<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/NCT03036007</url>
  </required_header>
  <id_info>
    <org_study_id>2016 / 283-31</org_study_id>
    <nct_id>NCT03036007</nct_id>
  </id_info>
  <brief_title>Physiotherapy After Anterior Cervical Spine Surgery</brief_title>
  <official_title>Physiotherapy After Anterior Cervical Spine Surgery for Cervical Disc Disease. A Prospective Randomised Study to Compare Internet-based Neck-specific Exercise With Prescribed Physical Activity</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>
      Background: Patients suffering residual disability after anterior decompression and fusion&#xD;
      (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or&#xD;
      neck-specific exercises (NSE). Currently, we lack data for the success of either approach.&#xD;
      There is also a knowledge-gap concerning the use of internet-based care for chronic neck&#xD;
      pain, inclusive of cervical disc disease. The scarcity of these data, and the high proportion&#xD;
      of patients with various degrees of incapacity following ACDF, warrants increased efforts to&#xD;
      investigate and improve cost-effective rehabilitation.&#xD;
&#xD;
      Objective: To investigate the effectiveness of a structured, internet-based NSE program,&#xD;
      versus PPA following ACDF surgery.&#xD;
&#xD;
      Methods: This is a prospective, randomised, experimental, longitudinal multicentre study,&#xD;
      that includes 140 patients with residual disability (≥30% on the Neck Disability Index; NDI)&#xD;
      following ACDF for radiculopathy due to cervical disc disease. Patient recruitment occurs&#xD;
      following attendance at routine clinical appointments, scheduled for 3-months post-surgery.&#xD;
      Patients are then randomised to one of two groups (70 patients/group), scheduled for a&#xD;
      3-month treatment of either internet-based NSE or PPA. Questionnaires on background data,&#xD;
      pain and discomfort, physical and mental capacity, satisfaction with care, and health and&#xD;
      workplace factors are completed, with physical measurements of neck-related function&#xD;
      performed by independent test leaders blinded to randomisation. Measurements are performed at&#xD;
      inclusion, after the 3-month treatments (end of treatment), and at a 2-year follow-up.&#xD;
      Radiography will be completed at the 2-year follow-up. Preoperative data will be collected&#xD;
      from the Swedish Spine Registry (Swespine). Data on healthcare consumption, drug use, and&#xD;
      sick leave will be requested from the relevant national registers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to investigate whether internet-based, structured NSE, differs&#xD;
      from PPA after surgery for cervical disc disease, in relation to function, pain, work&#xD;
      capacity, health-related quality of life, satisfaction with care, and cost effectiveness.&#xD;
&#xD;
      The hypothesis is that internet-based NSE will be superior in terms of outcome measures to&#xD;
      PPA. This assumption, based on an earlier study of patients with chronic WAD, remains&#xD;
      untested for individuals with residual disability following ACDF. The project is expected to&#xD;
      lead to improved care, well-being, and patient satisfaction, and, as a result, a reduced&#xD;
      societal burden.&#xD;
&#xD;
      Design This is a prospective, randomised, experimental longitudinal multicentre study, with a&#xD;
      two-year follow-up. Questionnaires are distributed and physical measurements taken at&#xD;
      baseline, at the end of treatment (3 months after enrolment), and after 2 years. Preoperative&#xD;
      data is collected from Swespine. Patients are recruited from the surgical unit following&#xD;
      regular follow-up visits to the physiotherapist/surgeon at approximately 3 months&#xD;
      postoperatively.&#xD;
&#xD;
      Should the study criteria be met, and after the receipt of written and oral informed consent,&#xD;
      the patient completes a questionnaire and undergoes physical measurements of neck-related&#xD;
      function. The patient is then randomised (computerised block randomisation list compiled by&#xD;
      statisticians) to one of two groups for 3 months of treatment with a) internet-based NSE with&#xD;
      3 visits to the physiotherapist or b) PPA with 3 visits to the physiotherapist. In addition,&#xD;
      and prior to treatment, patients in both groups are examined by a physiotherapist, in&#xD;
      accordance with Swedish law.&#xD;
&#xD;
      The test leader is a physiotherapist at the surgical unit who is not involved in study&#xD;
      treatment and is blinded to the randomisation groups. Qualified clinicians will perform&#xD;
      X-rays and (potentially) ultrasound registration. Following randomization the results will be&#xD;
      put into an opaque envelope that contains the name of the patient and their randomisation&#xD;
      group, which is sent to the physiotherapy outpatient care clinic. Questionnaires and tests of&#xD;
      physical neck-related function are conducted at baseline (before randomisation), after 3&#xD;
      months (when the treatment ends), and after 2 years. Participant physiotherapists will be&#xD;
      provided oral, written, and practical training, and are able to consult project managers at&#xD;
      any time. Exercise diaries and the number of care contacts will be recorded for both groups.&#xD;
&#xD;
      Study criteria&#xD;
&#xD;
      Inclusion criteria for each surgical department:&#xD;
&#xD;
      • Record data in Swespine&#xD;
&#xD;
      Inclusion criteria for surgery:&#xD;
&#xD;
        -  Cervical disc disease, confirmed by MRI data compatible with clinical findings&#xD;
           (neurological examination performed by neck surgeon i.e. neurosurgeon/orthopaedic&#xD;
           surgeon) that show nerve root compression in the cervical spine.&#xD;
&#xD;
        -  Radiculopathy with pain in one or both arms, with or without sensory and/or motor&#xD;
           deficit&#xD;
&#xD;
        -  At least 3 months of persistent arm pain&#xD;
&#xD;
      Inclusion criteria for the study:&#xD;
&#xD;
        -  ACDF due to cervical disc disease (disc herniation with or without osteophytes, or&#xD;
           stenosis caused by osteophytes) in one or two segmental levels&#xD;
&#xD;
        -  Age 18-75 years&#xD;
&#xD;
        -  Residual disability (approximately) 3 months after surgery (at the re-visit to the&#xD;
