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Chronic Neck PainNCT03294785

Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain

A study testing Chuna manual therapy, Conventional medication and Physical therapy in people with Chronic Neck Pain, run by Jaseng Medical Foundation at 5 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A multi-center randomized controlled trial assessing the comparative effectiveness and cost-effectiveness of Chuna manual therapy for chronic neck pain Read more about this study

Who is it for?
Ages 19 to 60 years
Conditions the study is for
Chronic Neck Pain
What is being tested?
Chuna manual therapy, Conventional medication and Physical therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
5 sitesSouth Korea
Study dates
18 Oct 2017to 28 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

South Korea5 sites
  • Bucheon Jaseng Hospital of Korean Medicine

    Bucheon-si, Gyeonggi-do

  • Haeundae Jaseng Hospital of Korean Medicine

    Busan

  • Daejeon Jaseng Hospital of Korean Medicine

    Daejeon

  • Jaseng Hospital of Korean Medicine

    Seoul, 06110

  • Kyung Hee University Oriental Medicine Hospital at Gangdong

    Seoul

Other trials in South Korea

About this study

Official title: 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

Read the 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.

Being tested
Chuna manual therapy, Conventional medication, Physical therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chuna manual therapyProcedure or surgery

    Also called Chuna manipulation

    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.

  • Conventional medicationDrug

    Also called Conventional medicine, Conventional drugs

    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.

  • Physical therapyProcedure or surgery

    Also called Physiotherapy

    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.

Study groups in NCT03294785
Study groupRoleWhat they receive
Chuna manual therapyExperimentalThe 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.
Receives: Procedure: Chuna manual therapy
Usual careActive comparatorThe 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.
Receives: Drug: Conventional medication; Procedure: Physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline

    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.

    Measured: Week 5 post-baseline (screening)

Secondary outcomes (16)
  1. Difference between visual analogue scale (VAS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively

    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.

    Measured: Week 1, 2, 3, 4, 5, 6 post-baseline (screening)

  2. Difference between numeric rating scale (NRS) of neck pain for the past 3 days at each timepoint and baseline, respectively

    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'.

    Measured: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)

  3. Difference between numeric rating scale (NRS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively

    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'.

    Measured: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)

  4. Difference between Neck Disability Index (NDI) at each timepoint and baseline, respectively

    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.

    Measured: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)

  5. Difference between Northwick Park Neck Pain Questionnaire (NPQ) at each timepoint and baseline, respectively

    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.

    Measured: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)

  6. Patient Global Impression of Change (PGIC)

    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).

    Measured: Week 6, Month 3, 6, 9, 12 post-baseline (screening)

  7. Physical examination

    Pain upon movement in cervical range of motion (ROM) will be assessed.

    Measured: Week 1, 6 post-baseline (screening)

  8. Difference between the 5 level version of EuroQol-5 Dimension (EQ-5D-5L) at each timepoint and baseline, respectively

    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).

    Measured: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)

  9. Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively

    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.

    Measured: Week 1, 6 post-baseline (screening)

  10. Difference between the Short Form Health Survey 12 (SF-12) at each timepoint and baseline, respectively

    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.

    Measured: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)

  11. Economic evaluation (medical costs)

    Economic evaluation of medical costs will be performed to assess cost-effectiveness of the 2 groups.

    Measured: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)

  12. Economic evaluation (time-related costs)

    Economic evaluation of time-related costs will be performed to assess cost-effectiveness of the 2 groups.

    Measured: Week 2 post-baseline (screening)

  13. Economic evaluation (lost productivity costs)

    Economic evaluation of lost productivity costs will be performed to assess cost-effectiveness of the 2 groups.

    Measured: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)

  14. Credibility and Expectancy Questionnaire

    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?"

    Measured: Week 1 post-baseline (screening)

  15. Drug Consumption

    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.

    Measured: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)

  16. Adverse events

    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.

    Measured: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening) (every visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2017
  2. Study start18 Oct 2017
  3. Primary completion1 Aug 2018
  4. Study completion28 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03294785
Sponsor's protocol ID
JS-CT-2016-14
Status last verified
Jul 2019
First submitted
23 Sep 2017
Last updated
2 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34259850
  • 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.

    PubMed 30497483

Questions about this trial

What is this clinical trial studying?

A study testing Chuna manual therapy, Conventional medication and Physical therapy in people with Chronic Neck Pain, run by Jaseng Medical Foundation at 5 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03294785, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019; AzTrials last refreshed its copy on 2 Nov 2026.

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