- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03294785
Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain
July 31, 2019 updated by: In-Hyuk Ha, KMD, Jaseng Medical Foundation
Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain: A Multi-center Randomized Controlled Trial
A multi-center randomized controlled trial assessing the comparative effectiveness and cost-effectiveness of Chuna manual therapy for chronic neck pain
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Busan, Korea, Republic of
- Haeundae Jaseng Hospital of Korean Medicine
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Daejeon, Korea, Republic of
- Daejeon Jaseng Hospital of Korean Medicine
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Seoul, Korea, Republic of, 06110
- Jaseng Hospital of Korean Medicine
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Seoul, Korea, Republic of
- Kyung Hee University Oriental Medicine Hospital at Gangdong
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Gyeonggi
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Bucheon, Gyeonggi, Korea, Republic of
- Bucheon Jaseng Hospital of Korean Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic neck pain patients (with pain duration of 3 months or longer)
- Patients with numeric rating scale (NRS) of radicular pain ≤ neck pain in neck pain patients with or without radiculopathy
- Patients with NRS of neck pain ≥5 during the 3 days
- Patients who have agreed to trial participation and provided written informed consent
Exclusion Criteria:
- Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. spinal metastasis of tumor(s), acute fracture, spinal dislocation)
- Patients with history of neck surgery
- Patients with other chronic disease(s) which may interfere with treatment effect, safety, or interpretation of outcomes (e.g. chronic renal failure, vertebral artery complications, rheumatoid arthritis, Down syndrome)
- Patients with progressive neurologic deficit or severe neurologic symptoms such as spinal cord injury
- Patients with severe mental illness
- Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
- Patients who have received Chuna manual therapy or physical therapy, medicine such as nonsteroidal anti-inflammatory drugs (NSAIDs), or treatment(s) that may influence pain within the past week
- Pregnant patients or patients with plans of pregnancy
- Patients participating in other clinical studies or otherwise deemed unsuitable by the researchers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Chuna manual therapy
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.
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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.
Other Names:
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ACTIVE_COMPARATOR: Usual care
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.
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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.
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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Week 5 post-baseline (screening)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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Week 1, 2, 3, 4, 5, 6 post-baseline (screening)
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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)
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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'.
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Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
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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)
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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'.
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Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
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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)
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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.
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Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
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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)
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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.
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Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
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Patient Global Impression of Change (PGIC)
Time Frame: Week 6, Month 3, 6, 9, 12 post-baseline (screening)
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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).
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Week 6, Month 3, 6, 9, 12 post-baseline (screening)
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Physical examination
Time Frame: Week 1, 6 post-baseline (screening)
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Pain upon movement in cervical range of motion (ROM) will be assessed.
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Week 1, 6 post-baseline (screening)
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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)
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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).
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Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
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Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively
Time Frame: Week 1, 6 post-baseline (screening)
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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.
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Week 1, 6 post-baseline (screening)
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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)
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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.
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Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
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Economic evaluation (medical costs)
Time Frame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
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Economic evaluation of medical costs will be performed to assess cost-effectiveness of the 2 groups.
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Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
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Economic evaluation (time-related costs)
Time Frame: Week 2 post-baseline (screening)
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Economic evaluation of time-related costs will be performed to assess cost-effectiveness of the 2 groups.
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Week 2 post-baseline (screening)
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Economic evaluation (lost productivity costs)
Time Frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
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Economic evaluation of lost productivity costs will be performed to assess cost-effectiveness of the 2 groups.
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Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
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Credibility and Expectancy Questionnaire
Time Frame: Week 1 post-baseline (screening)
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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?"
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Week 1 post-baseline (screening)
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Drug Consumption
Time Frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
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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.
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Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
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Adverse events
Time Frame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening) (every visit)
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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.
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Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening) (every visit)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lee J, Cho JH, Kim KW, Lee JH, Kim MR, Kim J, Kim MY, Cho HW, Lee YJ, Lee SH, Shin JS, Prokop LL, Shin BC, Ha IH. Chuna Manual Therapy vs Usual Care for Patients With Nonspecific Chronic Neck Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2113757. doi: 10.1001/jamanetworkopen.2021.13757.
- Do HJ, Shin JS, Lee J, Lee YJ, Kim MR, Cho JH, Kim KW, Ha IH. Comparative effectiveness and economic evaluation of Chuna manual therapy for chronic neck pain: protocol for a multicenter randomized controlled trial. Trials. 2018 Nov 29;19(1):663. doi: 10.1186/s13063-018-3016-6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 18, 2017
Primary Completion (ACTUAL)
August 1, 2018
Study Completion (ACTUAL)
June 28, 2019
Study Registration Dates
First Submitted
September 23, 2017
First Submitted That Met QC Criteria
September 23, 2017
First Posted (ACTUAL)
September 27, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 2, 2019
Last Update Submitted That Met QC Criteria
July 31, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JS-CT-2016-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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