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/NCT06030128</url>
    </required_header>
    <id_info>
      <org_study_id>20230506002</org_study_id>
      <nct_id>NCT06030128</nct_id>
    </id_info>
    <brief_title>Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults</brief_title>
    <official_title>Core Stabilization Exercise Therapy in Chronic Lower Back Pain Management in Community Dwelling Older Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Hong Kong Polytechnic University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Hong Kong Polytechnic University</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>
        Objectives: To develop an exercise program for older adults with low back pain. And,to&#xD;
        develop a clinical prediction rule that could identify a subgroup of people with NSLBP&#xD;
  &#xD;
        Participants:&#xD;
  &#xD;
        150 people aged between 40 to 80 with non-specific low back pain (NSLBP) for more than 6&#xD;
        months and is able to ambulate independently will be invited to join the study. People who&#xD;
        had 1) previous spinal surgery; 2) LBP attributable to current pregnancy; 3) acute fracture,&#xD;
        recent fall, tumour, or bone infection; and 4) experience of practising core-stability&#xD;
        exercises in the past 6 months will be excluded. Study details will be explained to&#xD;
        participants and written consent will be obtained prior the study. 75 participants will be&#xD;
        randomized into the intervention group. Another 75 participants will be randomized into the&#xD;
        waiting list control group.&#xD;
  &#xD;
        Assessment Participants will undergo two comprehensive assessments before and after the&#xD;
        training, which includes: Surface electromyogram (EMG) on the lumbar spine and abdominal&#xD;
        muscle, Inertial measurement unit (IMU) sensor for trunk movement, clinical assessment&#xD;
        including. Prone instability test.&#xD;
  &#xD;
        Subjective assessments: Visual analogue scale score for pain, The Oswestry Low Back Pain&#xD;
        Disability Questionnaire and Roland-Morris Disability Questionnaire.&#xD;
  &#xD;
        Intervention - 16 session structured exercise program All participants will undergo a 16&#xD;
        session exercise program for 2 months. Each session will last for 60minutes. The exercise&#xD;
        program will be arranged in a group format with class size ranging from 6 - 8 per class&#xD;
        Subjects will be divided into experimental and control groups. Participants in the control&#xD;
        group will not receive exercise training at first but were evaluated at the same time as&#xD;
        participants in the experimental group. The participant in the control group completed the&#xD;
        exercise training after the post-assessment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        People with non-specific low back pain (NSLBP) demonstrate diversified clinical signs and&#xD;
        symptoms. It is because the cause of NSLBP is multifaceted. Due to the varied pathophysiology&#xD;
        and clinical behavior, the 'one-suit-all' approach of physiotherapy treatment prescription&#xD;
        for people with NSLBP is usually less effective in reducing pain and improving daily&#xD;
        function.&#xD;
  &#xD;
        Research on identifying subgroups of patients with NSLBP who would benefit from physiotherapy&#xD;
        interventions could provide clinicians evidence-based guidelines and enhance the&#xD;
        cost-effectiveness of health care service. Earlier research showed that people with NSLBP&#xD;
        demonstrated a delay in core muscle activation and general wasting of the trunk and core&#xD;
        muscle. These pathological changes support the use of core stability training (e.g., Pilates&#xD;
        exercise) to manage people with NSLBP. However, effectiveness of core stability training have&#xD;
        not been studied extensively in older adults.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 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>
      <intervention_model_description>75 participants will be randomized into the intervention group. Another 75 participants will be randomized into the waiting list control group.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Oswestry Low Back Pain Disability Questionnaire</measure>
      <time_frame>pre-intervention session (T1)</time_frame>
      <description>is a widely used questionnaire designed to assess the level of disability and functional impairment in individuals with lower back pain. The questionnaire consists of 10 sections, each focusing on a different aspect of daily living that might be affected by back pain, such as personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling.&#xD;
