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

NCT03294785 | Completed

• 1 other identifier: JS-CT-2016-14
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Chronic Neck Pain

Outcome Measures

Primary Outcomes (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.

  Week 5 post-baseline (screening)

Secondary Outcomes (16)

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

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

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

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

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

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

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

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

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

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

Study Arms (2)

Chuna manual therapy

EXPERIMENTAL

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.

Procedure: Chuna manual therapy

Usual care

ACTIVE COMPARATOR

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.

Drug: Conventional medication; Procedure: Physical therapy

Interventions

Chuna manual therapy PROCEDURE

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.

Also known as: Chuna manipulation

Chuna manual therapy

Conventional medication DRUG

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.

Also known as: Conventional medicine, Conventional drugs

Usual care

Physical therapy PROCEDURE

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.

Also known as: Physiotherapy

Usual care

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead
• Kyung Hee University Hospital at Gangdong: collaborator
• Michigan State University: collaborator

Study Sites (5)

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi-do, South Korea

Location

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

Location

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, South Korea

Location

Jaseng Hospital of Korean Medicine

Seoul, 06110, South Korea

Location

Kyung Hee University Oriental Medicine Hospital at Gangdong

Seoul, South Korea

Location

Related Publications (2)

• 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.

  PMID: 34259850 DERIVED

• 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.

  PMID: 30497483 DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• In-Hyuk Ha, KMD, MPH

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 23, 2017
• First Posted: September 27, 2017
• Study Start: October 18, 2017
• Primary Completion: August 1, 2018
• Study Completion: June 28, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)