured with a French adaptation of the pain vigilance and awareness questionnaire (PVAQ; min = 0, max = 80; a higher score means a worse outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's global impression of change</measure>
      <time_frame>After the last treatment session (12-weeks post-randomization)</time_frame>
      <description>Participants will be instructed to give their global impression of change on a scale from -100 to 100 (-100 = very much worse, 0 = no change, 100 = very much improved).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Expectations of pain relief</measure>
      <time_frame>baseline and 4-weeks post-randomization.</time_frame>
      <description>Participants will be instructed to rate their expectations of pain relief after the treatment on a scale from 0 to 100, 0 being &quot;no relief&quot; and 100 being &quot;complete relief&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Contextual factors (healing encounters and attitudes lists (HEAL))</measure>
      <time_frame>baseline, 4- and 12-weeks post-randomization.</time_frame>
      <description>Contextual factors will be measured using a French adaptation of the healing encounters and attitudes lists (HEAL).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Adverse events (AE)</measure>
      <time_frame>1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 13-weeks post-randomization.</time_frame>
      <description>Participants will be informed of the risk of AE and the importance to communicate any unpleasant or abnormal sensation occurring in the hours or days following a treatment. Mild AE are defined as transient reactions (≤ 48 h) that do not require further treatment. Moderate AE are defined as reactions lasting more than 48 h, limiting function or daily activity and possibly requiring additional care. Severe AE are defined as reactions requiring hospital admission, life threatening, or causing long-lasting disability.</description>
    </other_outcome>
    <other_outcome>
      <measure>Blinding</measure>
      <time_frame>After the last treatment session (12-weeks post-randomization)</time_frame>
      <description>Blinding will be assessed by asking these questions: 1) Do you think that you received a real chiropractic treatment for low back pain? (yes / no) 2) How certain are you on a scale of 0 to 10, where 0 indicates certainty of not having received a chiropractic treatment, 5 indicates absolute uncertainty, and 10 absolute certainty of having received a chiropractic treatment</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of other treatments for low back pain</measure>
      <time_frame>1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-weeks post-randomization.</time_frame>
      <description>Participants will be informed about the possibility to seek care for their low back pain outside the study at any point, if necessary. Based on recent Canadian practice guidelines for chronic LBP, exercise and oral nonsteroidal anti-inflammatory drugs (NSAIDs) will be recommended as first alternatives to interventions provided in the study. However, participants may receive other treatments. The number of concomitant treatments will be measured once a week by asking these questions:&#xD;
  In the past 7 days, have you used or received any other treatment for low back pain than the one provided in this study? (yes / no)&#xD;
  If so, please specify the number of treatments you received (for example: the number of pills taken, the number of therapy sessions, etc.).</description>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">112</enrollment>
    <condition>Chronic Low-back Pain</condition>
    <arm_group>
      <arm_group_label>lumbar spinal manipulative therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive spinal manipulative therapy (SMT) exclusively at dysfunctional lumbar segments. Participants will receive 36 SMT sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform two spinal manipulations, one on each side of the most painful lumbar vertebra. During spinal manipulations, participants will lay on their side and they will be instructed to inhale and exhale fully before each thrust.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>full spine spinal manipulative therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive spinal manipulative therapy (SMT) at dysfunctional spinal segments in the lumbar AND other spine regions. Participants will receive 36 spinal manipulative therapy (SMT) sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform a minimum of two spinal manipulations, one on each side of the most painful lumbar vertebra. Spinal manipulation will also be delivered at other dysfunctional spinal segments, based on clinical examination. During spinal manipulations, participants will lay prone, supine or on their side and they will be instructed to inhale and exhale fully before each thrust.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>sham spinal manipulative therapy</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Participants will receive 36 sham SMT sessions (3x/week for 12 weeks, each session ≈15 min). This will target dysfunctional segments in the lumbar and other spine regions. Three maneuvers will be used:&#xD;
  Ventral decubitus: 1 to 5 light and brief manual contacts (≈ 20 N and 5 s) will be applied and quickly released over the spinous process of dysfunctional vertebrae identified during clinical examination.&#xD;
  Dorsal decubitus: sections of the treatment table will be slightly raised or lowered (≈ 5 cm) and their lower limbs' position changed once or twice e.g., knees bent, hips internally or externally rotated. Each position maintained during ≈ 30 s.&#xD;
  Lateral decubitus: 1 to 5 impulses at the lowest setting of the Activator V instrument (Activator Methods Int. Ltd., Phoenix, Arizona, USA) will be applied on their gluteus and quadratus lumborum muscles. The position of the instrument will change after each impulse.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>no intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This fourth arm will comprise healthy volunteers (age/sex-matched to the participants in the test intervention - lumbar group) who will not receive any intervention. The main purpose of this fourth group is to provide reference values to interpret some results obtained in participants with chronic primary low back pain.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>lumbar spinal manipulative therapy</intervention_name>
      <description>Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops).</description>
      <arm_group_label>lumbar spinal manipulative therapy</arm_group_label>
      <other_name>spinal manipulation</other_name>
      <other_name>chiropractic adjustment</other_name>
      <other_name>grade 5 spinal mobilization</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>sham spinal manipulative therapy</intervention_name>
