<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/NCT03022812</url>
  </required_header>
  <id_info>
    <org_study_id>2016/135-31</org_study_id>
    <nct_id>NCT03022812</nct_id>
  </id_info>
  <brief_title>Neck-specific Exercise in Chronic Whiplash</brief_title>
  <official_title>Is E-health a Way to Increase Ability and Health and Make Health Care More Effective in Chronic Whiplash? A Prospective Randomized Controlled Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Linkoeping 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>
      Neck pain is fourth among the most common conditions worldwide associated with longer periods&#xD;
      of living with disability. Annually, about 30 000 people in Sweden undergo a whiplash trauma&#xD;
      (WAD), and half of those individuals will develop chronic problems with high costs for the&#xD;
      individual and society. Evidence for chronic WAD treatment is scarce, although neck-specific&#xD;
      training at a physiotherapy clinic (2 times a week for 3 months) has demonstrated good&#xD;
      results. A more efficient, flexible rehabilitation with reduced waiting times and lower costs&#xD;
      is needed, ideally replacing lengthy on-site treatment series by health care providers.&#xD;
      Internet-based care has proven to be a viable alternative to personal care meetings for a&#xD;
      variety of diseases and interventions, but studies are lacking on Internet-based&#xD;
      interventions for individuals with chronic neck problems. The purpose of this study is to&#xD;
      investigate if A) neck-specific training delivered through Internet-based care differs from&#xD;
      B) a longer series of treatments at a physiotherapy clinic regarding, e.g., work ability,&#xD;
      sick-leave and disability. This prospective, randomized study involves 140 participants.&#xD;
      Measurement is done at baseline, 3 months (end of treatment), and 15 months (12 months after&#xD;
      end of treatment in the study) and will include ratings of work ability, sick-leave, work&#xD;
      presenteeism, disability, pain, health, satisfaction with care, quality of life, and&#xD;
      cost-effectiveness. The study results may contribute to the development of a more effective&#xD;
      rehabilitation, flexible and equal care, shorter waiting times, increased availability and&#xD;
      lower costs for health care and society. The program can be implemented on a broader scale in&#xD;
      neck pain patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to investigate if the effect of neck-specific exercises in people&#xD;
      with chronic WAD (at risk for or at sick-leave) differs based on distribution via&#xD;
      Internet-based care in combination with three visits (+ a first examination visit due to&#xD;
      Swedish law) to the physiotherapist compared to a longer series (2 times/week for 3 months,&#xD;
      i.e., 24 times + a first visit) of exercises at the physiotherapy clinic. Outcomes are for&#xD;
      instance work ability, sick-leave, physical and psychological disability, pain, quality of&#xD;
      life, satisfaction with treatment, and cost effectiveness. Further objectives are to a)&#xD;
      describe the level of work ability, work presenteeism, and sick leave; b) determine which&#xD;
      factors are related to a good work ability; c) identify factors predictive of a favourable&#xD;
      outcome regarding work ability, disability, and pain; and d) describe how the participants&#xD;
      perceived an Internet-based rehabilitation.&#xD;
&#xD;
      Hypothesis: Internet-based support combined with a few (three) physiotherapist visits has an&#xD;
      equivalent effect to a longer exercise period (24 times) at a physiotherapist clinic and&#xD;
      yields lower economic costs for society.&#xD;
&#xD;
      Design This is an experimental, longitudinal, prospective, multicentre randomized controlled&#xD;
      trial (RCT) with two treatment arms. Treatment that has previously been shown to be effective&#xD;
      (neck-specific exercises guided by a physiotherapist and performed at the physiotherapist&#xD;
      clinic) for the current population constitutes the control treatment for the new&#xD;
      Internet-based neck-specific exercise treatment. A total of 140 people are expected to be&#xD;
      included, 70 in each group (sample size estimated by statisticians). Independent&#xD;
      physiotherapists in primary care clinical practice will distribute the treatment. The project&#xD;
      manager will not be a test leader.&#xD;
&#xD;
      Recruitment and randomization Interested patients will contact the research team (experienced&#xD;
      physiotherapists), and after a small survey filled in by the potential participant, a project&#xD;
      team member will perform a telephone interview, ask about the medical history, and perform a&#xD;
      physical examination to ensure that criteria for study participation are met. If the study&#xD;
      criteria are met and after written and oral informed consent of the patient, the patient will&#xD;
      fill out a questionnaire (baseline data) and undergo physical measurements of neck-related&#xD;
      function. Baseline measurements must be completed for inclusion.&#xD;
&#xD;
      The patient will be randomized through a computerized randomization list (block randomization&#xD;
      conducted by a statistician, stratification by gender) to one of two groups of 3 months of&#xD;
      treatment with neck-specific exercises: A) exercises at a physiotherapy clinic 2 times/week&#xD;
      for 3 months; or B) Internet-based support exercises in combination with four visits to the&#xD;
      physiotherapist. The test leader is blinded for group allocation. The randomization is&#xD;
      performed by an independent researcher not otherwise involved in any of the test or&#xD;
      treatments. The researcher sends an opaque envelope containing the name and contact details&#xD;
      of the patient and information about the randomization group to the treating physiotherapist,&#xD;
      who calls the patient to a new clinical examination (by law) before treatment can start. Due&#xD;
      to the nature of the study neither participants nor treating therapists can be blinded,&#xD;
      however all tests are done by blinded test leaders. Data collection in the form of&#xD;
      questionnaires and tests of physical neck-related function occurs at baseline (before&#xD;
      randomization) and after 3 months (when the treatment ends) and 15 months (12 months after&#xD;
