<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/NCT03294785</url>
  </required_header>
  <id_info>
    <org_study_id>JS-CT-2016-14</org_study_id>
    <nct_id>NCT03294785</nct_id>
  </id_info>
  <brief_title>Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain</brief_title>
  <official_title>Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain: A Multi-center Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaseng Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kyung Hee University Hospital at Gangdong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Michigan State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jaseng Medical Foundation</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>
      A multi-center randomized controlled trial assessing the comparative effectiveness and&#xD;
      cost-effectiveness of Chuna manual therapy for chronic neck pain&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multi-center randomized controlled, parallel, assessor-blinded trial will be conducted to&#xD;
      evaluate the comparative clinical effectiveness and cost-effectiveness of Chuna manual&#xD;
      therapy for chronic neck pain patients compared to usual care as assessed using pain,&#xD;
      functional disability, health-related quality of life, economic evaluation, and safety&#xD;
      measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2017</start_date>
  <completion_date type="Actual">June 28, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</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>Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline</measure>
    <time_frame>Week 5 post-baseline (screening)</time_frame>
    <description>VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference between visual analogue scale (VAS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively</measure>
    <time_frame>Week 1, 2, 3, 4, 5, 6 post-baseline (screening)</time_frame>
    <description>VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between numeric rating scale (NRS) of neck pain for the past 3 days at each timepoint and baseline, respectively</measure>
    <time_frame>Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)</time_frame>
    <description>In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between numeric rating scale (NRS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively</measure>
    <time_frame>Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)</time_frame>
    <description>In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between Neck Disability Index (NDI) at each timepoint and baseline, respectively</measure>
    <time_frame>Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)</time_frame>
    <description>The NDI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to neck pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between Northwick Park Neck Pain Questionnaire (NPQ) at each timepoint and baseline, respectively</measure>
    <time_frame>Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)</time_frame>
    <description>The NPQ evaluates functional impairment for the past 3 days in this study and is a patient reported outcome of subjective neck pain and pain reduction. The NPQ is a 9-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 5 levels, each representing a score of 0-4. Higher scores indicate greater limitation relating to neck pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC)</measure>
    <time_frame>Week 6, Month 3, 6, 9, 12 post-baseline (screening)</time_frame>
    <description>PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical examination</measure>
    <time_frame>Week 1, 6 post-baseline (screening)</time_frame>
    <description>Pain upon movement in cervical range of motion (ROM) will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between the 5 level version of EuroQol-5 Dimension (EQ-5D-5L) at each timepoint and baseline, respectively</measure>
    <time_frame>Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)</time_frame>
    <description>EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively</measure>
    <time_frame>Week 1, 6 post-baseline (screening)</time_frame>
    <description>EQ-VAS uses a vertical 10cm line labeled at each end with scale anchors. EQ-VAS is used to indicate the patient's health state and patients are asked to mark a point that represents their health state between the anchors of 'worst health state' and 'best health state imaginable'. Scores are recorded in millimeters with a total range of 0-100 millimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between the Short Form Health Survey 12 (SF-12) at each timepoint and baseline, respectively</measure>
    <time_frame>Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)</time_frame>
    <description>SF-12 is a simplified version of SF-36. SF-12 assesses health-related quality of life (HRQoL) across 8 domains with 1-2 items per domain: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Higher scores indicate better HRQoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic evaluation (medical costs)</measure>
    <time_frame>Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)</time_frame>
    <description>Economic evaluation of medical costs will be performed to assess cost-effectiveness of the 2 groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic evaluation (time-related costs)</measure>
    <time_frame>Week 2 post-baseline (screening)</time_frame>
    <description>Economic evaluation of time-related costs will be performed to assess cost-effectiveness of the 2 groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic evaluation (lost productivity costs)</measure>