      <description>Sham spinal manipulative therapy (sham SMT), was designed to be structurally equivalent to SMT, i.e., to attend to the same body regions with the same amount of contact as well as to have the same number, frequency and length of sessions. SMT and sham SMT will be provided by the same treatment provider and will appear to be similarly tailored to the participants' condition. Sham SMT does not share the component of interest of SMT, i.e., the activation of deep high-threshold mechanoreceptors via high-velocity, low-amplitude thrusts applied to the spine. Yet, it shares all the other components not of interest in this study that may contribute to the placebo response, such as therapeutic alliance, contextual factors, physical touch, and expectations. Furthermore, deception will be used to balance expectations and enhance blinding.</description>
      <arm_group_label>sham spinal manipulative therapy</arm_group_label>
      <other_name>control intervention</other_name>
      <other_name>sham control</other_name>
      <other_name>sham treatment</other_name>
      <other_name>placebo</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>full spine spinal manipulative therapy</intervention_name>
      <description>Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops).</description>
      <arm_group_label>full spine spinal manipulative therapy</arm_group_label>
      <other_name>spinal manipulation</other_name>
      <other_name>chiropractic adjustment</other_name>
      <other_name>grade 5 spinal mobilization</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Duration of current low back pain (LBP) episode ≥ 6 months;&#xD;
  &#xD;
            -  Average LBP intensity during the last 7 days ≥ 3/10;&#xD;
  &#xD;
            -  (For healthy volunteers only) To be of the same sex and age (± 1 year) as a&#xD;
               participant with low back pain.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of back conditions other than chronic primary LBP e.g., failed back surgery&#xD;
               syndrome, spondylosis, spondylolisthesis, spinal stenosis, herniated disc, infection,&#xD;
               etc.;&#xD;
  &#xD;
            -  Presence of pain in another body location that is more severe than the pain in the&#xD;
               lower back;&#xD;
  &#xD;
            -  Presence of a neurological deficit i.e., sensation loss, muscle weakness, decreased&#xD;
               deep tendon reflexes;&#xD;
  &#xD;
            -  Presence of contraindications to spinal manipulative therapy e.g., recent fracture,&#xD;
               history of spinal surgery, cauda equina syndrome, inflammatory arthritis, taking&#xD;
               anticoagulant medication, active cancer, moderate to severe osteoporosis, abdominal&#xD;
               aortic aneurysm;&#xD;
  &#xD;
            -  Underwent surgery in the last 3 months;&#xD;
  &#xD;
            -  Pregnancy, ≤ 3 months post-partum or planning to get pregnant in the next 12 months;&#xD;
  &#xD;
            -  History of spinal manipulative therapy in the past 12 months;&#xD;
  &#xD;
            -  Scoliosis ≥ 20°;&#xD;
  &#xD;
            -  BMI ≥ 40;&#xD;
  &#xD;
            -  Insufficient language skills in French to complete the questionnaires;&#xD;
  &#xD;
            -  Open or pending litigation for LBP or seeking/receiving disability compensation;&#xD;
  &#xD;
            -  Diagnosis of an illness affecting the sensorimotor functions e.g., diabetes, multiple&#xD;
               sclerosis, amyotrophic lateral sclerosis;&#xD;
  &#xD;
            -  Diagnosis of mental health disorders (with the exception of anxiety and depression);&#xD;
  &#xD;
            -  Current drug or alcohol dependence;&#xD;
  &#xD;
            -  Skin of type I on the Fitzpatrick scale;&#xD;
  &#xD;
            -  (For healthy volunteers only) Regular use of pain medication or usage in the 48 h&#xD;
               prior to data collection;&#xD;
  &#xD;
            -  (For healthy volunteers only) History of chronic pain;&#xD;
  &#xD;
            -  (For healthy volunteers only) Acute pain on the days of data collection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mathieu Piché</last_name>
      <role>Principal Investigator</role>
      <affiliation>Université du Québec à Trois-Rivières</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Benjamin Provencher</last_name>
      <phone>1-819-376-5011</phone>
      <phone_ext>4996</phone_ext>
      <email>metric@uqtr.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mathieu Piché</last_name>
      <phone>1-819-376-5011</phone>
      <phone_ext>3998</phone_ext>
      <email>metric@uqtr.ca</email>
    </overall_contact_backup>
    <reference>
      <citation>Buchbinder R, Underwood M, Hartvigsen J, Maher CG. The Lancet Series call to action to reduce low value care for low back pain: an update. Pain. 2020 Sep;161 Suppl 1(1):S57-S64. doi: 10.1097/j.pain.0000000000001869. No abstract available.</citation>
      <PMID>33090740</PMID>
    </reference>
    <reference>
      <citation>Cormier S, Lavigne GL, Choiniere M, Rainville P. Expectations predict chronic pain treatment outcomes. Pain. 2016 Feb;157(2):329-338. doi: 10.1097/j.pain.0000000000000379.</citation>
      <PMID>26447703</PMID>
    </reference>
    <reference>
      <citation>Corp N, Mansell G, Stynes S, Wynne-Jones G, Morso L, Hill JC, van der Windt DA. Evidence-based treatment recommendations for neck and low back pain across Europe: A systematic review of guidelines. Eur J Pain. 2021 Feb;25(2):275-295. doi: 10.1002/ejp.1679. Epub 2020 Nov 12.</citation>
      <PMID>33064878</PMID>
    </reference>
    <reference>
      <citation>Dieleman JL, Cao J, Chapin A, Chen C, Li Z, Liu A, Horst C, Kaldjian A, Matyasz T, Scott KW, Bui AL, Campbell M, Duber HC, Dunn AC, Flaxman AD, Fitzmaurice C, Naghavi M, Sadat N, Shieh P, Squires E, Yeung K, Murray CJL. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020 Mar 3;323(9):863-884. doi: 10.1001/jama.2020.0734.</citation>
      <PMID>32125402</PMID>
    </reference>
    <reference>
      <citation>Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.</citation>
      <PMID>15621359</PMID>
    </reference>
    <reference>
      <citation>Fitzcharles MA, Cohen SP, Clauw DJ, Littlejohn G, Usui C, Hauser W. Chronic primary musculoskeletal pain: a new concept of nonstructural regional pain. Pain Rep. 2022 Aug 9;7(5):e1024. doi: 10.1097/PR9.0000000000001024. eCollection 2022 Sep-Oct.</citation>
      <PMID>35975135</PMID>
    </reference>
    <reference>
      <citation>Funabashi M, Gorrell LM, Pohlman KA, Bergna A, Heneghan NR. Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review. PLoS One. 2022 Jul 15;17(7):e0270671. doi: 10.1371/journal.pone.0270671. eCollection 2022.</citation>
      <PMID>35839253</PMID>
    </reference>
    <reference>
      <citation>George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.</citation>
      <PMID>34719942</PMID>
    </reference>
    <reference>
      <citation>Gevers-Montoro C, Provencher B, Descarreaux M, Ortega de Mues A, Piche M. Neurophysiological mechanisms of chiropractic spinal manipulation for spine pain. Eur J Pain. 2021 Aug;25(7):1429-1448. doi: 10.1002/ejp.1773. Epub 2021 Apr 15.</citation>