  Each section is scored on a scale of 0 to 5, with higher scores indicating greater disability. The scores for all sections are then summed and converted to a percentage, which can range from 0% (no disability) to 100% (maximum disability).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Oswestry Low Back Pain Disability Questionnaire</measure>
      <time_frame>post-intervention (8 weeks after start of intervention;T2)</time_frame>
      <description>is a widely used questionnaire designed to assess the level of disability and functional impairment in individuals with lower back pain. The questionnaire consists of 10 sections, each focusing on a different aspect of daily living that might be affected by back pain, such as personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling.&#xD;
  Each section is scored on a scale of 0 to 5, with higher scores indicating greater disability. The scores for all sections are then summed and converted to a percentage, which can range from 0% (no disability) to 100% (maximum disability).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale (VAS) score for pain</measure>
      <time_frame>pre-intervention session (T1)</time_frame>
      <description>The Visual Analogue Scale (VAS) is a tool commonly used to measure a person's pain intensity. The scale typically consists of a 10cm horizontal line. Anchored by two verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most often anchored by &quot;No Pain&quot; at one end and &quot;Worst Imaginable Pain&quot; at the other.&#xD;
  Patients are asked to mark a point along the line that represents their current level of pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale (VAS) score for pain</measure>
      <time_frame>post-intervention (8 weeks after start of intervention;T2)</time_frame>
      <description>The Visual Analogue Scale (VAS) is a tool commonly used to measure a person's pain intensity. The scale typically consists of a 10cm horizontal line. Anchored by two verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most often anchored by &quot;No Pain&quot; at one end and &quot;Worst Imaginable Pain&quot; at the other.&#xD;
  Patients are asked to mark a point along the line that represents their current level of pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fear-Avoidance Belief Questionnaire</measure>
      <time_frame>pre-intervention session (T1)</time_frame>
      <description>Participants finish the questionnaire with the help of investigators to assess how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability.&#xD;
  The scale score range from 0 - 96, a higher score indicates a higher level of fear avoidance beliefs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fear-Avoidance Belief Questionnaire</measure>
      <time_frame>post-intervention (8 weeks after start of intervention;T2)</time_frame>
      <description>Participants finish the questionnaire with the help of investigators to assess how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability.&#xD;
  The scale score range from 0 - 96, a higher score indicates a higher level of fear avoidance beliefs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surface EMG</measure>
      <time_frame>pre-intervention session (T1)</time_frame>
      <description>EMG-sensors attached to the skin overlying the erector spinae at the T4 vertebrae (approximately 2-3 cm from the midline of the back) on both sides.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surface EMG</measure>
      <time_frame>post-intervention (8 weeks after start of intervention;T2)</time_frame>
      <description>EMG-sensors attached to the skin overlying the erector spinae at the T4 vertebrae (approximately 2-3 cm from the midline of the back) on both sides.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>IMU-sensor</measure>
      <time_frame>pre-intervention session (T1)</time_frame>
      <description>IMU-sensors attached to the skin overlying the erector spinae at the T3 and L1 vertebrae(approximately 3-4 cm from the midline of the back), Pelvis(S2) and femur. IMU-sensors were positioned unilaterally on the right side.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>IMU-sensor</measure>
      <time_frame>post-intervention (8 weeks after start of intervention;T2)</time_frame>
      <description>IMU-sensors attached to the skin overlying the erector spinae at the T3 and L1 vertebrae(approximately 3-4 cm from the midline of the back), Pelvis(S2) and femur. IMU-sensors were positioned unilaterally on the right side.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prone instability test</measure>
      <time_frame>pre-intervention session (T1)</time_frame>