    <time_frame>Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)</time_frame>
    <description>Economic evaluation of lost productivity costs will be performed to assess cost-effectiveness of the 2 groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Credibility and Expectancy Questionnaire</measure>
    <time_frame>Week 1 post-baseline (screening)</time_frame>
    <description>The credibility and expectancy questionnaire will be used to assess treatment expectation on a 9-point Likert scale. Participants will be asked to select an answer to the following questions on their first visit of Week 1 (1='not at all'; and 5='somewhat'; to 9='very much'): &quot;How much do you expect that treatment will alleviate your symptoms during the study period?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug Consumption</measure>
    <time_frame>Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)</time_frame>
    <description>Drug type and dose of prescription for medicine or rescue medicine (acetaminophen), and type and frequency of other treatments (e.g. physical therapy, injections) will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening) (every visit)</time_frame>
    <description>Physicians will monitor and record any unexpected or unintended patient reaction to Chuna or usual care at each visit. Adverse events (AEs) associated with Chuna will include, but not be limited to, AEs anticipated from previous reports of manual therapy, and will stay open to all possibilities taking into consideration other potential, unknown AEs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Chronic Neck Pain</condition>
  <arm_group>
    <arm_group_label>Chuna manual therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Chuna manual therapy group will receive Chuna manual therapy alone. Chuna manual therapy will employ a semi-standardized treatment plan of Chuna manual therapy through Chuna technique selection based on physician judgement of techniques from Chuna Medicine (Korean Society of Chuna Manual Medicine for Spine &amp; Nerves: Chuna Medicine: Seoul: Korean Society of Chuna Manual Medicine for Spine &amp; Nerves; 2017) and osteopathic manipulative medicine. The Chuna techniques employed in this study are divided into cervical, thoracic and rib cage, lumbar, pelvic, sacral, pubic, and hip joint area techniques. Chuna manual therapy sessions will be administered 2 sessions/week over a period of 5 weeks (total 10 sessions). The time duration of 1 Chuna manual therapy session will consist of approximately 10-20 minutes of diagnosis and approximately 10 minutes of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The usual care group will receive usual care alone. Usual care will be limited to physical therapy and conventional medication in this study. Usual care will be provided with reference to a list of most frequently used treatments in neck pain-related patients from Korean Health Insurance Review and Assessment (HIRA) 2014 statistics. Frequency and types of physical therapy used will be recorded in a separate electronic case report form for outcome assessor blinding purposes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Chuna manual therapy</intervention_name>
    <description>Chuna is a Korean manual therapy that has absorbed and incorporated aspects of osteopathic manipulative medicine. Chuna manual therapy utilizes spinal manipulation techniques for joint mobilization including high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement, muscle energy, and fascial techniques.</description>
    <arm_group_label>Chuna manual therapy</arm_group_label>
    <other_name>Chuna manipulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Conventional medication</intervention_name>
    <description>Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of cervical sprain/strain group, cervical disc disorder with radiculopathy group, or cervicalgia according to Korean Health Insurance Review and Assessment (HIRA) 2014 statistics.</description>
    <arm_group_label>Usual care</arm_group_label>
    <other_name>Conventional medicine</other_name>
    <other_name>Conventional drugs</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physical therapy</intervention_name>
    <description>Physical therapy will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of cervical sprain/strain group, cervical disc disorder with radiculopathy group, or cervicalgia according to Korean Health Insurance Review and Assessment (HIRA) 2014 statistics.</description>
    <arm_group_label>Usual care</arm_group_label>
    <other_name>Physiotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic neck pain patients (with pain duration of 3 months or longer)&#xD;
&#xD;
          -  Patients with numeric rating scale (NRS) of radicular pain ≤ neck pain in neck pain&#xD;
             patients with or without radiculopathy&#xD;
&#xD;
          -  Patients with NRS of neck pain ≥5 during the 3 days&#xD;
&#xD;
          -  Patients who have agreed to trial participation and provided written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. spinal&#xD;
             metastasis of tumor(s), acute fracture, spinal dislocation)&#xD;
&#xD;
          -  Patients with history of neck surgery&#xD;
&#xD;
          -  Patients with other chronic disease(s) which may interfere with treatment effect,&#xD;
             safety, or interpretation of outcomes (e.g. chronic renal failure, vertebral artery&#xD;
             complications, rheumatoid arthritis, Down syndrome)&#xD;
&#xD;
          -  Patients with progressive neurologic deficit or severe neurologic symptoms such as&#xD;