      <PMID>33786932</PMID>
    </reference>
    <reference>
      <citation>Gevers-Montoro C, Provencher B, Northon S, Stedile-Lovatel JP, Ortega de Mues A, Piche M. Chiropractic Spinal Manipulation Prevents Secondary Hyperalgesia Induced by Topical Capsaicin in Healthy Individuals. Front Pain Res (Lausanne). 2021 Jul 20;2:702429. doi: 10.3389/fpain.2021.702429. eCollection 2021.</citation>
      <PMID>35295504</PMID>
    </reference>
    <reference>
      <citation>Graven-Nielsen T. Mechanisms and manifestations in musculoskeletal pain: from experimental to clinical pain settings. Pain. 2022 Nov 1;163(Suppl 1):S29-S45. doi: 10.1097/j.pain.0000000000002690. Epub 2022 May 15. No abstract available.</citation>
      <PMID>35984370</PMID>
    </reference>
    <reference>
      <citation>Greco CM, Yu L, Johnston KL, Dodds NE, Morone NE, Glick RM, Schneider MJ, Klem ML, McFarland CE, Lawrence S, Colditz J, Maihoefer CC, Jonas WB, Ryan ND, Pilkonis PA. Measuring nonspecific factors in treatment: item banks that assess the healthcare experience and attitudes from the patient's perspective. Qual Life Res. 2016 Jul;25(7):1625-34. doi: 10.1007/s11136-015-1178-1. Epub 2015 Nov 12.</citation>
      <PMID>26563249</PMID>
    </reference>
    <reference>
      <citation>Haas M, Vavrek D, Peterson D, Polissar N, Neradilek MB. Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial. Spine J. 2014 Jul 1;14(7):1106-16. doi: 10.1016/j.spinee.2013.07.468. Epub 2013 Oct 16.</citation>
      <PMID>24139233</PMID>
    </reference>
    <reference>
      <citation>Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.</citation>
      <PMID>29573870</PMID>
    </reference>
    <reference>
      <citation>Hohenschurz-Schmidt D, Vase L, Scott W, Annoni M, Ajayi OK, Barth J, Bennell K, Berna C, Bialosky J, Braithwaite F, Finnerup NB, Williams ACC, Carlino E, Cerritelli F, Chaibi A, Cherkin D, Colloca L, Cote P, Darnall BD, Evans R, Fabre L, Faria V, French S, Gerger H, Hauser W, Hinman RS, Ho D, Janssens T, Jensen K, Johnston C, Juhl Lunde S, Keefe F, Kerns RD, Koechlin H, Kongsted A, Michener LA, Moerman DE, Musial F, Newell D, Nicholas M, Palermo TM, Palermo S, Peerdeman KJ, Pogatzki-Zahn EM, Puhl AA, Roberts L, Rossettini G, Tomczak Matthiesen S, Underwood M, Vaucher P, Vollert J, Wartolowska K, Weimer K, Werner CP, Rice ASC, Draper-Rodi J. Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies: the CoPPS Statement. BMJ. 2023 May 25;381:e072108. doi: 10.1136/bmj-2022-072108. No abstract available.</citation>
      <PMID>37230508</PMID>
    </reference>
    <reference>
      <citation>Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.</citation>
      <PMID>29480409</PMID>
    </reference>
    <reference>
      <citation>Korownyk CS, Montgomery L, Young J, Moore S, Singer AG, MacDougall P, Darling S, Ellis K, Myers J, Rochford C, Taillefer MC, Allan GM, Perry D, Moe SS, Ton J, Kolber MR, Kirkwood J, Thomas B, Garrison S, McCormack JP, Falk J, Dugre N, Sept L, Turgeon RD, Paige A, Potter J, Nickonchuk T, Train AD, Weresch J, Chan K, Lindblad AJ. PEER simplified chronic pain guideline: Management of chronic low back, osteoarthritic, and neuropathic pain in primary care. Can Fam Physician. 2022 Mar;68(3):179-190. doi: 10.46747/cfp.6803179.</citation>
      <PMID>35292455</PMID>
    </reference>
    <reference>
      <citation>Kosek E, Clauw D, Nijs J, Baron R, Gilron I, Harris RE, Mico JA, Rice ASC, Sterling M. Chronic nociplastic pain affecting the musculoskeletal system: clinical criteria and grading system. Pain. 2021 Nov 1;162(11):2629-2634. doi: 10.1097/j.pain.0000000000002324. No abstract available.</citation>
      <PMID>33974577</PMID>
    </reference>
    <reference>
      <citation>Latremoliere A, Woolf CJ. Central sensitization: a generator of pain hypersensitivity by central neural plasticity. J Pain. 2009 Sep;10(9):895-926. doi: 10.1016/j.jpain.2009.06.012.</citation>
      <PMID>19712899</PMID>
    </reference>
    <reference>
      <citation>McPhee ME, Vaegter HB, Graven-Nielsen T. Alterations in pronociceptive and antinociceptive mechanisms in patients with low back pain: a systematic review with meta-analysis. Pain. 2020 Mar;161(3):464-475. doi: 10.1097/j.pain.0000000000001737.</citation>
      <PMID>32049888</PMID>
    </reference>
    <reference>
      <citation>Mucke M, Cuhls H, Radbruch L, Baron R, Maier C, Tolle T, Treede RD, Rolke R. Quantitative sensory testing (QST). English version. Schmerz. 2021 Nov;35(Suppl 3):153-160. doi: 10.1007/s00482-015-0093-2.</citation>
      <PMID>26826097</PMID>
    </reference>
    <reference>
      <citation>Nicholas M, Vlaeyen JWS, Rief W, Barke A, Aziz Q, Benoliel R, Cohen M, Evers S, Giamberardino MA, Goebel A, Korwisi B, Perrot S, Svensson P, Wang SJ, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic primary pain. Pain. 2019 Jan;160(1):28-37. doi: 10.1097/j.pain.0000000000001390.</citation>
      <PMID>30586068</PMID>
    </reference>
    <reference>
      <citation>Nijs J, Apeldoorn A, Hallegraeff H, Clark J, Smeets R, Malfliet A, Girbes EL, De Kooning M, Ickmans K. Low back pain: guidelines for the clinical classification of predominant neuropathic, nociceptive, or central sensitization pain. Pain Physician. 2015 May-Jun;18(3):E333-46.</citation>
      <PMID>26000680</PMID>
    </reference>
    <reference>
      <citation>Nim CG, Kawchuk GN, Schiottz-Christensen B, O'Neill S. The effect on clinical outcomes when targeting spinal manipulation at stiffness or pain sensitivity: a randomized trial. Sci Rep. 2020 Sep 3;10(1):14615. doi: 10.1038/s41598-020-71557-y.</citation>
      <PMID>32884045</PMID>
    </reference>
    <reference>
      <citation>Ozudogru A, Canli M, Ceylan I, Kuzu S, Alkan H, Karacay BC. Five Times Sit-to-Stand Test in people with non-specific chronic low back pain-a cross-sectional test-retest reliability study. Ir J Med Sci. 2023 Aug;192(4):1903-1908. doi: 10.1007/s11845-022-03223-3. Epub 2022 Nov 15.</citation>
      <PMID>36376556</PMID>
    </reference>
    <reference>
      <citation>Plaghki L, Mouraux A. How do we selectively activate skin nociceptors with a high power infrared laser? Physiology and biophysics of laser stimulation. Neurophysiol Clin. 2003 Dec;33(6):269-77. doi: 10.1016/j.neucli.2003.10.003.</citation>
      <PMID>14678841</PMID>
    </reference>
    <reference>
      <citation>Plaghki L, Mouraux A. EEG and laser stimulation as tools for pain research. Curr Opin Investig Drugs. 2005 Jan;6(1):58-64.</citation>
      <PMID>15675604</PMID>
    </reference>
    <reference>
      <citation>Provencher B, Northon S, Gevers Montoro C, O'Shaughnessy J, Piche M. Effects of chiropractic spinal manipulation on laser-evoked pain and brain activity. J Physiol Sci. 2021 Jun 24;71(1):20. doi: 10.1186/s12576-021-00804-2.</citation>
      <PMID>34167458</PMID>
    </reference>
    <reference>