      <description>Participants will assume a face-down position on a bench, allowing their legs to dangle off the edge so that their feet touch the ground. Manual pressure will then be applied on various lumbar spine segments to induce pain. If pain occurs, participants then raise their legs off the ground before the application of back-to-front pressure is repeated. A reduction in pain when lifting the legs indicates the ability to actively stabilize the spine, signifying a positive test result. In such cases, a stability-focused exercise regimen would be appropriate for the individual.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prone instability test</measure>
      <time_frame>post-intervention (8 weeks after start of intervention;T2)</time_frame>
      <description>Participants will assume a face-down position on a bench, allowing their legs to dangle off the edge so that their feet touch the ground. Manual pressure will then be applied on various lumbar spine segments to induce pain. If pain occurs, participants then raise their legs off the ground before the application of back-to-front pressure is repeated. A reduction in pain when lifting the legs indicates the ability to actively stabilize the spine, signifying a positive test result. In such cases, a stability-focused exercise regimen would be appropriate for the individual.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>straight leg raise (SLR)</measure>
      <time_frame>pre-intervention session (T1)</time_frame>
      <description>The Straight Leg Raise (SLR) test is a commonly used diagnostic procedure to evaluate for the presence of lumbar radiculopathy, often caused by a herniated disc. During the test, the patient lies flat on their back on an examination table. The examiner then lifts one of the patient's straightened legs by the ankle, keeping the knee extended.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>straight leg raise (SLR)</measure>
      <time_frame>post-intervention (8 weeks after start of intervention;T2)</time_frame>
      <description>The Straight Leg Raise (SLR) test is a commonly used diagnostic procedure to evaluate for the presence of lumbar radiculopathy, often caused by a herniated disc. During the test, the patient lies flat on their back on an examination table. The examiner then lifts one of the patient's straightened legs by the ankle, keeping the knee extended</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>internal rotation range of motion</measure>
      <time_frame>pre-intervention session (T1)</time_frame>
      <description>When the knee is in a position of flexion between 30 and 90 degrees, there are approximately 45 degrees external and 25 degrees internal rotation. Rotatory motion decreases with further extension and, at 5 degrees of flexion, the knee has 23 degrees external and 10 degrees internal rotation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>internal rotation range of motion</measure>
      <time_frame>post-intervention (8 weeks after start of intervention;T2)</time_frame>
      <description>When the knee is in a position of flexion between 30 and 90 degrees, there are approximately 45 degrees external and 25 degrees internal rotation. Rotatory motion decreases with further extension and, at 5 degrees of flexion, the knee has 23 degrees external and 10 degrees internal rotation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FABER test</measure>
      <time_frame>pre-intervention session (T1)</time_frame>
      <description>The FABER test is used to identify the presence of hip pathology by attempting to reproduce pain in the hip, lumbar spine or sacroiliac region. The test is a passive screening tool for musculoskeletal pathologies, such as hip, lumbar spine, or sacroiliac joint dysfunction, or an iliopsoas spasm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FABER test</measure>
      <time_frame>post-intervention (8 weeks after start of intervention;T2)</time_frame>
      <description>The FABER test is used to identify the presence of hip pathology by attempting to reproduce pain in the hip, lumbar spine or sacroiliac region. The test is a passive screening tool for musculoskeletal pathologies, such as hip, lumbar spine, or sacroiliac joint dysfunction, or an iliopsoas spasm.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Chronic Low-back Pain</condition>
    <condition>Older Adults</condition>
    <condition>Core Stabilization Exercise Therapy</condition>
    <arm_group>
      <arm_group_label>Core stabilization exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants will undergo 16 session exercise program for 2 months. Each session will last for 60minutes. The exercise program will be arranged in a group format with class size ranging from 6 - 8per class. Subjects will be divided into experimental and control groups.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>waiting list control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in the control group will not receive exercise training at first but were evaluated at the same time as participants in the experimental group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>core stabilization exercise</intervention_name>