      completion of the intervention in the project). The treating physiotherapists will receive&#xD;
      oral and written information and a day of practical training. The treating physiotherapist is&#xD;
      also able to consult with the project managers at any time if necessary. An exercise diary is&#xD;
      maintained by patients in both groups, and the number of care contacts is recorded by the&#xD;
      physiotherapist. Seventy people per group, i.e., a total of 140 participants with chronic WAD&#xD;
      grades 2 and 3, will be recruited.&#xD;
&#xD;
      Intervention Group A, neck-specific exercises at a physiotherapy clinic: Participants get an&#xD;
      explanation and justification for the exercise. They undergo a 12-week training program with&#xD;
      a physiotherapist 2 times/week. Exercises are chosen from a clear and written frame of&#xD;
      exercises, although the dosages are individually adapted. The training includes exercises&#xD;
      activating the deep neck muscles, continuing with the endurance training of neck and shoulder&#xD;
      muscles. The exercises are individually adjusted according to the individual's physical&#xD;
      conditions and progressively increased in severity and dose. Exercise-related pain&#xD;
      provocation is not accepted. The individual may also carry out home exercises. At the end of&#xD;
      the treatment period, the patient is encouraged to continue practicing on their own.&#xD;
&#xD;
      Group B, neck-specific exercises with Internet support: Participants receive the same&#xD;
      information and training programs as group A but have in total only four visits (a first&#xD;
      examination visit and additional three visits) to the physiotherapist. When the exercises are&#xD;
      introduced, they are repeated, and control is done so that the patient has understood how to&#xD;
      conduct the exercises. The exercises take place, with the help of Internet support outside&#xD;
      the health care system, probably mostly at home. Photos and videos of the exercises,&#xD;
      information, and answers to frequently asked questions are available on the Internet&#xD;
      (web-based system designed by the project leaders at the University). Patients can contact a&#xD;
      physiotherapist if necessary, and can normally expect an answer within 3 days.&#xD;
&#xD;
      Any important harms or unintended effects in each group will be collected by the test&#xD;
      leaders.&#xD;
&#xD;
      Sample size Sample size calculations in the study regarding group differences are calculated&#xD;
      by a statistician (non-inferiority trial, an assumption that treatment B is not worse than&#xD;
      A), and power is calculated by the software &quot;G-POWER&quot; and is based on the primary outcome&#xD;
      measurements WAI and NDI. Regarding WAI, it is considered important that the participants&#xD;
      improve from poor to moderate work ability, i.e., an average of 6 increments in a scale 7-47&#xD;
      (can also be classified into four groups: poor, moderate, good, and excellent). With a&#xD;
      significance level of 5% and a power of 80%, seven people in each classification group are&#xD;
      required. To get seven people in the &quot;poor group&quot; requires 60 people in total. To detect a&#xD;
      clinically relevant improvement in NDI of 7%, 47 participants per group are needed on the&#xD;
      basis of 80% power at a significance level of 5%. This value is based on the standard&#xD;
      deviation (SD 13.4) in the NDI in a previous study on neck-specific exercises of individuals&#xD;
      with chronic WAD grades 2 and 3. To ensure that enough people are in each group after&#xD;
      drop-outs, for prediction analyses, and some possibility for subgroup analyses (e.g., WAD&#xD;
      grades 2 and 3 or between men and women), the recommendation from the statistician was to&#xD;
      include 70 people/group.&#xD;
&#xD;
      Ethical considerations The study was approved by the regional ethical review board (Linköping&#xD;
      Dnr 2016 / 135-31). A previous clinical study relating to three different exercise&#xD;
      interventions on long-term problems after whiplash injury demonstrated good efficacy of&#xD;
      neck-specific exercise performed in primary health care. Current treatment is according to&#xD;
      the best scientific evidence, and exercises used in the present study have been used in daily&#xD;
      clinical practice for decades in the rehabilitation of various forms of neck pain.&#xD;
      Participants are included after a thorough clinical examination and signed informed (oral and&#xD;
      written information) consent. The exercises are adjusted individually. A risk of muscle&#xD;
      soreness is present, but otherwise no negative side effects are to be expected.&#xD;
&#xD;
      Login is required to fill in Internet-based surveys and to gain access to the Internet-based&#xD;
      exercise program. People with long-term problems often have low access to assessments and&#xD;
      treatments as more acute conditions often are prioritized in the health care system. Both&#xD;
      groups in the present study get active care that is expected to increase work ability. The&#xD;
      benefit is deemed to be great, and there are no commercial interests.&#xD;
&#xD;
      The results will be presented at group level, and no connection to the individual person can&#xD;
      be made. All data are anonymous and subject to the official health secrets act.&#xD;
&#xD;
      Statistical analysis Analyses will be done with parametric or non-parametric statistics,&#xD;
      depending on the type of data and if the analysis is between groups or over time. Analyses&#xD;
      will primarily be made on an intention-to-treat basis and as secondary as per protocol&#xD;
      analysis. When suitable a linear mixed model analysis will be used. For prediction analysis,&#xD;
      multivariate analysis will be performed. For calculation of cost-effectiveness,&#xD;
      quality-adjusted life-years and incremental cost-effective ratios will be calculated.&#xD;
&#xD;
      Sub-group analyses regarding gender, WAD grade, neurology, headache, dizziness and compliance&#xD;
      may be done.&#xD;
&#xD;
      Ultrasound registrations, electromyopgraphy, Magnetic Resonance Imaging and kinesthesia may&#xD;
      be done on a sub-group of participants to investigate neck muscle structure and function.&#xD;
      Interviews may be performed on a sub group of individuals to investigate the experience of&#xD;
      function and study participation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 6, 2017</start_date>