      <citation>Provencher B, Northon S, Piche M. Segmental Chiropractic Spinal Manipulation Does not Reduce Pain Amplification and the Associated Pain-Related Brain Activity in a Capsaicin-Heat Pain Model. Front Pain Res (Lausanne). 2021 Nov 1;2:733727. doi: 10.3389/fpain.2021.733727. eCollection 2021.</citation>
      <PMID>35295444</PMID>
    </reference>
    <reference>
      <citation>Puhl AA, Reinhart CJ, Doan JB, Vernon H. The quality of placebos used in randomized, controlled trials of lumbar and pelvic joint thrust manipulation-a systematic review. Spine J. 2017 Mar;17(3):445-456. doi: 10.1016/j.spinee.2016.11.003. Epub 2016 Nov 22.</citation>
      <PMID>27888138</PMID>
    </reference>
    <reference>
      <citation>Schaffler K, Nicolas LB, Borta A, Brand T, Reitmeir P, Roebling R, Scholpp J. Investigation of the predictive validity of laser-EPs in normal, UVB-inflamed and capsaicin-irritated skin with four analgesic compounds in healthy volunteers. Br J Clin Pharmacol. 2017 Jul;83(7):1424-1435. doi: 10.1111/bcp.13247. Epub 2017 Feb 27.</citation>
      <PMID>28139023</PMID>
    </reference>
    <reference>
      <citation>Shraim MA, Masse-Alarie H, Hall LM, Hodges PW. Systematic Review and Synthesis of Mechanism-based Classification Systems for Pain Experienced in the Musculoskeletal System. Clin J Pain. 2020 Oct;36(10):793-812. doi: 10.1097/AJP.0000000000000860.</citation>
      <PMID>32852923</PMID>
    </reference>
    <reference>
      <citation>Starkweather AR, Heineman A, Storey S, Rubia G, Lyon DE, Greenspan J, Dorsey SG. Methods to measure peripheral and central sensitization using quantitative sensory testing: A focus on individuals with low back pain. Appl Nurs Res. 2016 Feb;29:237-41. doi: 10.1016/j.apnr.2015.03.013. Epub 2015 Apr 8.</citation>
      <PMID>26856520</PMID>
    </reference>
    <reference>
      <citation>Stevans JM, Delitto A, Khoja SS, Patterson CG, Smith CN, Schneider MJ, Freburger JK, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Friedman M, Beneciuk JM, George SZ, Saper RB. Risk Factors Associated With Transition From Acute to Chronic Low Back Pain in US Patients Seeking Primary Care. JAMA Netw Open. 2021 Feb 1;4(2):e2037371. doi: 10.1001/jamanetworkopen.2020.37371.</citation>
      <PMID>33591367</PMID>
    </reference>
    <reference>
      <citation>Strand LI, Moe-Nilssen R, Ljunggren AE. Back Performance Scale for the assessment of mobility-related activities in people with back pain. Phys Ther. 2002 Dec;82(12):1213-23.</citation>
      <PMID>12444880</PMID>
    </reference>
    <reference>
      <citation>Verdugo RJ, Matamala JM, Inui K, Kakigi R, Valls-Sole J, Hansson P, Nilsen KB, Lombardi R, Lauria G, Petropoulos IN, Malik RA, Treede RD, Baumgartner U, Jara PA, Campero M. Review of techniques useful for the assessment of sensory small fiber neuropathies: Report from an IFCN expert group. Clin Neurophysiol. 2022 Apr;136:13-38. doi: 10.1016/j.clinph.2022.01.002. Epub 2022 Jan 19.</citation>
      <PMID>35131635</PMID>
    </reference>
    <reference>
      <citation>Vlaeyen JWS, Crombez G, Linton SJ. The fear-avoidance model of pain. Pain. 2016 Aug;157(8):1588-1589. doi: 10.1097/j.pain.0000000000000574. No abstract available.</citation>
      <PMID>27428892</PMID>
    </reference>
    <reference>
      <citation>Wheeler CHB, Williams ACC, Morley SJ. Meta-analysis of the psychometric properties of the Pain Catastrophizing Scale and associations with participant characteristics. Pain. 2019 Sep;160(9):1946-1953. doi: 10.1097/j.pain.0000000000001494.</citation>
      <PMID>30694929</PMID>
    </reference>
    <reference>
      <citation>Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.</citation>
      <PMID>24402217</PMID>
    </reference>
    <reference>
      <citation>Denis I, Fortin L. Development of a French-Canadian version of the Oswestry Disability Index: cross-cultural adaptation and validation. Spine (Phila Pa 1976). 2012 Apr 1;37(7):E439-44. doi: 10.1097/BRS.0b013e318233eaf9.</citation>
      <PMID>22037523</PMID>
    </reference>
    <reference>
      <citation>Poquet N, Lin C. The Brief Pain Inventory (BPI). J Physiother. 2016 Jan;62(1):52. doi: 10.1016/j.jphys.2015.07.001. Epub 2015 Aug 21. No abstract available.</citation>
      <PMID>26303366</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Université du Québec à Trois-Rivières</investigator_affiliation>
      <investigator_full_name>Mathieu Piché</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>chronic primary low back pain</keyword>
    <keyword>spinal manipulative therapy</keyword>
    <keyword>nociplastic pain</keyword>
    <keyword>central sensitization</keyword>
    <keyword>C-fibers</keyword>
    <keyword>brain</keyword>
    <keyword>electroencephalography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Back Pain</mesh_term>
      <mesh_term>Low Back Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>After publication of the results, the data that support the findings of this study will be available from the corresponding author, MP, upon reasonable request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will become available upon publication of the results (expected in January 2026). They will be available for the next 5 years.</ipd_time_frame>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Statistical Analysis Plan</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>July 25, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT05986370/SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05986370
  org study id: METRIC
  nct id: NCT05986370
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test the effects of spinal manipulative therapy in
        individuals with chronic primary low back pain and determine the neurophysiological
        mechanisms underlying pain relief. The main questions it aims to answer are: • Is pain relief
        produced by spinal manipulative therapy in patients with chronic primary low back pain caused
        by a reduction of C-fiber-related nociceptive processing? • Are these effects greater when
        spinal manipulative therapy is applied to the whole spine where it is clinically indicated
        compared with lumbar spine only? • Are these effects greater after 36 treatments over 3
        months compared with 12 treatments over 1 month. Participants will receive spinal
        manipulative therapy (all clinically indicated spine segments or back only) or a control
        intervention. A group of healthy volunteers will be recruited to assess secondary outcome
        measures over the same time period, as reference data for comparisons. Researchers will
        compare the two groups receiving spinal manipulative therapy to the group receiving the
        control intervention to see if clinical pain relief and the reduction of temporal summation
        of second pain (produced experimentally) is significantly greater with spinal manipulative
        therapy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: low back pain intensity
  time frame: baseline, 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.