           surgeon/ physiotherapist at the neurosurgery/ neuroorthopedic clinic) in terms of the&#xD;
           Neck Disability Index (NDI ≥30%).&#xD;
&#xD;
        -  Access to a computer/tablet/smartphone and the Internet&#xD;
&#xD;
        -  Motivated to exercise&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Myelopathy&#xD;
&#xD;
        -  Previous fracture or dislocation of the cervical spine&#xD;
&#xD;
        -  Malignancy or benign spinal tumour (e.g. neuromas)&#xD;
&#xD;
        -  Spinal infection, ongoing post-operative infection, or previous spondylodiscitis&#xD;
&#xD;
        -  Previous cervical spine surgery&#xD;
&#xD;
        -  Factors that are contraindicated for study participation or which hinder treatment or&#xD;
           follow-up because of systemic disease, physical or mental illness, injury,&#xD;
           inconvenience, or postoperative complications.&#xD;
&#xD;
        -  Known alcohol/drug abuse&#xD;
&#xD;
        -  Lack of ability to write/comprehend/or express oneself in the Swedish language&#xD;
&#xD;
      Intervention Internet-based neck-specific exercise (NSE) Participants will be provided with&#xD;
      an explanation and justification for their exercise. Training includes exercises to activate&#xD;
      the deep neck muscles (initially daily), continuing with endurance training of the neck and&#xD;
      shoulder muscles (3 times/week). Exercise will be tailored to the individual's physical&#xD;
      condition, and then scaled up progressively in terms of severity and dose. Participants will&#xD;
      undertake three visits to the physiotherapist, where the exercises will be introduced and&#xD;
      repeated, in order to establish and control patient comprehension. The exercise is completed&#xD;
      with the help of internet support outside of the healthcare system, which can be accessed&#xD;
      anywhere, but most probably at home. Photos and videos of the exercises, information, and&#xD;
      answers to frequently asked questions are available on the internet-support platform.&#xD;
      Patients can contact a physiotherapist by e-mail if necessary. Three visits to the&#xD;
      physiotherapist are provided in addition to a mandatory first visit (for new clinical&#xD;
      investigations as required by Swedish law). At the end of the treatment period, the patients&#xD;
      are encouraged to continue practicing the exercises on their own.&#xD;
&#xD;
      Prescribed physical activity (PPA) The training consists of general, physical, land-based&#xD;
      activity (3 times/week). The aim is to find a physical activity outside of the care unit that&#xD;
      suits the individual, based on their specific needs and problems. The goal is that the&#xD;
      individual should increase their overall level of physical activity, and that that activity&#xD;
      is performed as part of a self-care/wellness routine. This may involve activities that can be&#xD;
      performed at home, such as walking according to a set schedule, home exercises given by a&#xD;
      physiotherapist (not neck-specific training), and aerobic classes etc. To increase&#xD;
      compliance, a simple motivational interview is performed before the PPA schedule is provided,&#xD;
      which can occur during the same session or at a separate visit, should the physiotherapist&#xD;
      and patient prefer. Patients are advised to contact the physiotherapist should their&#xD;
      prescribed activity fail to work so that another activity can be identified. Three visits to&#xD;
      the physiotherapist are provided in addition to a mandatory first visit (for new clinical&#xD;
      investigations as required by Swedish law), with the patient encouraged to continue&#xD;
      practicing on their own at the end of the treatment period.&#xD;
&#xD;
      Sample size calculation and statistics Seventy participants per group (i.e. a total of 140&#xD;
      patients) are required. Sample size calculations (conducted by statisticians) are based on&#xD;
      the primary outcome measure of Neck Disability Index (NDI). In order to detect a clinically&#xD;
      relevant improvement of 10 NDI points, 70 participants per group are needed (assuming 80%&#xD;
      power, and a level of significance of 5%). This calculation is based on group differences&#xD;
      recorded in previous studies. These include a study in which individuals with chronic&#xD;
      whiplash-associated injuries were offered training, as well as a study investigating the&#xD;
      benefits of surgery over and above physical therapy for cervical disc disease.&#xD;
&#xD;
      As we lack any studies on rehabilitation for patients with disability after ACDF, this&#xD;
      calculation remains hypothetical and our sample size may need to be adjusted after the first&#xD;
      30 people (15/group) have completed the 3-month follow-up. This number can also be adjusted&#xD;
      in the event of participants dropping-out, such that at least 70 individuals per group&#xD;
      complete the intervention. Data will be analysed using an intention-to-treat approach.&#xD;
      Alternative analyses (sub-group analyses) will be carried out where the degree of&#xD;
      implementation of treatment (compliance) is taken into account, as well as sex, dizziness,&#xD;
      headaches, neurological findings, and the number of segmental levels operated on. Analyses&#xD;
      will be performed using parametric or non-parametric statistics, depending on the type of&#xD;
      data, in consultation with statisticians as appropriate.&#xD;
&#xD;
      Ultrasound registrations, electromyography, Magnetic Resonance Imaging and kinesthesia may be&#xD;
      done on a sub-group of participants to investigate neck muscle structure and function.&#xD;
      Interviews may be done on a sub-group of individuals regarding their function, experiences&#xD;
      and opinions.&#xD;
&#xD;
      Ethical considerations This study was approved by the Regional Ethical Review Board in&#xD;
      Linköping Ref: 2016 / 283-31. The scientists are independent with no commercial ties.&#xD;
      Patients are recruited after providing informed consent. Patient data are presented at the&#xD;
      group level such that no connection to any individual can be made. All data are anonymised&#xD;
      when reported, and subject to the Official Secrets Health Acts. The test leaders are&#xD;
      independent and blinded for randomisation. Exercises, both general and neck-specific, have&#xD;