  <completion_date type="Actual">September 15, 2020</completion_date>
  <primary_completion_date type="Actual">September 15, 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neck Disability Index (NDI)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Self-reported neck-specific function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Whiplash Disability Questionnaire</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Disability associated with whiplash</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-specific functional scale (PSFS)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Individual ratings of function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity in neck, head, and arm and dizziness by a VAS (0-100 mm)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Pain intensity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of pain by a pain drawing assessed with images</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Distribution of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of pain</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Frequency of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of pain medications</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Use of pain medications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness/balance by the Dizziness Handicap Inventory (DHI)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Dizziness questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Questions by VAS and the Headache Impact Test (HIT-6)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Impact of headache</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing Scale</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Self-reported pain catastrophizing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQuol five dimensions</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Self-reported health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effort Reward Imbalance questionnaire</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Work related balance between effort and reward</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms Satisfaction scale</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Satisfaction with present symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity score, a combination score of the 2 questions (everyday physical activity and exercise/sport/open-air activity) to a combined 4-point score</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care consumption, number of visits</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Health care consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy Scale (SES)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Self-reported self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear Avoidance Beliefs Questionnaire (FABQ)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Fear Avoidance Beliefs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Depression and anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Traumatic Stress Disorder checklist (PCL-S)</measure>
    <time_frame>Baseline</time_frame>
    <description>Post Traumatic Stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of neck motion</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Range of motion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ergonomics questions and how work is perceived</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Work ergonomics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sickness presence by the Stanford presenteeism scale</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Sickness presence at work</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Enablement Instrument (PEI) questionnaire</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Patient enablement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of analgesic drugs prescribed through the drug registry</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Consumption of analgesic drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sick-leave registration, number of days and episodes</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Sick-leave</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive failures questionnaire (CFQ)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Cognitive function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensorimotor control of the neck muscles, mm Hg</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Sensorimotor control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck muscle endurance of ventral and dorsal neck muscles in seconds</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Neck muscle endurance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance measured in seconds, standing on one leg with eyes closed</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Balance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurology such as reflexes, sensibility, muscle weakness, Spurling´s test, neural tension test</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Neurology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasound registrations may be measured in a sub-group, deformation and deformation rate</measure>
    <time_frame>Change from baseline to 3 months follow-up</time_frame>
    <description>Neck muscle function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI may be measured in a sub-group.</measure>
    <time_frame>Change from baseline to 3 months follow-up</time_frame>
    <description>Neck muscle structure and maybe function</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Background data such as age and gender</measure>
    <time_frame>Baseline</time_frame>
    <description>Background data such as age, gender, living circumstances</description>
  </other_outcome>
  <other_outcome>
    <measure>Work Ability Index (WAI)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up</time_frame>
    <description>Self-reported work ability</description>
  </other_outcome>
  <other_outcome>
    <measure>Global rating of change scale</measure>
    <time_frame>Change from baseline to 3 months and 15 months follow-up, measured at follow-ups</time_frame>
    <description>overall change because of the treatment</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Whiplash Associated Disorders</condition>
  <arm_group>