  description: In accordance with recommendations for chronic pain trials, participants will be instructed to rate the intensity of their LBP using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). As in the brief pain inventory (BPI), they will be instructed to rate their pain: 1) right now; 2) on average over the last 7 days; 3) at its worst over the last 7 days; 4) at its best over the last 7 days.
  measure: temporal summation of second pain
  time frame: baseline, 4- and 12-weeks post-randomization.
  description: Participants will receive a total of 160 painful laser stimuli, 80 single-pulse stimuli and 80 pulse trains (3 pulses delivered at 0.67 Hz). After each stimulus, participants will be prompted to rate second pain with the display of a numerical pain rating scale. The pain ratings of single pulses will be subtracted from the pain ratings of pulse trains to estimate the intensity of the temporal summation of second pain.
  measure: low back pain frequency and duration
  time frame: baseline, 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.
  description: A modified version of the pain frequency-severity-duration scale will be used. Participants will be instructed to answer these 3 questions:
  Is the pain recurrent (it comes in episodes) or continuous (it is always present)?
  How many days in the past week have you had low back pain? (0, 1, 2, 3, 4, 5, 6, 7 days; a higher score means a worse outcome)
  On average, how many hours per day does the pain last? (0; 1-4; 5-8; 9-12; 13-16; 17-20; 21-24 hours; a higher score means a worse outcome)
  measure: Pressure pain thresholds (PPTs)
  time frame: baseline, 4- and 12-weeks post-randomization.
  description: PPT will be measured using a handheld digital algometer (Wagner Pain TestTM FPX, Greenwich, Connecticut, USA) and a standardized protocol. The algometer will be applied perpendicularly to the skin of the first test location and the pressure increased at approximately 50 kPa/s until pain is reported by the participant. This procedure will be repeated three times at the same test location. The PPT will be the average of the values obtained during these 3 trials. The same procedures will be repeated at the two other test locations. PPT will be tested on three different body locations: 1) Over the spinous process of the most painful vertebra between L1 and S1; 2) On the right lower limb in the dermatome corresponding to the level of the most painful vertebra; 3) in the center of the right thenar eminence.
  measure: C-fiber-related brain responses
  time frame: baseline, 4- and 12-weeks post-randomization.
  description: Electroencephalography (EEG) will be recorded using a 64-channel BrainVision system with active Ag-AgCl electrodes mounted on an actiCAP, according to the International 10-20 system (Brain Products, Gilching, Germany). Electrodes will be nose-referenced, and the ground will be set at FPz. Signals will be sampled at 500 Hz. Eye movements and blinks will be recorded using electrooculography (EOG). Electrode impedance will be kept below 20 kΩ. Closed eyes resting state EEG will be recorded for 5 min prior to laser stimuli for exploratory EEG analyses. EEG activity will be recorded continuously. The outcome of interest from laser-evoked-brain activity is the response evoked by C-fiber activation. Laser-evoked potentials (LEP) and event-related spectral perturbations (ERSP) will be analyzed using validated methods.
  measure: Oswestry Disability Index (ODI)
  time frame: baseline, 4-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.
  description: Self-reported low back pain related disability will be evaluated using the French-Canadian version of the ODI (0-100%; a higher score means a worse outcome).
  measure: Back performance scale (BPS)
  time frame: baseline, 4- and 12-weeks post-randomization.
  description: The BPS will be used as a performance based outcome of physical function. It includes five daily activities such as putting socks on or picking something on the floor (see PMID: 12444880 for more details). Each activity is rated from 0 to 3, and the five scores are added up (min = 0, max = 15; a higher score means a worse outcome).
  measure: Five times sit-to-stand test
  time frame: baseline, 4- and 12-weeks post-randomization.
  description: The five times sit-to-stand test will be used as performance based outcome of physical function. Participant sitting on a supported chair will be instructed to stand and sit again as fast as possible, five times in a row. Time will be measured in seconds. The test will be performed twice and the average time for the two trials will be recorded (a higher score means a worse outcome).
  measure: Depression
  time frame: baseline, 4- and 12-weeks post-randomization.
  description: Depression levels will be measured using the French-Canadian version of the Beck Depression Inventory (BDI; min = 0, max = 63; a higher score means a worse outcome).
  measure: Anxiety
  time frame: baseline, 4- and 12-weeks post-randomization.
  description: Anxiety levels will be measured using the French-Canadian version of the State-Trait Anxiety Inventory, version Y (STAI-Y; min = 20, max = 80; a higher score means a worse outcome).
  measure: Pain catastrophizing
  time frame: baseline, 4- and 12-weeks post-randomization.
  description: The main elements contributing to the pain experience according to the fear avoidance model of pain will be measured. Pain catastrophizing will be measured with the French-Canadian version of the pain catastrophizing scale (PCS; min = 0, max = 52; a higher score means a worse outcome).
  measure: Kinesiophobia
  time frame: baseline, 4- and 12-weeks post-randomization.
  description: The main elements contributing to the pain experience according to the fear avoidance model of pain will be measured. Pain-related fear will be measured with a French adaptation of the Tampa scale for kinesiophobia (TSK; min = 17, max = 68; a higher score means a worse outcome).
  measure: Pain vigilance
  time frame: baseline, 4- and 12-weeks post-randomization.
  description: The main elements contributing to the pain experience according to the fear avoidance model of pain will be measured. Hypervigilance will be measured with a French adaptation of the pain vigilance and awareness questionnaire (PVAQ; min = 0, max = 80; a higher score means a worse outcome).
  measure: Patient's global impression of change
  time frame: After the last treatment session (12-weeks post-randomization)
  description: Participants will be instructed to give their global impression of change on a scale from -100 to 100 (-100 = very much worse, 0 = no change, 100 = very much improved).
  measure: Expectations of pain relief
  time frame: baseline and 4-weeks post-randomization.
  description: Participants will be instructed to rate their expectations of pain relief after the treatment on a scale from 0 to 100, 0 being "no relief" and 100 being "complete relief".