      been used extensively in clinical practice and we anticipate no harm from their&#xD;
      implementation other than a risk of muscle soreness. Any important harms or unintended&#xD;
      effects in each group will be collected by the test leaders. All questionnaires and test&#xD;
      materials are encoded by the research group, with code lists stored in locked, fireproof file&#xD;
      cabinets, housed at the university in a room with controlled (card-based) access. Only&#xD;
      individuals in receipt of a unique website address posted by the researchers can access the&#xD;
      program; patients can neither communicate with each other nor with caregivers via the&#xD;
      program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 22, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>
    <masking_description>Single Blind (Outcomes Assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Neck Disability Index (NDI)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up. Preoperative data from the Swespine register</time_frame>
    <description>Self-reported neck-specific function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensities of the neck, arm, and head, measured using the Visual Analogue Scale (VAS 0-100 mm).</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up. Pre-operative data from the Swespine register</time_frame>
    <description>Pain intensity VAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensities for the neck and arm will be assessed and registered using the Numeric Rating Scale (NRS) 0-10 scale in accordance with the Swespine registry</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Pain intensity NRS</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 24 months follow-up</time_frame>
    <description>painful areas are shaded on a human body image</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of pain medications</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Use of pain medications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Odom</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>global outcomes of the intervention</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 24 months follow-up</time_frame>
    <description>Self-reported dizziness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache questions by VAS and the Headache Handicap Inventory (HIT-6)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Impact of headache</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disaster thoughts measured by the Pain Catastrophising Scale (PCS).</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Disaster thoughts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confidence in ability measured by the Self-Efficacy Scale (SES).</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Confidence in ability</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 24 months follow-up</time_frame>
    <description>Estimation of neck-specific function related to participants' chosen activities (daily function, work, spare time</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 24 months follow-up</time_frame>
    <description>Operating fear</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HAD).</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Self-reported anxiety and depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life measured by the EuroQuol five dimensions (EQ-5D)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Health related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Ability Index (WAI), short form</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Self-rated work ability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Requirements - effort support in the workplace: Effort Reward Imbalance (ERI)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>effort and support in the workplace</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 24 months follow-up</time_frame>
    <description>Work ergonomics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sickness presence measured by the Stanford preseenteism scale</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Sickness presence at work</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swedish Standard Classification of Occupations (SSY) code</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Classification of Occupations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Enablement Instrument (PEI) questionnaire</measure>
    <time_frame>Follow-up at 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Patient Enablement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with symptoms measured by the Cherkin symptom satisfaction scale</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Satisfaction with symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of physical activity score, a combination of 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 24 months 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 24 months follow-up</time_frame>
    <description>Health-care consumption</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 24 months follow-up</time_frame>
    <description>Consumption of analgesic drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of pain</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Frequency of pain</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 24 months follow-up</time_frame>
    <description>Sick-leave registration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck movement measured using the cervical range of motion device (CROM) in degrees</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Active range of motion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endurance in the dorsal and ventral neck muscles, measured in seconds</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Neck muscle endurance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensorimotor control of ventral neck muscles, in the supine position, with stabilizer (mm HG)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Sensorimotor control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurology, clinical judgement yes/no</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Neurology, such as reflexes, sensibility, muscle weakness and neural tension test. The results of the neurological examination gives an overall clinical judgement if segmental neurological findings is present and which cervical segmental level/ - is involved,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand strength measured with a hand dynamometer (Jamar)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Hand strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standing on one leg with eyes closed (Solec test)</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Static balance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conventional radiography, with side views taken during neutral positioning and dynamic flexion/extension</measure>