    <arm_group_label>Exercises at a physiotherapy clinic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neck-specific exercise at a physiotherapy clinic, 24 times during 12 weeks (plus an additional first visit).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercises with Internet support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neck-specific exercise with Internet support combined with 3 visits at a physiotherapy clinic (plus an additional first visit), exercises mainly performed outside the health care system during 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neck-specific exercise</intervention_name>
    <description>Neck-specific exercise</description>
    <arm_group_label>Exercises at a physiotherapy clinic</arm_group_label>
    <arm_group_label>Exercises with Internet support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals with a whiplash injury in a traffic accident with a four-wheeled motor&#xD;
             vehicle at least 6 months ago but less than 5 years ago, with chronic neck problems&#xD;
             corresponding to Quebec Task Force (QTF) grades 2-3 verified in clinical examination&#xD;
&#xD;
          -  No participation in a neck-specific exercise program in a previous research study;&#xD;
&#xD;
          -  Average estimated pain in the preceding week more than 20 mm on the visual analogue&#xD;
             scale (VAS)&#xD;
&#xD;
          -  Neck disability for more than 20% of the Neck Disability Index&#xD;
&#xD;
          -  Working age, between 18 and 63 years&#xD;
&#xD;
          -  Daily access to computer/tablet/smart phone and Internet&#xD;
&#xD;
          -  Time to follow the treatment program&#xD;
&#xD;
          -  Neck symptoms within the first week after the injury (neck pain, neck stiffness, or&#xD;
             radiculopathy from the neck).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any of the following signs of brain damage at the time of injury: loss of&#xD;
             consciousness, amnesia before or after the injury, altered mental status (e.g.,&#xD;
             confusion, disorientation), focal neurological changes (changes in smell and taste)&#xD;
&#xD;
          -  Previous fractures or dislocation of the cervical column&#xD;
&#xD;
          -  Known or suspected serious physical pathology included myelopathy, spinal tumours,&#xD;
             spinal infection, or ongoing malignancy&#xD;
&#xD;
          -  Previous severe neck problems that resulted in sick leave for more than a month in the&#xD;
             year before the current whiplash injury&#xD;
&#xD;
          -  Surgery in the cervical column&#xD;
&#xD;
          -  Generalized or more dominant pain elsewhere in the body&#xD;
&#xD;
          -  Other illness/injury that may prevent full participation in the study and/or where&#xD;
             neck exercises are contraindicated&#xD;
&#xD;
          -  Inability to understand and write in Swedish&#xD;
&#xD;
          -  Diagnosed severe mental illness, e.g., psychosis, schizophrenia, personality disorders&#xD;
&#xD;
          -  Current alcohol or drug abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>63 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anneli Peolsson, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gunnel Peterson, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria Landén Ludvigsson, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anneli Peolsson</name>
      <address>
        <city>Linköping</city>
        <zip>58929</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Anneli Peolsson</investigator_full_name>
    <investigator_title>Professor, PhD, PT</investigator_title>
  </responsible_party>
  <keyword>Neck pain</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Exercise Therapy</keyword>
  <keyword>Internet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Whiplash Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03022812
org study id: 2016/135-31
nct id: NCT03022812
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Neck pain is fourth among the most common conditions worldwide associated with longer periods
      of living with disability. Annually, about 30 000 people in Sweden undergo a whiplash trauma
      (WAD), and half of those individuals will develop chronic problems with high costs for the
      individual and society. Evidence for chronic WAD treatment is scarce, although neck-specific
      training at a physiotherapy clinic (2 times a week for 3 months) has demonstrated good
      results. A more efficient, flexible rehabilitation with reduced waiting times and lower costs
      is needed, ideally replacing lengthy on-site treatment series by health care providers.
      Internet-based care has proven to be a viable alternative to personal care meetings for a
      variety of diseases and interventions, but studies are lacking on Internet-based
      interventions for individuals with chronic neck problems. The purpose of this study is to
      investigate if A) neck-specific training delivered through Internet-based care differs from
      B) a longer series of treatments at a physiotherapy clinic regarding, e.g., work ability,
      sick-leave and disability. This prospective, randomized study involves 140 participants.
      Measurement is done at baseline, 3 months (end of treatment), and 15 months (12 months after
      end of treatment in the study) and will include ratings of work ability, sick-leave, work
      presenteeism, disability, pain, health, satisfaction with care, quality of life, and
      cost-effectiveness. The study results may contribute to the development of a more effective
      rehabilitation, flexible and equal care, shorter waiting times, increased availability and
      lower costs for health care and society. The program can be implemented on a broader scale in
      neck pain patients.
The purpose of the study is to investigate if the effect of neck-specific exercises in people
      with chronic WAD (at risk for or at sick-leave) differs based on distribution via
      Internet-based care in combination with three visits (+ a first examination visit due to
      Swedish law) to the physiotherapist compared to a longer series (2 times/week for 3 months,
      i.e., 24 times + a first visit) of exercises at the physiotherapy clinic. Outcomes are for
      instance work ability, sick-leave, physical and psychological disability, pain, quality of
      life, satisfaction with treatment, and cost effectiveness. Further objectives are to a)
      describe the level of work ability, work presenteeism, and sick leave; b) determine which
      factors are related to a good work ability; c) identify factors predictive of a favourable
      outcome regarding work ability, disability, and pain; and d) describe how the participants
      perceived an Internet-based rehabilitation.