      <description>All participants will undergo a 16 session exercise program for 2 months. Each session will last for 60minutes. The exercise program will be arranged in a group format with class size ranging from 6-8 per class. Subjects will be divided into experimental and control groups.</description>
      <arm_group_label>Core stabilization exercise group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1）people aged between 40 to 80 with non-specific low back pain (NSLBP) for more than 6&#xD;
               months ；2）people is able to ambulate independently&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1) previous spinal surgery; 2) LBP attributable to current pregnancy; 3) acute&#xD;
               fracture, recent fall, tumour, or bone infection; and 4) experience of practising&#xD;
               core-stability exercises in the past 6 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Patrick Kwong, PhD</last_name>
      <phone>852-62353459</phone>
      <email>whkwong@polyu.edu.hk</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Hong Kong Polytechnic University</name>
        <address>
          <city>Hong Kong</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gladys Cheing, PhD</last_name>
        <phone>27666738</phone>
        <email>gladys.cheing@polyu.edu.hk</email>
      </contact>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <reference>
      <citation>Lee JH, Hoshino Y, Nakamura K, Kariya Y, Saita K, Ito K. Trunk muscle weakness as a risk factor for low back pain. A 5-year prospective study. Spine (Phila Pa 1976). 1999 Jan 1;24(1):54-7. doi: 10.1097/00007632-199901010-00013.</citation>
      <PMID>9921591</PMID>
    </reference>
    <reference>
      <citation>Kato S, Murakami H, Demura S, Yoshioka K, Shinmura K, Yokogawa N, Igarashi T, Yonezawa N, Shimizu T, Tsuchiya H. Abdominal trunk muscle weakness and its association with chronic low back pain and risk of falling in older women. BMC Musculoskelet Disord. 2019 Jun 3;20(1):273. doi: 10.1186/s12891-019-2655-4.</citation>
      <PMID>31159812</PMID>
    </reference>
    <reference>
      <citation>Arendt-Nielsen L, Graven-Nielsen T, Svarrer H, Svensson P. The influence of low back pain on muscle activity and coordination during gait: a clinical and experimental study. Pain. 1996 Feb;64(2):231-240. doi: 10.1016/0304-3959(95)00115-8.</citation>
      <PMID>8740599</PMID>
    </reference>
    <reference>
      <citation>Lamoth CJ, Meijer OG, Daffertshofer A, Wuisman PI, Beek PJ. Effects of chronic low back pain on trunk coordination and back muscle activity during walking: changes in motor control. Eur Spine J. 2006 Jan;15(1):23-40. doi: 10.1007/s00586-004-0825-y. Epub 2005 Apr 29.</citation>
      <PMID>15864670</PMID>
    </reference>
    <reference>
      <citation>Walter BA, Mageswaran P, Mo X, Boulter DJ, Mashaly H, Nguyen XV, Prevedello LM, Thoman W, Raterman BD, Kalra P, Mendel E, Marras WS, Kolipaka A. MR Elastography-derived Stiffness: A Biomarker for Intervertebral Disc Degeneration. Radiology. 2017 Oct;285(1):167-175. doi: 10.1148/radiol.2017162287. Epub 2017 May 4.</citation>
      <PMID>28471737</PMID>
    </reference>
    <reference>
      <citation>Roussel NA, Nijs J, Meeus M, Mylius V, Fayt C, Oostendorp R. Central sensitization and altered central pain processing in chronic low back pain: fact or myth? Clin J Pain. 2013 Jul;29(7):625-38. doi: 10.1097/AJP.0b013e31826f9a71.</citation>
      <PMID>23739534</PMID>
    </reference>
    <reference>
      <citation>Nakamura M, Nishiwaki Y, Sumitani M, Ushida T, Yamashita T, Konno S, Taguchi T, Toyama Y. Investigation of chronic musculoskeletal pain (third report): with special reference to the importance of neuropathic pain and psychogenic pain. J Orthop Sci. 2014 Jul;19(4):667-75. doi: 10.1007/s00776-014-0567-6. Epub 2014 Apr 16.</citation>
      <PMID>24737064</PMID>
    </reference>
    <reference>
      <citation>Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain. A meta-analysis of effectiveness relative to other therapies. Ann Intern Med. 2003 Jun 3;138(11):871-81. doi: 10.7326/0003-4819-138-11-200306030-00008.</citation>
      <PMID>12779297</PMID>
    </reference>
    <reference>
      <citation>Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.</citation>
      <PMID>15867409</PMID>
    </reference>
    <reference>
      <citation>Fritz JM, Lindsay W, Matheson JW, Brennan GP, Hunter SJ, Moffit SD, Swalberg A, Rodriquez B. Is there a subgroup of patients with low back pain likely to benefit from mechanical traction? Results of a randomized clinical trial and subgrouping analysis. Spine (Phila Pa 1976). 2007 Dec 15;32(26):E793-800. doi: 10.1097/BRS.0b013e31815d001a.</citation>
      <PMID>18091473</PMID>