    <time_frame>Occurs routinely in the clinic for visits 3 months after surgery. Additional X-rays will be taken at the 2-year follow up to</time_frame>
    <description>Examination of implants, the degree of mobility of operated segments, subsidence and fusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Register data for care use. To measure/monitor care use</measure>
    <time_frame>Change from baseline to 3 months (the end of treatment) and 24 months follow-up</time_frame>
    <description>Care use</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>
  <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>Global rating of change scale</measure>
    <time_frame>Change from baseline to 3 and 24 months follow-ups, measured at follow-ups</time_frame>
    <description>Overall change because of the treatment</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 and earlier care</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Cervical Disc Disease</condition>
  <condition>Radiculopathy, Cervical</condition>
  <arm_group>
    <arm_group_label>Prescribed Physical Activity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>General physical exercises 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>
  <arm_group>
    <arm_group_label>Exercises with Internet support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neck-specific exercises 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>Prescribed Physical Activity</intervention_name>
    <description>General physical activity prescribed by a physiotherapist</description>
    <arm_group_label>Prescribed Physical Activity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercises with Internet support</intervention_name>
    <description>Neck-specific exercise with Internet support</description>
    <arm_group_label>Exercises with Internet support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria for each surgical department:&#xD;
&#xD;
        • Record data in Swespine&#xD;
&#xD;
        Inclusion criteria for surgery:&#xD;
&#xD;
          -  Cervical disc disease, confirmed by MRI data compatible with clinical findings&#xD;
             (neurological examination performed by neck surgeon i.e. neurosurgeon/orthopaedic&#xD;
             surgeon) that show nerve root compression in the cervical spine.&#xD;
&#xD;
          -  Radiculopathy with pain in one or both arms, with or without sensory and/or motor&#xD;
             deficit&#xD;
&#xD;
          -  At least 3 months of persistent arm pain&#xD;
&#xD;
        Inclusion criteria for the study:&#xD;
&#xD;
          -  ACDF due to cervical disc disease (disc herniation with or without osteophytes, or&#xD;
             stenosis caused by osteophytes) in one or two segmental levels&#xD;
&#xD;
          -  Aged 18-75 years&#xD;
&#xD;
          -  Residual disability (approximately) 3 months after surgery (at the re-visit to the&#xD;
             surgeon/ physiotherapist at the neurosurgery/ neuroorthopedic clinic) in terms of the&#xD;
             Neck Disability Index (NDI ≥30%).&#xD;
&#xD;
          -  Access to a computer/tablet/smartphone and the Internet&#xD;
&#xD;
          -  Motivated to exercise&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Myelopathy&#xD;
&#xD;
          -  Previous fracture or dislocation of the cervical spine&#xD;
&#xD;
          -  Malignancy or benign spinal tumour (e.g. neuromas)&#xD;
&#xD;
          -  Spinal infection, ongoing post-operative infection, or previous spondylodiscitis&#xD;
&#xD;
          -  Previous cervical spine surgery&#xD;
&#xD;
          -  Factors that are contraindicated for study participation or which hinder treatment or&#xD;
             follow-up because of systemic disease, physical or mental illness, injury,&#xD;
             inconvenience, or postoperative complications.&#xD;
&#xD;
          -  Known alcohol/drug abuse&#xD;
&#xD;
          -  Lack of ability to write/comprehend/or express oneself in the Swedish language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 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_contact>
    <last_name>Anneli Peolsson, Professor</last_name>
    <phone>+46-13284601</phone>
    <email>Anneli.Peolsson@liu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Håkan Löfgren, PhD, MD</last_name>
    <phone>+46-102410000</phone>
    <email>Hakan.Lofgren@rjl.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Anneli Peolsson</name>
      <address>
        <city>Linköping</city>
        <state>Östergötland</state>
        <zip>SE-58183</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anneli Peolsson, Assoc. Prof.</last_name>
      <phone>+46-101031798</phone>
      <email>Anneli.Peolsson@liu.se</email>
    </contact>
    <contact_backup>
      <last_name>Gunnel Peterson, MSc</last_name>
      <phone>+46-722100901</phone>
      <email>Gunnel.Peterson@liu.se</email>
    </contact_backup>
    <investigator>
      <last_name>Anneli Peolsson, Assoc.Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gunnel Peterson, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</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>Spine, Disc, Neck pain, Rehabilitation, Exercise Therapy, Internet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Radiculopathy</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/NCT03036007
org study id: 2016 / 283-31
nct id: NCT03036007
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Patients suffering residual disability after anterior decompression and fusion
      (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or
      neck-specific exercises (NSE). Currently, we lack data for the success of either approach.
      There is also a knowledge-gap concerning the use of internet-based care for chronic neck
      pain, inclusive of cervical disc disease. The scarcity of these data, and the high proportion
      of patients with various degrees of incapacity following ACDF, warrants increased efforts to
      investigate and improve cost-effective rehabilitation.