      Hypothesis: Internet-based support combined with a few (three) physiotherapist visits has an
      equivalent effect to a longer exercise period (24 times) at a physiotherapist clinic and
      yields lower economic costs for society.

      Design This is an experimental, longitudinal, prospective, multicentre randomized controlled
      trial (RCT) with two treatment arms. Treatment that has previously been shown to be effective
      (neck-specific exercises guided by a physiotherapist and performed at the physiotherapist
      clinic) for the current population constitutes the control treatment for the new
      Internet-based neck-specific exercise treatment. A total of 140 people are expected to be
      included, 70 in each group (sample size estimated by statisticians). Independent
      physiotherapists in primary care clinical practice will distribute the treatment. The project
      manager will not be a test leader.

      Recruitment and randomization Interested patients will contact the research team (experienced
      physiotherapists), and after a small survey filled in by the potential participant, a project
      team member will perform a telephone interview, ask about the medical history, and perform a
      physical examination to ensure that criteria for study participation are met. If the study
      criteria are met and after written and oral informed consent of the patient, the patient will
      fill out a questionnaire (baseline data) and undergo physical measurements of neck-related
      function. Baseline measurements must be completed for inclusion.

      The patient will be randomized through a computerized randomization list (block randomization
      conducted by a statistician, stratification by gender) to one of two groups of 3 months of
      treatment with neck-specific exercises: A) exercises at a physiotherapy clinic 2 times/week
      for 3 months; or B) Internet-based support exercises in combination with four visits to the
      physiotherapist. The test leader is blinded for group allocation. The randomization is
      performed by an independent researcher not otherwise involved in any of the test or
      treatments. The researcher sends an opaque envelope containing the name and contact details
      of the patient and information about the randomization group to the treating physiotherapist,
      who calls the patient to a new clinical examination (by law) before treatment can start. Due
      to the nature of the study neither participants nor treating therapists can be blinded,
      however all tests are done by blinded test leaders. Data collection in the form of
      questionnaires and tests of physical neck-related function occurs at baseline (before
      randomization) and after 3 months (when the treatment ends) and 15 months (12 months after
      completion of the intervention in the project). The treating physiotherapists will receive
      oral and written information and a day of practical training. The treating physiotherapist is
      also able to consult with the project managers at any time if necessary. An exercise diary is
      maintained by patients in both groups, and the number of care contacts is recorded by the
      physiotherapist. Seventy people per group, i.e., a total of 140 participants with chronic WAD
      grades 2 and 3, will be recruited.