  measure: Contextual factors (healing encounters and attitudes lists (HEAL))
  time frame: baseline, 4- and 12-weeks post-randomization.
  description: Contextual factors will be measured using a French adaptation of the healing encounters and attitudes lists (HEAL).
  measure: Adverse events (AE)
  time frame: 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 13-weeks post-randomization.
  description: Participants will be informed of the risk of AE and the importance to communicate any unpleasant or abnormal sensation occurring in the hours or days following a treatment. Mild AE are defined as transient reactions (≤ 48 h) that do not require further treatment. Moderate AE are defined as reactions lasting more than 48 h, limiting function or daily activity and possibly requiring additional care. Severe AE are defined as reactions requiring hospital admission, life threatening, or causing long-lasting disability.
  measure: Blinding
  time frame: After the last treatment session (12-weeks post-randomization)
  description: Blinding will be assessed by asking these questions: 1) Do you think that you received a real chiropractic treatment for low back pain? (yes / no) 2) How certain are you on a scale of 0 to 10, where 0 indicates certainty of not having received a chiropractic treatment, 5 indicates absolute uncertainty, and 10 absolute certainty of having received a chiropractic treatment
  measure: Number of other treatments for low back pain
  time frame: 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-weeks post-randomization.
  description: Participants will be informed about the possibility to seek care for their low back pain outside the study at any point, if necessary. Based on recent Canadian practice guidelines for chronic LBP, exercise and oral nonsteroidal anti-inflammatory drugs (NSAIDs) will be recommended as first alternatives to interventions provided in the study. However, participants may receive other treatments. The number of concomitant treatments will be measured once a week by asking these questions:
  In the past 7 days, have you used or received any other treatment for low back pain than the one provided in this study? (yes / no)
  If so, please specify the number of treatments you received (for example: the number of pills taken, the number of therapy sessions, etc.).
  arm group label: lumbar spinal manipulative therapy
  arm group type: Experimental
  description: Participants will receive spinal manipulative therapy (SMT) exclusively at dysfunctional lumbar segments. Participants will receive 36 SMT sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform two spinal manipulations, one on each side of the most painful lumbar vertebra. During spinal manipulations, participants will lay on their side and they will be instructed to inhale and exhale fully before each thrust.
  arm group label: full spine spinal manipulative therapy
  arm group type: Experimental
  description: Participants will receive spinal manipulative therapy (SMT) at dysfunctional spinal segments in the lumbar AND other spine regions. Participants will receive 36 spinal manipulative therapy (SMT) sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform a minimum of two spinal manipulations, one on each side of the most painful lumbar vertebra. Spinal manipulation will also be delivered at other dysfunctional spinal segments, based on clinical examination. During spinal manipulations, participants will lay prone, supine or on their side and they will be instructed to inhale and exhale fully before each thrust.
  arm group label: sham spinal manipulative therapy
  arm group type: Sham Comparator
  description: Participants will receive 36 sham SMT sessions (3x/week for 12 weeks, each session ≈15 min). This will target dysfunctional segments in the lumbar and other spine regions. Three maneuvers will be used:
  Ventral decubitus: 1 to 5 light and brief manual contacts (≈ 20 N and 5 s) will be applied and quickly released over the spinous process of dysfunctional vertebrae identified during clinical examination.
  Dorsal decubitus: sections of the treatment table will be slightly raised or lowered (≈ 5 cm) and their lower limbs' position changed once or twice e.g., knees bent, hips internally or externally rotated. Each position maintained during ≈ 30 s.
  Lateral decubitus: 1 to 5 impulses at the lowest setting of the Activator V instrument (Activator Methods Int. Ltd., Phoenix, Arizona, USA) will be applied on their gluteus and quadratus lumborum muscles. The position of the instrument will change after each impulse.
  arm group label: no intervention
  arm group type: No Intervention
  description: This fourth arm will comprise healthy volunteers (age/sex-matched to the participants in the test intervention - lumbar group) who will not receive any intervention. The main purpose of this fourth group is to provide reference values to interpret some results obtained in participants with chronic primary low back pain.
  intervention type: Procedure
  intervention name: lumbar spinal manipulative therapy
  description: Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops).
  arm group label: lumbar spinal manipulative therapy
  other name: spinal manipulation
  other name: chiropractic adjustment
  other name: grade 5 spinal mobilization
  intervention type: Procedure
  intervention name: sham spinal manipulative therapy
  description: Sham spinal manipulative therapy (sham SMT), was designed to be structurally equivalent to SMT, i.e., to attend to the same body regions with the same amount of contact as well as to have the same number, frequency and length of sessions. SMT and sham SMT will be provided by the same treatment provider and will appear to be similarly tailored to the participants' condition. Sham SMT does not share the component of interest of SMT, i.e., the activation of deep high-threshold mechanoreceptors via high-velocity, low-amplitude thrusts applied to the spine. Yet, it shares all the other components not of interest in this study that may contribute to the placebo response, such as therapeutic alliance, contextual factors, physical touch, and expectations. Furthermore, deception will be used to balance expectations and enhance blinding.
  arm group label: sham spinal manipulative therapy
  other name: control intervention
  other name: sham control
  other name: sham treatment
  other name: placebo
  intervention type: Procedure
  intervention name: full spine spinal manipulative therapy
  description: Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops).
  arm group label: full spine spinal manipulative therapy
  other name: spinal manipulation
  other name: chiropractic adjustment
  other name: grade 5 spinal mobilization
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mathieu Piché
  role: Principal Investigator
  affiliation: Université du Québec à Trois-Rivières
  last name: Benjamin Provencher
  phone: 1-819-376-5011
  phone ext: 4996
  email: metric@uqtr.ca
  last name: Mathieu Piché
  phone: 1-819-376-5011
  phone ext: 3998
  email: metric@uqtr.ca
  citation: Buchbinder R, Underwood M, Hartvigsen J, Maher CG. The Lancet Series call to action to reduce low value care for low back pain: an update. Pain. 2020 Sep;161 Suppl 1(1):S57-S64. doi: 10.1097/j.pain.0000000000001869. No abstract available.
  PMID: 33090740
  citation: Cormier S, Lavigne GL, Choiniere M, Rainville P. Expectations predict chronic pain treatment outcomes. Pain. 2016 Feb;157(2):329-338. doi: 10.1097/j.pain.0000000000000379.
  PMID: 26447703
  citation: Corp N, Mansell G, Stynes S, Wynne-Jones G, Morso L, Hill JC, van der Windt DA. Evidence-based treatment recommendations for neck and low back pain across Europe: A systematic review of guidelines. Eur J Pain. 2021 Feb;25(2):275-295. doi: 10.1002/ejp.1679. Epub 2020 Nov 12.