      Objective: To investigate the effectiveness of a structured, internet-based NSE program,
      versus PPA following ACDF surgery.

      Methods: This is a prospective, randomised, experimental, longitudinal multicentre study,
      that includes 140 patients with residual disability (≥30% on the Neck Disability Index; NDI)
      following ACDF for radiculopathy due to cervical disc disease. Patient recruitment occurs
      following attendance at routine clinical appointments, scheduled for 3-months post-surgery.
      Patients are then randomised to one of two groups (70 patients/group), scheduled for a
      3-month treatment of either internet-based NSE or PPA. Questionnaires on background data,
      pain and discomfort, physical and mental capacity, satisfaction with care, and health and
      workplace factors are completed, with physical measurements of neck-related function
      performed by independent test leaders blinded to randomisation. Measurements are performed at
      inclusion, after the 3-month treatments (end of treatment), and at a 2-year follow-up.
      Radiography will be completed at the 2-year follow-up. Preoperative data will be collected
      from the Swedish Spine Registry (Swespine). Data on healthcare consumption, drug use, and
      sick leave will be requested from the relevant national registers.
The purpose of the study is to investigate whether internet-based, structured NSE, differs
      from PPA after surgery for cervical disc disease, in relation to function, pain, work
      capacity, health-related quality of life, satisfaction with care, and cost effectiveness.