      Intervention Group A, neck-specific exercises at a physiotherapy clinic: Participants get an
      explanation and justification for the exercise. They undergo a 12-week training program with
      a physiotherapist 2 times/week. Exercises are chosen from a clear and written frame of
      exercises, although the dosages are individually adapted. The training includes exercises
      activating the deep neck muscles, continuing with the endurance training of neck and shoulder
      muscles. The exercises are individually adjusted according to the individual's physical
      conditions and progressively increased in severity and dose. Exercise-related pain
      provocation is not accepted. The individual may also carry out home exercises. At the end of
      the treatment period, the patient is encouraged to continue practicing on their own.

      Group B, neck-specific exercises with Internet support: Participants receive the same
      information and training programs as group A but have in total only four visits (a first
      examination visit and additional three visits) to the physiotherapist. When the exercises are
      introduced, they are repeated, and control is done so that the patient has understood how to
      conduct the exercises. The exercises take place, with the help of Internet support outside
      the health care system, probably mostly at home. Photos and videos of the exercises,
      information, and answers to frequently asked questions are available on the Internet
      (web-based system designed by the project leaders at the University). Patients can contact a
      physiotherapist if necessary, and can normally expect an answer within 3 days.

      Any important harms or unintended effects in each group will be collected by the test
      leaders.

      Sample size Sample size calculations in the study regarding group differences are calculated
      by a statistician (non-inferiority trial, an assumption that treatment B is not worse than
      A), and power is calculated by the software "G-POWER" and is based on the primary outcome
      measurements WAI and NDI. Regarding WAI, it is considered important that the participants
      improve from poor to moderate work ability, i.e., an average of 6 increments in a scale 7-47
      (can also be classified into four groups: poor, moderate, good, and excellent). With a
      significance level of 5% and a power of 80%, seven people in each classification group are
      required. To get seven people in the "poor group" requires 60 people in total. To detect a
      clinically relevant improvement in NDI of 7%, 47 participants per group are needed on the
      basis of 80% power at a significance level of 5%. This value is based on the standard
      deviation (SD 13.4) in the NDI in a previous study on neck-specific exercises of individuals
      with chronic WAD grades 2 and 3. To ensure that enough people are in each group after
      drop-outs, for prediction analyses, and some possibility for subgroup analyses (e.g., WAD
      grades 2 and 3 or between men and women), the recommendation from the statistician was to
      include 70 people/group.

      Ethical considerations The study was approved by the regional ethical review board (Linköping
      Dnr 2016 / 135-31). A previous clinical study relating to three different exercise
      interventions on long-term problems after whiplash injury demonstrated good efficacy of
      neck-specific exercise performed in primary health care. Current treatment is according to
      the best scientific evidence, and exercises used in the present study have been used in daily
      clinical practice for decades in the rehabilitation of various forms of neck pain.
      Participants are included after a thorough clinical examination and signed informed (oral and
      written information) consent. The exercises are adjusted individually. A risk of muscle
      soreness is present, but otherwise no negative side effects are to be expected.

      Login is required to fill in Internet-based surveys and to gain access to the Internet-based
      exercise program. People with long-term problems often have low access to assessments and
      treatments as more acute conditions often are prioritized in the health care system. Both
      groups in the present study get active care that is expected to increase work ability. The
      benefit is deemed to be great, and there are no commercial interests.

      The results will be presented at group level, and no connection to the individual person can
      be made. All data are anonymous and subject to the official health secrets act.

      Statistical analysis Analyses will be done with parametric or non-parametric statistics,
      depending on the type of data and if the analysis is between groups or over time. Analyses
      will primarily be made on an intention-to-treat basis and as secondary as per protocol
      analysis. When suitable a linear mixed model analysis will be used. For prediction analysis,
      multivariate analysis will be performed. For calculation of cost-effectiveness,
      quality-adjusted life-years and incremental cost-effective ratios will be calculated.

      Sub-group analyses regarding gender, WAD grade, neurology, headache, dizziness and compliance
      may be done.