             spinal cord injury&#xD;
&#xD;
          -  Patients with severe mental illness&#xD;
&#xD;
          -  Patients currently taking steroids, immunosuppressants, medicine for mental illness or&#xD;
             other medication(s) that may interfere with study results&#xD;
&#xD;
          -  Patients who have received Chuna manual therapy or physical therapy, medicine such as&#xD;
             nonsteroidal anti-inflammatory drugs (NSAIDs), or treatment(s) that may influence pain&#xD;
             within the past week&#xD;
&#xD;
          -  Pregnant patients or patients with plans of pregnancy&#xD;
&#xD;
          -  Patients participating in other clinical studies or otherwise deemed unsuitable by the&#xD;
             researchers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>In-Hyuk Ha, KMD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jaseng Medical Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bucheon Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Bucheon</city>
        <state>Gyeonggi</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haeundae Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daejeon Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>06110</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyung Hee University Oriental Medicine Hospital at Gangdong</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>July 31, 2019</last_update_submitted>
  <last_update_submitted_qc>July 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jaseng Medical Foundation</investigator_affiliation>
    <investigator_full_name>In-Hyuk Ha, KMD</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck Pain</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/NCT03294785
org study id: JS-CT-2016-14
nct id: NCT03294785
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A multi-center randomized controlled trial assessing the comparative effectiveness and
      cost-effectiveness of Chuna manual therapy for chronic neck pain
A multi-center randomized controlled, parallel, assessor-blinded trial will be conducted to
      evaluate the comparative clinical effectiveness and cost-effectiveness of Chuna manual
      therapy for chronic neck pain patients compared to usual care as assessed using pain,
      functional disability, health-related quality of life, economic evaluation, and safety
      measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline
time frame: Week 5 post-baseline (screening)
description: VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
measure: Difference between visual analogue scale (VAS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
time frame: Week 1, 2, 3, 4, 5, 6 post-baseline (screening)
description: VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
measure: Difference between numeric rating scale (NRS) of neck pain for the past 3 days at each timepoint and baseline, respectively
time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
description: In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
measure: Difference between numeric rating scale (NRS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
description: In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
measure: Difference between Neck Disability Index (NDI) at each timepoint and baseline, respectively
time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
description: The NDI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to neck pain.
measure: Difference between Northwick Park Neck Pain Questionnaire (NPQ) at each timepoint and baseline, respectively
time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
description: The NPQ evaluates functional impairment for the past 3 days in this study and is a patient reported outcome of subjective neck pain and pain reduction. The NPQ is a 9-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 5 levels, each representing a score of 0-4. Higher scores indicate greater limitation relating to neck pain.
measure: Patient Global Impression of Change (PGIC)
time frame: Week 6, Month 3, 6, 9, 12 post-baseline (screening)
description: PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).
measure: Physical examination
time frame: Week 1, 6 post-baseline (screening)
description: Pain upon movement in cervical range of motion (ROM) will be assessed.
measure: Difference between the 5 level version of EuroQol-5 Dimension (EQ-5D-5L) at each timepoint and baseline, respectively
time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
description: EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem).
measure: Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively
time frame: Week 1, 6 post-baseline (screening)
description: EQ-VAS uses a vertical 10cm line labeled at each end with scale anchors. EQ-VAS is used to indicate the patient's health state and patients are asked to mark a point that represents their health state between the anchors of 'worst health state' and 'best health state imaginable'. Scores are recorded in millimeters with a total range of 0-100 millimeters.
measure: Difference between the Short Form Health Survey 12 (SF-12) at each timepoint and baseline, respectively
time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
description: SF-12 is a simplified version of SF-36. SF-12 assesses health-related quality of life (HRQoL) across 8 domains with 1-2 items per domain: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Higher scores indicate better HRQoL.
measure: Economic evaluation (medical costs)
time frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
description: Economic evaluation of medical costs will be performed to assess cost-effectiveness of the 2 groups.