      The hypothesis is that internet-based NSE will be superior in terms of outcome measures to
      PPA. This assumption, based on an earlier study of patients with chronic WAD, remains
      untested for individuals with residual disability following ACDF. The project is expected to
      lead to improved care, well-being, and patient satisfaction, and, as a result, a reduced
      societal burden.

      Design This is a prospective, randomised, experimental longitudinal multicentre study, with a
      two-year follow-up. Questionnaires are distributed and physical measurements taken at
      baseline, at the end of treatment (3 months after enrolment), and after 2 years. Preoperative
      data is collected from Swespine. Patients are recruited from the surgical unit following
      regular follow-up visits to the physiotherapist/surgeon at approximately 3 months
      postoperatively.

      Should the study criteria be met, and after the receipt of written and oral informed consent,
      the patient completes a questionnaire and undergoes physical measurements of neck-related
      function. The patient is then randomised (computerised block randomisation list compiled by
      statisticians) to one of two groups for 3 months of treatment with a) internet-based NSE with
      3 visits to the physiotherapist or b) PPA with 3 visits to the physiotherapist. In addition,
      and prior to treatment, patients in both groups are examined by a physiotherapist, in
      accordance with Swedish law.

      The test leader is a physiotherapist at the surgical unit who is not involved in study
      treatment and is blinded to the randomisation groups. Qualified clinicians will perform
      X-rays and (potentially) ultrasound registration. Following randomization the results will be
      put into an opaque envelope that contains the name of the patient and their randomisation
      group, which is sent to the physiotherapy outpatient care clinic. Questionnaires and tests of
      physical neck-related function are conducted at baseline (before randomisation), after 3
      months (when the treatment ends), and after 2 years. Participant physiotherapists will be
      provided oral, written, and practical training, and are able to consult project managers at
      any time. Exercise diaries and the number of care contacts will be recorded for both groups.

      Study criteria

      Inclusion criteria for each surgical department:

      • Record data in Swespine

      Inclusion criteria for surgery:

        -  Cervical disc disease, confirmed by MRI data compatible with clinical findings
           (neurological examination performed by neck surgeon i.e. neurosurgeon/orthopaedic
           surgeon) that show nerve root compression in the cervical spine.

        -  Radiculopathy with pain in one or both arms, with or without sensory and/or motor
           deficit

        -  At least 3 months of persistent arm pain

      Inclusion criteria for the study:

        -  ACDF due to cervical disc disease (disc herniation with or without osteophytes, or
           stenosis caused by osteophytes) in one or two segmental levels

        -  Age 18-75 years

        -  Residual disability (approximately) 3 months after surgery (at the re-visit to the
           surgeon/ physiotherapist at the neurosurgery/ neuroorthopedic clinic) in terms of the
           Neck Disability Index (NDI ≥30%).

        -  Access to a computer/tablet/smartphone and the Internet

        -  Motivated to exercise

      Exclusion criteria:

        -  Myelopathy

        -  Previous fracture or dislocation of the cervical spine

        -  Malignancy or benign spinal tumour (e.g. neuromas)

        -  Spinal infection, ongoing post-operative infection, or previous spondylodiscitis

        -  Previous cervical spine surgery

        -  Factors that are contraindicated for study participation or which hinder treatment or
           follow-up because of systemic disease, physical or mental illness, injury,
           inconvenience, or postoperative complications.

        -  Known alcohol/drug abuse

        -  Lack of ability to write/comprehend/or express oneself in the Swedish language

      Intervention Internet-based neck-specific exercise (NSE) Participants will be provided with
      an explanation and justification for their exercise. Training includes exercises to activate
      the deep neck muscles (initially daily), continuing with endurance training of the neck and
      shoulder muscles (3 times/week). Exercise will be tailored to the individual's physical
      condition, and then scaled up progressively in terms of severity and dose. Participants will
      undertake three visits to the physiotherapist, where the exercises will be introduced and
      repeated, in order to establish and control patient comprehension. The exercise is completed
      with the help of internet support outside of the healthcare system, which can be accessed
      anywhere, but most probably at home. Photos and videos of the exercises, information, and
      answers to frequently asked questions are available on the internet-support platform.
      Patients can contact a physiotherapist by e-mail if necessary. Three visits to the
      physiotherapist are provided in addition to a mandatory first visit (for new clinical
      investigations as required by Swedish law). At the end of the treatment period, the patients
      are encouraged to continue practicing the exercises on their own.