    </reference>
    <reference>
      <citation>Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.</citation>
      <PMID>16181938</PMID>
    </reference>
    <reference>
      <citation>Cooper RG, St Clair Forbes W, Jayson MI. Radiographic demonstration of paraspinal muscle wasting in patients with chronic low back pain. Br J Rheumatol. 1992 Jun;31(6):389-94. doi: 10.1093/rheumatology/31.6.389.</citation>
      <PMID>1534505</PMID>
    </reference>
    <reference>
      <citation>Danneels LA, Vanderstraeten GG, Cambier DC, Witvrouw EE, De Cuyper HJ. CT imaging of trunk muscles in chronic low back pain patients and healthy control subjects. Eur Spine J. 2000 Aug;9(4):266-72. doi: 10.1007/s005860000190.</citation>
      <PMID>11261613</PMID>
    </reference>
    <reference>
      <citation>Ravenna MM, Hoffman SL, Van Dillen LR. Low interrater reliability of examiners performing the prone instability test: a clinical test for lumbar shear instability. Arch Phys Med Rehabil. 2011 Jun;92(6):913-9. doi: 10.1016/j.apmr.2010.12.042.</citation>
      <PMID>21621668</PMID>
    </reference>
    <reference>
      <citation>Luomajoki H, Kool J, de Bruin ED, Airaksinen O. Reliability of movement control tests in the lumbar spine. BMC Musculoskelet Disord. 2007 Sep 12;8:90. doi: 10.1186/1471-2474-8-90.</citation>
      <PMID>17850669</PMID>
    </reference>
    <reference>
      <citation>Lue YJ, Hsieh CL, Huang MH, Lin GT, Lu YM. Development of a Chinese version of the Oswestry Disability Index version 2.1. Spine (Phila Pa 1976). 2008 Oct 1;33(21):2354-60. doi: 10.1097/BRS.0b013e31818018d8.</citation>
      <PMID>18827702</PMID>
    </reference>
    <reference>
      <citation>Aladro-Gonzalvo AR, Araya-Vargas GA, Machado-Diaz M, Salazar-Rojas W. Pilates-based exercise for persistent, non-specific low back pain and associated functional disability: a meta-analysis with meta-regression. J Bodyw Mov Ther. 2013 Jan;17(1):125-36. doi: 10.1016/j.jbmt.2012.08.003. Epub 2012 Sep 16.</citation>
      <PMID>23294694</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
      <investigator_full_name>Dr Patrick Kwong</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <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>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06030128
  org study id: 20230506002
  nct id: NCT06030128
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objectives: To develop an exercise program for older adults with low back pain. And,to
        develop a clinical prediction rule that could identify a subgroup of people with NSLBP
  
        Participants:
  
        150 people aged between 40 to 80 with non-specific low back pain (NSLBP) for more than 6
        months and is able to ambulate independently will be invited to join the study. People who
        had 1) previous spinal surgery; 2) LBP attributable to current pregnancy; 3) acute fracture,
        recent fall, tumour, or bone infection; and 4) experience of practising core-stability
        exercises in the past 6 months will be excluded. Study details will be explained to
        participants and written consent will be obtained prior the study. 75 participants will be
        randomized into the intervention group. Another 75 participants will be randomized into the
        waiting list control group.
  
        Assessment Participants will undergo two comprehensive assessments before and after the
        training, which includes: Surface electromyogram (EMG) on the lumbar spine and abdominal
        muscle, Inertial measurement unit (IMU) sensor for trunk movement, clinical assessment
        including. Prone instability test.
  
        Subjective assessments: Visual analogue scale score for pain, The Oswestry Low Back Pain
        Disability Questionnaire and Roland-Morris Disability Questionnaire.
  
        Intervention - 16 session structured exercise program All participants will undergo a 16
        session exercise program for 2 months. Each session will last for 60minutes. The exercise
        program will be arranged in a group format with class size ranging from 6 - 8 per class
        Subjects will be divided into experimental and control groups. Participants in the control
        group will not receive exercise training at first but were evaluated at the same time as
        participants in the experimental group. The participant in the control group completed the
        exercise training after the post-assessment.
  People with non-specific low back pain (NSLBP) demonstrate diversified clinical signs and
        symptoms. It is because the cause of NSLBP is multifaceted. Due to the varied pathophysiology
        and clinical behavior, the 'one-suit-all' approach of physiotherapy treatment prescription
        for people with NSLBP is usually less effective in reducing pain and improving daily
        function.