measure: Economic evaluation (time-related costs)
time frame: Week 2 post-baseline (screening)
description: Economic evaluation of time-related costs will be performed to assess cost-effectiveness of the 2 groups.
measure: Economic evaluation (lost productivity costs)
time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
description: Economic evaluation of lost productivity costs will be performed to assess cost-effectiveness of the 2 groups.
measure: Credibility and Expectancy Questionnaire
time frame: Week 1 post-baseline (screening)
description: The credibility and expectancy questionnaire will be used to assess treatment expectation on a 9-point Likert scale. Participants will be asked to select an answer to the following questions on their first visit of Week 1 (1='not at all'; and 5='somewhat'; to 9='very much'): "How much do you expect that treatment will alleviate your symptoms during the study period?"
measure: Drug Consumption
time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
description: Drug type and dose of prescription for medicine or rescue medicine (acetaminophen), and type and frequency of other treatments (e.g. physical therapy, injections) will be recorded.
measure: Adverse events
time frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening) (every visit)
description: Physicians will monitor and record any unexpected or unintended patient reaction to Chuna or usual care at each visit. Adverse events (AEs) associated with Chuna will include, but not be limited to, AEs anticipated from previous reports of manual therapy, and will stay open to all possibilities taking into consideration other potential, unknown AEs.
arm group label: Chuna manual therapy
arm group type: Experimental
description: The Chuna manual therapy group will receive Chuna manual therapy alone. Chuna manual therapy will employ a semi-standardized treatment plan of Chuna manual therapy through Chuna technique selection based on physician judgement of techniques from Chuna Medicine (Korean Society of Chuna Manual Medicine for Spine & Nerves: Chuna Medicine: Seoul: Korean Society of Chuna Manual Medicine for Spine & Nerves; 2017) and osteopathic manipulative medicine. The Chuna techniques employed in this study are divided into cervical, thoracic and rib cage, lumbar, pelvic, sacral, pubic, and hip joint area techniques. Chuna manual therapy sessions will be administered 2 sessions/week over a period of 5 weeks (total 10 sessions). The time duration of 1 Chuna manual therapy session will consist of approximately 10-20 minutes of diagnosis and approximately 10 minutes of treatment.
arm group label: Usual care
arm group type: Active Comparator
description: The usual care group will receive usual care alone. Usual care will be limited to physical therapy and conventional medication in this study. Usual care will be provided with reference to a list of most frequently used treatments in neck pain-related patients from Korean Health Insurance Review and Assessment (HIRA) 2014 statistics. Frequency and types of physical therapy used will be recorded in a separate electronic case report form for outcome assessor blinding purposes.
intervention type: Procedure
intervention name: Chuna manual therapy
description: Chuna is a Korean manual therapy that has absorbed and incorporated aspects of osteopathic manipulative medicine. Chuna manual therapy utilizes spinal manipulation techniques for joint mobilization including high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement, muscle energy, and fascial techniques.
arm group label: Chuna manual therapy
other name: Chuna manipulation
intervention type: Drug
intervention name: Conventional medication
description: Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of cervical sprain/strain group, cervical disc disorder with radiculopathy group, or cervicalgia according to Korean Health Insurance Review and Assessment (HIRA) 2014 statistics.
arm group label: Usual care
other name: Conventional medicine
other name: Conventional drugs
intervention type: Procedure
intervention name: Physical therapy
description: Physical therapy will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of cervical sprain/strain group, cervical disc disorder with radiculopathy group, or cervicalgia according to Korean Health Insurance Review and Assessment (HIRA) 2014 statistics.
arm group label: Usual care
other name: Physiotherapy
criteria: 
gender: All
minimum age: 19 Years
maximum age: 60 Years
healthy volunteers: No
last name: In-Hyuk Ha, KMD, MPH
role: Principal Investigator
affiliation: Jaseng Medical Foundation
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Jaseng Medical Foundation
investigator full name: In-Hyuk Ha, KMD
investigator title: Director
mesh term: Neck Pain
sharing ipd: No