      Prescribed physical activity (PPA) The training consists of general, physical, land-based
      activity (3 times/week). The aim is to find a physical activity outside of the care unit that
      suits the individual, based on their specific needs and problems. The goal is that the
      individual should increase their overall level of physical activity, and that that activity
      is performed as part of a self-care/wellness routine. This may involve activities that can be
      performed at home, such as walking according to a set schedule, home exercises given by a
      physiotherapist (not neck-specific training), and aerobic classes etc. To increase
      compliance, a simple motivational interview is performed before the PPA schedule is provided,
      which can occur during the same session or at a separate visit, should the physiotherapist
      and patient prefer. Patients are advised to contact the physiotherapist should their
      prescribed activity fail to work so that another activity can be identified. Three visits to
      the physiotherapist are provided in addition to a mandatory first visit (for new clinical
      investigations as required by Swedish law), with the patient encouraged to continue
      practicing on their own at the end of the treatment period.

      Sample size calculation and statistics Seventy participants per group (i.e. a total of 140
      patients) are required. Sample size calculations (conducted by statisticians) are based on
      the primary outcome measure of Neck Disability Index (NDI). In order to detect a clinically
      relevant improvement of 10 NDI points, 70 participants per group are needed (assuming 80%
      power, and a level of significance of 5%). This calculation is based on group differences
      recorded in previous studies. These include a study in which individuals with chronic
      whiplash-associated injuries were offered training, as well as a study investigating the
      benefits of surgery over and above physical therapy for cervical disc disease.

      As we lack any studies on rehabilitation for patients with disability after ACDF, this
      calculation remains hypothetical and our sample size may need to be adjusted after the first
      30 people (15/group) have completed the 3-month follow-up. This number can also be adjusted
      in the event of participants dropping-out, such that at least 70 individuals per group
      complete the intervention. Data will be analysed using an intention-to-treat approach.
      Alternative analyses (sub-group analyses) will be carried out where the degree of
      implementation of treatment (compliance) is taken into account, as well as sex, dizziness,
      headaches, neurological findings, and the number of segmental levels operated on. Analyses
      will be performed using parametric or non-parametric statistics, depending on the type of
      data, in consultation with statisticians as appropriate.

      Ultrasound registrations, electromyography, Magnetic Resonance Imaging and kinesthesia may be
      done on a sub-group of participants to investigate neck muscle structure and function.
      Interviews may be done on a sub-group of individuals regarding their function, experiences
      and opinions.