  
        Research on identifying subgroups of patients with NSLBP who would benefit from physiotherapy
        interventions could provide clinicians evidence-based guidelines and enhance the
        cost-effectiveness of health care service. Earlier research showed that people with NSLBP
        demonstrated a delay in core muscle activation and general wasting of the trunk and core
        muscle. These pathological changes support the use of core stability training (e.g., Pilates
        exercise) to manage people with NSLBP. However, effectiveness of core stability training have
        not been studied extensively in older adults.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 75 participants will be randomized into the intervention group. Another 75 participants will be randomized into the waiting list control group.
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: The Oswestry Low Back Pain Disability Questionnaire
  time frame: pre-intervention session (T1)
  description: is a widely used questionnaire designed to assess the level of disability and functional impairment in individuals with lower back pain. The questionnaire consists of 10 sections, each focusing on a different aspect of daily living that might be affected by back pain, such as personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling.
  Each section is scored on a scale of 0 to 5, with higher scores indicating greater disability. The scores for all sections are then summed and converted to a percentage, which can range from 0% (no disability) to 100% (maximum disability).
  measure: The Oswestry Low Back Pain Disability Questionnaire
  time frame: post-intervention (8 weeks after start of intervention;T2)
  description: is a widely used questionnaire designed to assess the level of disability and functional impairment in individuals with lower back pain. The questionnaire consists of 10 sections, each focusing on a different aspect of daily living that might be affected by back pain, such as personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling.
  Each section is scored on a scale of 0 to 5, with higher scores indicating greater disability. The scores for all sections are then summed and converted to a percentage, which can range from 0% (no disability) to 100% (maximum disability).
  measure: Visual analogue scale (VAS) score for pain
  time frame: pre-intervention session (T1)
  description: The Visual Analogue Scale (VAS) is a tool commonly used to measure a person's pain intensity. The scale typically consists of a 10cm horizontal line. Anchored by two verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most often anchored by "No Pain" at one end and "Worst Imaginable Pain" at the other.
  Patients are asked to mark a point along the line that represents their current level of pain.
  measure: Visual analogue scale (VAS) score for pain
  time frame: post-intervention (8 weeks after start of intervention;T2)
  description: The Visual Analogue Scale (VAS) is a tool commonly used to measure a person's pain intensity. The scale typically consists of a 10cm horizontal line. Anchored by two verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most often anchored by "No Pain" at one end and "Worst Imaginable Pain" at the other.
  Patients are asked to mark a point along the line that represents their current level of pain.
  measure: Fear-Avoidance Belief Questionnaire
  time frame: pre-intervention session (T1)
  description: Participants finish the questionnaire with the help of investigators to assess how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability.
  The scale score range from 0 - 96, a higher score indicates a higher level of fear avoidance beliefs.
  measure: Fear-Avoidance Belief Questionnaire
  time frame: post-intervention (8 weeks after start of intervention;T2)
  description: Participants finish the questionnaire with the help of investigators to assess how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability.
  The scale score range from 0 - 96, a higher score indicates a higher level of fear avoidance beliefs.
  measure: Surface EMG
  time frame: pre-intervention session (T1)
  description: EMG-sensors attached to the skin overlying the erector spinae at the T4 vertebrae (approximately 2-3 cm from the midline of the back) on both sides.
  measure: Surface EMG
  time frame: post-intervention (8 weeks after start of intervention;T2)
  description: EMG-sensors attached to the skin overlying the erector spinae at the T4 vertebrae (approximately 2-3 cm from the midline of the back) on both sides.
  measure: IMU-sensor
  time frame: pre-intervention session (T1)
  description: IMU-sensors attached to the skin overlying the erector spinae at the T3 and L1 vertebrae(approximately 3-4 cm from the midline of the back), Pelvis(S2) and femur. IMU-sensors were positioned unilaterally on the right side.
  measure: IMU-sensor
  time frame: post-intervention (8 weeks after start of intervention;T2)
  description: IMU-sensors attached to the skin overlying the erector spinae at the T3 and L1 vertebrae(approximately 3-4 cm from the midline of the back), Pelvis(S2) and femur. IMU-sensors were positioned unilaterally on the right side.