  PMID: 33064878
  citation: Dieleman JL, Cao J, Chapin A, Chen C, Li Z, Liu A, Horst C, Kaldjian A, Matyasz T, Scott KW, Bui AL, Campbell M, Duber HC, Dunn AC, Flaxman AD, Fitzmaurice C, Naghavi M, Sadat N, Shieh P, Squires E, Yeung K, Murray CJL. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020 Mar 3;323(9):863-884. doi: 10.1001/jama.2020.0734.
  PMID: 32125402
  citation: Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
  PMID: 15621359
  citation: Fitzcharles MA, Cohen SP, Clauw DJ, Littlejohn G, Usui C, Hauser W. Chronic primary musculoskeletal pain: a new concept of nonstructural regional pain. Pain Rep. 2022 Aug 9;7(5):e1024. doi: 10.1097/PR9.0000000000001024. eCollection 2022 Sep-Oct.
  PMID: 35975135
  citation: Funabashi M, Gorrell LM, Pohlman KA, Bergna A, Heneghan NR. Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review. PLoS One. 2022 Jul 15;17(7):e0270671. doi: 10.1371/journal.pone.0270671. eCollection 2022.
  PMID: 35839253
  citation: George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.
  PMID: 34719942
  citation: Gevers-Montoro C, Provencher B, Descarreaux M, Ortega de Mues A, Piche M. Neurophysiological mechanisms of chiropractic spinal manipulation for spine pain. Eur J Pain. 2021 Aug;25(7):1429-1448. doi: 10.1002/ejp.1773. Epub 2021 Apr 15.
  PMID: 33786932
  citation: Gevers-Montoro C, Provencher B, Northon S, Stedile-Lovatel JP, Ortega de Mues A, Piche M. Chiropractic Spinal Manipulation Prevents Secondary Hyperalgesia Induced by Topical Capsaicin in Healthy Individuals. Front Pain Res (Lausanne). 2021 Jul 20;2:702429. doi: 10.3389/fpain.2021.702429. eCollection 2021.
  PMID: 35295504
  citation: Graven-Nielsen T. Mechanisms and manifestations in musculoskeletal pain: from experimental to clinical pain settings. Pain. 2022 Nov 1;163(Suppl 1):S29-S45. doi: 10.1097/j.pain.0000000000002690. Epub 2022 May 15. No abstract available.
  PMID: 35984370
  citation: Greco CM, Yu L, Johnston KL, Dodds NE, Morone NE, Glick RM, Schneider MJ, Klem ML, McFarland CE, Lawrence S, Colditz J, Maihoefer CC, Jonas WB, Ryan ND, Pilkonis PA. Measuring nonspecific factors in treatment: item banks that assess the healthcare experience and attitudes from the patient's perspective. Qual Life Res. 2016 Jul;25(7):1625-34. doi: 10.1007/s11136-015-1178-1. Epub 2015 Nov 12.
  PMID: 26563249
  citation: Haas M, Vavrek D, Peterson D, Polissar N, Neradilek MB. Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial. Spine J. 2014 Jul 1;14(7):1106-16. doi: 10.1016/j.spinee.2013.07.468. Epub 2013 Oct 16.
  PMID: 24139233
  citation: Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
  PMID: 29573870
  citation: Hohenschurz-Schmidt D, Vase L, Scott W, Annoni M, Ajayi OK, Barth J, Bennell K, Berna C, Bialosky J, Braithwaite F, Finnerup NB, Williams ACC, Carlino E, Cerritelli F, Chaibi A, Cherkin D, Colloca L, Cote P, Darnall BD, Evans R, Fabre L, Faria V, French S, Gerger H, Hauser W, Hinman RS, Ho D, Janssens T, Jensen K, Johnston C, Juhl Lunde S, Keefe F, Kerns RD, Koechlin H, Kongsted A, Michener LA, Moerman DE, Musial F, Newell D, Nicholas M, Palermo TM, Palermo S, Peerdeman KJ, Pogatzki-Zahn EM, Puhl AA, Roberts L, Rossettini G, Tomczak Matthiesen S, Underwood M, Vaucher P, Vollert J, Wartolowska K, Weimer K, Werner CP, Rice ASC, Draper-Rodi J. Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies: the CoPPS Statement. BMJ. 2023 May 25;381:e072108. doi: 10.1136/bmj-2022-072108. No abstract available.
  PMID: 37230508
  citation: Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.
  PMID: 29480409
  citation: Korownyk CS, Montgomery L, Young J, Moore S, Singer AG, MacDougall P, Darling S, Ellis K, Myers J, Rochford C, Taillefer MC, Allan GM, Perry D, Moe SS, Ton J, Kolber MR, Kirkwood J, Thomas B, Garrison S, McCormack JP, Falk J, Dugre N, Sept L, Turgeon RD, Paige A, Potter J, Nickonchuk T, Train AD, Weresch J, Chan K, Lindblad AJ. PEER simplified chronic pain guideline: Management of chronic low back, osteoarthritic, and neuropathic pain in primary care. Can Fam Physician. 2022 Mar;68(3):179-190. doi: 10.46747/cfp.6803179.
  PMID: 35292455
  citation: Kosek E, Clauw D, Nijs J, Baron R, Gilron I, Harris RE, Mico JA, Rice ASC, Sterling M. Chronic nociplastic pain affecting the musculoskeletal system: clinical criteria and grading system. Pain. 2021 Nov 1;162(11):2629-2634. doi: 10.1097/j.pain.0000000000002324. No abstract available.
  PMID: 33974577
  citation: Latremoliere A, Woolf CJ. Central sensitization: a generator of pain hypersensitivity by central neural plasticity. J Pain. 2009 Sep;10(9):895-926. doi: 10.1016/j.jpain.2009.06.012.
  PMID: 19712899
  citation: McPhee ME, Vaegter HB, Graven-Nielsen T. Alterations in pronociceptive and antinociceptive mechanisms in patients with low back pain: a systematic review with meta-analysis. Pain. 2020 Mar;161(3):464-475. doi: 10.1097/j.pain.0000000000001737.
  PMID: 32049888
  citation: Mucke M, Cuhls H, Radbruch L, Baron R, Maier C, Tolle T, Treede RD, Rolke R. Quantitative sensory testing (QST). English version. Schmerz. 2021 Nov;35(Suppl 3):153-160. doi: 10.1007/s00482-015-0093-2.
  PMID: 26826097
  citation: Nicholas M, Vlaeyen JWS, Rief W, Barke A, Aziz Q, Benoliel R, Cohen M, Evers S, Giamberardino MA, Goebel A, Korwisi B, Perrot S, Svensson P, Wang SJ, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic primary pain. Pain. 2019 Jan;160(1):28-37. doi: 10.1097/j.pain.0000000000001390.