      Ultrasound registrations, electromyopgraphy, Magnetic Resonance Imaging and kinesthesia may
      be done on a sub-group of participants to investigate neck muscle structure and function.
      Interviews may be performed on a sub group of individuals to investigate the experience of
      function and study participation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Neck Disability Index (NDI)
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Self-reported neck-specific function
measure: Whiplash Disability Questionnaire
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Disability associated with whiplash
measure: Patient-specific functional scale (PSFS)
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Individual ratings of function
measure: Pain intensity in neck, head, and arm and dizziness by a VAS (0-100 mm)
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Pain intensity
measure: Distribution of pain by a pain drawing assessed with images
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Distribution of pain
measure: Frequency of pain
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Frequency of pain
measure: Use of pain medications
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Use of pain medications
measure: Dizziness/balance by the Dizziness Handicap Inventory (DHI)
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Dizziness questionnaire
measure: Headache Questions by VAS and the Headache Impact Test (HIT-6)
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Impact of headache
measure: Pain Catastrophizing Scale
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Self-reported pain catastrophizing
measure: EuroQuol five dimensions
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Self-reported health
measure: Effort Reward Imbalance questionnaire
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Work related balance between effort and reward
measure: Symptoms Satisfaction scale
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Satisfaction with present symptoms
measure: Physical activity score, a combination score of the 2 questions (everyday physical activity and exercise/sport/open-air activity) to a combined 4-point score
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Physical activity
measure: Health care consumption, number of visits
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Health care consumption
measure: Self-Efficacy Scale (SES)
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Self-reported self-efficacy
measure: Fear Avoidance Beliefs Questionnaire (FABQ)
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Fear Avoidance Beliefs
measure: Hospital Anxiety and Depression Scale
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Depression and anxiety
measure: Post Traumatic Stress Disorder checklist (PCL-S)
time frame: Baseline
description: Post Traumatic Stress
measure: Range of neck motion
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Range of motion
measure: Ergonomics questions and how work is perceived
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Work ergonomics
measure: Sickness presence by the Stanford presenteeism scale
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Sickness presence at work
measure: Patient Enablement Instrument (PEI) questionnaire
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Patient enablement
measure: Consumption of analgesic drugs prescribed through the drug registry
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Consumption of analgesic drugs
measure: Sick-leave registration, number of days and episodes
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Sick-leave
measure: Cognitive failures questionnaire (CFQ)
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Cognitive function
measure: Sensorimotor control of the neck muscles, mm Hg
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Sensorimotor control
measure: Neck muscle endurance of ventral and dorsal neck muscles in seconds
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Neck muscle endurance
measure: Balance measured in seconds, standing on one leg with eyes closed
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Balance
measure: Neurology such as reflexes, sensibility, muscle weakness, Spurling´s test, neural tension test
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Neurology
measure: Ultrasound registrations may be measured in a sub-group, deformation and deformation rate
time frame: Change from baseline to 3 months follow-up
description: Neck muscle function
measure: MRI may be measured in a sub-group.
time frame: Change from baseline to 3 months follow-up
description: Neck muscle structure and maybe function
measure: Background data such as age and gender
time frame: Baseline
description: Background data such as age, gender, living circumstances
measure: Work Ability Index (WAI)
time frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
description: Self-reported work ability
measure: Global rating of change scale
time frame: Change from baseline to 3 months and 15 months follow-up, measured at follow-ups
description: overall change because of the treatment
arm group label: Exercises at a physiotherapy clinic
arm group type: Active Comparator
description: Neck-specific exercise at a physiotherapy clinic, 24 times during 12 weeks (plus an additional first visit).
arm group label: Exercises with Internet support
arm group type: Experimental
description: Neck-specific exercise with Internet support combined with 3 visits at a physiotherapy clinic (plus an additional first visit), exercises mainly performed outside the health care system during 12 weeks.
intervention type: Other
intervention name: Neck-specific exercise
description: Neck-specific exercise
arm group label: Exercises at a physiotherapy clinic
arm group label: Exercises with Internet support
criteria: 
gender: All
minimum age: 18 Years
maximum age: 63 Years
healthy volunteers: No
last name: Anneli Peolsson, Professor
role: Principal Investigator
affiliation: Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden
last name: Gunnel Peterson, PhD
role: Study Chair
affiliation: Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden
last name: Maria Landén Ludvigsson, PhD
role: Study Chair
affiliation: Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Anneli Peolsson
investigator title: Professor, PhD, PT
mesh term: Whiplash Injuries
sharing ipd: No