  measure: Prone instability test
  time frame: pre-intervention session (T1)
  description: Participants will assume a face-down position on a bench, allowing their legs to dangle off the edge so that their feet touch the ground. Manual pressure will then be applied on various lumbar spine segments to induce pain. If pain occurs, participants then raise their legs off the ground before the application of back-to-front pressure is repeated. A reduction in pain when lifting the legs indicates the ability to actively stabilize the spine, signifying a positive test result. In such cases, a stability-focused exercise regimen would be appropriate for the individual.
  measure: Prone instability test
  time frame: post-intervention (8 weeks after start of intervention;T2)
  description: Participants will assume a face-down position on a bench, allowing their legs to dangle off the edge so that their feet touch the ground. Manual pressure will then be applied on various lumbar spine segments to induce pain. If pain occurs, participants then raise their legs off the ground before the application of back-to-front pressure is repeated. A reduction in pain when lifting the legs indicates the ability to actively stabilize the spine, signifying a positive test result. In such cases, a stability-focused exercise regimen would be appropriate for the individual.
  measure: straight leg raise (SLR)
  time frame: pre-intervention session (T1)
  description: The Straight Leg Raise (SLR) test is a commonly used diagnostic procedure to evaluate for the presence of lumbar radiculopathy, often caused by a herniated disc. During the test, the patient lies flat on their back on an examination table. The examiner then lifts one of the patient's straightened legs by the ankle, keeping the knee extended.
  measure: straight leg raise (SLR)
  time frame: post-intervention (8 weeks after start of intervention;T2)
  description: The Straight Leg Raise (SLR) test is a commonly used diagnostic procedure to evaluate for the presence of lumbar radiculopathy, often caused by a herniated disc. During the test, the patient lies flat on their back on an examination table. The examiner then lifts one of the patient's straightened legs by the ankle, keeping the knee extended
  measure: internal rotation range of motion
  time frame: pre-intervention session (T1)
  description: When the knee is in a position of flexion between 30 and 90 degrees, there are approximately 45 degrees external and 25 degrees internal rotation. Rotatory motion decreases with further extension and, at 5 degrees of flexion, the knee has 23 degrees external and 10 degrees internal rotation.
  measure: internal rotation range of motion
  time frame: post-intervention (8 weeks after start of intervention;T2)
  description: When the knee is in a position of flexion between 30 and 90 degrees, there are approximately 45 degrees external and 25 degrees internal rotation. Rotatory motion decreases with further extension and, at 5 degrees of flexion, the knee has 23 degrees external and 10 degrees internal rotation.
  measure: FABER test
  time frame: pre-intervention session (T1)
  description: The FABER test is used to identify the presence of hip pathology by attempting to reproduce pain in the hip, lumbar spine or sacroiliac region. The test is a passive screening tool for musculoskeletal pathologies, such as hip, lumbar spine, or sacroiliac joint dysfunction, or an iliopsoas spasm.
  measure: FABER test
  time frame: post-intervention (8 weeks after start of intervention;T2)
  description: The FABER test is used to identify the presence of hip pathology by attempting to reproduce pain in the hip, lumbar spine or sacroiliac region. The test is a passive screening tool for musculoskeletal pathologies, such as hip, lumbar spine, or sacroiliac joint dysfunction, or an iliopsoas spasm.
  arm group label: Core stabilization exercise group
  arm group type: Experimental
  description: All participants will undergo 16 session exercise program for 2 months. Each session will last for 60minutes. The exercise program will be arranged in a group format with class size ranging from 6 - 8per class. Subjects will be divided into experimental and control groups.
  arm group label: waiting list control group
  arm group type: No Intervention
  description: Participants in the control group will not receive exercise training at first but were evaluated at the same time as participants in the experimental group.
  intervention type: Behavioral
  intervention name: core stabilization exercise
  description: All participants will undergo a 16 session exercise program for 2 months. Each session will last for 60minutes. The exercise program will be arranged in a group format with class size ranging from 6-8 per class. Subjects will be divided into experimental and control groups.
  arm group label: Core stabilization exercise group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Patrick Kwong, PhD
  phone: 852-62353459
  email: whkwong@polyu.edu.hk
  facility: 
  status: Recruiting
  contact: 
  country: Hong Kong
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  PMID: 23294694
  responsible party type: Principal Investigator
  investigator affiliation: The Hong Kong Polytechnic University
  investigator full name: Dr Patrick Kwong
  investigator title: Assistant Professor
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: Undecided