  PMID: 30586068
  citation: Nijs J, Apeldoorn A, Hallegraeff H, Clark J, Smeets R, Malfliet A, Girbes EL, De Kooning M, Ickmans K. Low back pain: guidelines for the clinical classification of predominant neuropathic, nociceptive, or central sensitization pain. Pain Physician. 2015 May-Jun;18(3):E333-46.
  PMID: 26000680
  citation: Nim CG, Kawchuk GN, Schiottz-Christensen B, O'Neill S. The effect on clinical outcomes when targeting spinal manipulation at stiffness or pain sensitivity: a randomized trial. Sci Rep. 2020 Sep 3;10(1):14615. doi: 10.1038/s41598-020-71557-y.
  PMID: 32884045
  citation: Ozudogru A, Canli M, Ceylan I, Kuzu S, Alkan H, Karacay BC. Five Times Sit-to-Stand Test in people with non-specific chronic low back pain-a cross-sectional test-retest reliability study. Ir J Med Sci. 2023 Aug;192(4):1903-1908. doi: 10.1007/s11845-022-03223-3. Epub 2022 Nov 15.
  PMID: 36376556
  citation: Plaghki L, Mouraux A. How do we selectively activate skin nociceptors with a high power infrared laser? Physiology and biophysics of laser stimulation. Neurophysiol Clin. 2003 Dec;33(6):269-77. doi: 10.1016/j.neucli.2003.10.003.
  PMID: 14678841
  citation: Plaghki L, Mouraux A. EEG and laser stimulation as tools for pain research. Curr Opin Investig Drugs. 2005 Jan;6(1):58-64.
  PMID: 15675604
  citation: Provencher B, Northon S, Gevers Montoro C, O'Shaughnessy J, Piche M. Effects of chiropractic spinal manipulation on laser-evoked pain and brain activity. J Physiol Sci. 2021 Jun 24;71(1):20. doi: 10.1186/s12576-021-00804-2.
  PMID: 34167458
  citation: Provencher B, Northon S, Piche M. Segmental Chiropractic Spinal Manipulation Does not Reduce Pain Amplification and the Associated Pain-Related Brain Activity in a Capsaicin-Heat Pain Model. Front Pain Res (Lausanne). 2021 Nov 1;2:733727. doi: 10.3389/fpain.2021.733727. eCollection 2021.
  PMID: 35295444
  citation: Puhl AA, Reinhart CJ, Doan JB, Vernon H. The quality of placebos used in randomized, controlled trials of lumbar and pelvic joint thrust manipulation-a systematic review. Spine J. 2017 Mar;17(3):445-456. doi: 10.1016/j.spinee.2016.11.003. Epub 2016 Nov 22.
  PMID: 27888138
  citation: Schaffler K, Nicolas LB, Borta A, Brand T, Reitmeir P, Roebling R, Scholpp J. Investigation of the predictive validity of laser-EPs in normal, UVB-inflamed and capsaicin-irritated skin with four analgesic compounds in healthy volunteers. Br J Clin Pharmacol. 2017 Jul;83(7):1424-1435. doi: 10.1111/bcp.13247. Epub 2017 Feb 27.
  PMID: 28139023
  citation: Shraim MA, Masse-Alarie H, Hall LM, Hodges PW. Systematic Review and Synthesis of Mechanism-based Classification Systems for Pain Experienced in the Musculoskeletal System. Clin J Pain. 2020 Oct;36(10):793-812. doi: 10.1097/AJP.0000000000000860.
  PMID: 32852923
  citation: Starkweather AR, Heineman A, Storey S, Rubia G, Lyon DE, Greenspan J, Dorsey SG. Methods to measure peripheral and central sensitization using quantitative sensory testing: A focus on individuals with low back pain. Appl Nurs Res. 2016 Feb;29:237-41. doi: 10.1016/j.apnr.2015.03.013. Epub 2015 Apr 8.
  PMID: 26856520
  citation: Stevans JM, Delitto A, Khoja SS, Patterson CG, Smith CN, Schneider MJ, Freburger JK, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Friedman M, Beneciuk JM, George SZ, Saper RB. Risk Factors Associated With Transition From Acute to Chronic Low Back Pain in US Patients Seeking Primary Care. JAMA Netw Open. 2021 Feb 1;4(2):e2037371. doi: 10.1001/jamanetworkopen.2020.37371.
  PMID: 33591367
  citation: Strand LI, Moe-Nilssen R, Ljunggren AE. Back Performance Scale for the assessment of mobility-related activities in people with back pain. Phys Ther. 2002 Dec;82(12):1213-23.
  PMID: 12444880
  citation: Verdugo RJ, Matamala JM, Inui K, Kakigi R, Valls-Sole J, Hansson P, Nilsen KB, Lombardi R, Lauria G, Petropoulos IN, Malik RA, Treede RD, Baumgartner U, Jara PA, Campero M. Review of techniques useful for the assessment of sensory small fiber neuropathies: Report from an IFCN expert group. Clin Neurophysiol. 2022 Apr;136:13-38. doi: 10.1016/j.clinph.2022.01.002. Epub 2022 Jan 19.
  PMID: 35131635
  citation: Vlaeyen JWS, Crombez G, Linton SJ. The fear-avoidance model of pain. Pain. 2016 Aug;157(8):1588-1589. doi: 10.1097/j.pain.0000000000000574. No abstract available.
  PMID: 27428892
  citation: Wheeler CHB, Williams ACC, Morley SJ. Meta-analysis of the psychometric properties of the Pain Catastrophizing Scale and associations with participant characteristics. Pain. 2019 Sep;160(9):1946-1953. doi: 10.1097/j.pain.0000000000001494.
  PMID: 30694929
  citation: Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.
  PMID: 24402217
  citation: Denis I, Fortin L. Development of a French-Canadian version of the Oswestry Disability Index: cross-cultural adaptation and validation. Spine (Phila Pa 1976). 2012 Apr 1;37(7):E439-44. doi: 10.1097/BRS.0b013e318233eaf9.
  PMID: 22037523
  citation: Poquet N, Lin C. The Brief Pain Inventory (BPI). J Physiother. 2016 Jan;62(1):52. doi: 10.1016/j.jphys.2015.07.001. Epub 2015 Aug 21. No abstract available.
  PMID: 26303366
  responsible party type: Principal Investigator
  investigator affiliation: Université du Québec à Trois-Rivières
  investigator full name: Mathieu Piché
  investigator title: Professor
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: Yes
  ipd description: After publication of the results, the data that support the findings of this study will be available from the corresponding author, MP, upon reasonable request.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd time frame: Data will become available upon publication of the results (expected in January 2026). They will be available for the next 5 years.
  provided document: 