      Ethical considerations This study was approved by the Regional Ethical Review Board in
      Linköping Ref: 2016 / 283-31. The scientists are independent with no commercial ties.
      Patients are recruited after providing informed consent. Patient data are presented at the
      group level such that no connection to any individual can be made. All data are anonymised
      when reported, and subject to the Official Secrets Health Acts. The test leaders are
      independent and blinded for randomisation. Exercises, both general and neck-specific, have
      been used extensively in clinical practice and we anticipate no harm from their
      implementation other than a risk of muscle soreness. Any important harms or unintended
      effects in each group will be collected by the test leaders. All questionnaires and test
      materials are encoded by the research group, with code lists stored in locked, fireproof file
      cabinets, housed at the university in a room with controlled (card-based) access. Only
      individuals in receipt of a unique website address posted by the researchers can access the
      program; patients can neither communicate with each other nor with caregivers via the
      program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Single Blind (Outcomes Assessor)
measure: Neck Disability Index (NDI)
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up. Preoperative data from the Swespine register
description: Self-reported neck-specific function
measure: Pain intensities of the neck, arm, and head, measured using the Visual Analogue Scale (VAS 0-100 mm).
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up. Pre-operative data from the Swespine register
description: Pain intensity VAS
measure: Pain intensities for the neck and arm will be assessed and registered using the Numeric Rating Scale (NRS) 0-10 scale in accordance with the Swespine registry
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Pain intensity NRS
measure: Distribution of pain by a Pain Drawing assessed with images
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: painful areas are shaded on a human body image
measure: Use of pain medications
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Use of pain medications
measure: Modified Odom
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: global outcomes of the intervention
measure: Dizziness/balance by the Dizziness Handicap Inventory (DHI)
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Self-reported dizziness
measure: Headache questions by VAS and the Headache Handicap Inventory (HIT-6)
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Impact of headache
measure: Disaster thoughts measured by the Pain Catastrophising Scale (PCS).
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Disaster thoughts
measure: Confidence in ability measured by the Self-Efficacy Scale (SES).
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Confidence in ability
measure: Patient Specific Functional Scale (PSFS).
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Estimation of neck-specific function related to participants' chosen activities (daily function, work, spare time
measure: Fear Avoidance Beliefs Questionnaire (FABQ).
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Operating fear
measure: Hospital Anxiety and Depression Scale (HAD).
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Self-reported anxiety and depression
measure: Health related quality of life measured by the EuroQuol five dimensions (EQ-5D)
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Health related quality of life
measure: Work Ability Index (WAI), short form
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Self-rated work ability
measure: Requirements - effort support in the workplace: Effort Reward Imbalance (ERI)
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: effort and support in the workplace
measure: Ergonomics questions and how work is perceived
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Work ergonomics
measure: Sickness presence measured by the Stanford preseenteism scale
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Sickness presence at work
measure: Swedish Standard Classification of Occupations (SSY) code
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Classification of Occupations
measure: Patient Enablement Instrument (PEI) questionnaire
time frame: Follow-up at 3 months (the end of treatment) and 24 months follow-up
description: Patient Enablement
measure: Satisfaction with symptoms measured by the Cherkin symptom satisfaction scale
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Satisfaction with symptoms
measure: Level of physical activity score, a combination of 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 24 months 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 24 months follow-up
description: Health-care consumption
measure: Consumption of analgesic drugs prescribed through the drug registry
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Consumption of analgesic drugs
measure: Frequency of pain
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Frequency of pain
measure: Sick-leave registration, number of days and episodes
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Sick-leave registration
measure: Neck movement measured using the cervical range of motion device (CROM) in degrees
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Active range of motion
measure: Endurance in the dorsal and ventral neck muscles, measured in seconds
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Neck muscle endurance
measure: Sensorimotor control of ventral neck muscles, in the supine position, with stabilizer (mm HG)
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Sensorimotor control
measure: Neurology, clinical judgement yes/no
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Neurology, such as reflexes, sensibility, muscle weakness and neural tension test. The results of the neurological examination gives an overall clinical judgement if segmental neurological findings is present and which cervical segmental level/ - is involved,
measure: Hand strength measured with a hand dynamometer (Jamar)
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Hand strength
measure: Standing on one leg with eyes closed (Solec test)
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Static balance
measure: Conventional radiography, with side views taken during neutral positioning and dynamic flexion/extension
time frame: Occurs routinely in the clinic for visits 3 months after surgery. Additional X-rays will be taken at the 2-year follow up to
description: Examination of implants, the degree of mobility of operated segments, subsidence and fusion
measure: Register data for care use. To measure/monitor care use
time frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up
description: Care use
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: 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: Global rating of change scale
time frame: Change from baseline to 3 and 24 months follow-ups, measured at follow-ups
description: Overall change because of the treatment
measure: Background data such as age and gender
time frame: Baseline
description: Background data such as age, gender, living circumstances and earlier care
arm group label: Prescribed Physical Activity
arm group type: Active Comparator
description: General physical exercises combined with 3 visits at a physiotherapy clinic (plus an additional first visit), exercises mainly performed outside the health care system during 12 weeks.
arm group label: Exercises with Internet support
arm group type: Experimental
description: Neck-specific exercises 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: Prescribed Physical Activity
description: General physical activity prescribed by a physiotherapist
arm group label: Prescribed Physical Activity
intervention type: Other
intervention name: Exercises with Internet support
description: Neck-specific exercise with Internet support
arm group label: Exercises with Internet support
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 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: Anneli Peolsson, Professor
phone: +46-13284601
email: Anneli.Peolsson@liu.se
last name: Håkan Löfgren, PhD, MD
phone: +46-102410000
email: Hakan.Lofgren@rjl.se
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Anneli Peolsson
investigator title: Professor, PhD, PT
mesh term: Intervertebral Disc Displacement
mesh term: Intervertebral Disc Degeneration
mesh term: Radiculopathy
sharing ipd: No