Clinical trial NCT03294785: Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain
Official title: Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain: A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
Collaborators: name: Kyung Hee University Hospital at Gangdong
name: Michigan State University
First posted: 2017-09-27
Enrollment: 108
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline
timeFrame: Week 5 post-baseline (screening)
Secondary outcomes:
measure: Difference between visual analogue scale (VAS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
timeFrame: Week 1, 2, 3, 4, 5, 6 post-baseline (screening)
measure: Difference between numeric rating scale (NRS) of neck pain for the past 3 days at each timepoint and baseline, respectively
timeFrame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
measure: Difference between numeric rating scale (NRS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
timeFrame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
measure: Difference between Neck Disability Index (NDI) at each timepoint and baseline, respectively
timeFrame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
measure: Difference between Northwick Park Neck Pain Questionnaire (NPQ) at each timepoint and baseline, respectively
timeFrame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 6, Month 3, 6, 9, 12 post-baseline (screening)
measure: Physical examination
timeFrame: Week 1, 6 post-baseline (screening)
measure: Difference between the 5 level version of EuroQol-5 Dimension (EQ-5D-5L) at each timepoint and baseline, respectively
timeFrame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
measure: Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively
timeFrame: Week 1, 6 post-baseline (screening)
measure: Difference between the Short Form Health Survey 12 (SF-12) at each timepoint and baseline, respectively
timeFrame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
measure: Economic evaluation (medical costs)
timeFrame: Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
measure: Economic evaluation (time-related costs)
timeFrame: Week 2 post-baseline (screening)
measure: Economic evaluation (lost productivity costs)
timeFrame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
measure: Credibility and Expectancy Questionnaire
timeFrame: Week 1 post-baseline (screening)
measure: Drug Consumption
timeFrame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
measure: Adverse events
timeFrame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening) (every visit)
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon Jaseng Hospital of Korean Medicine
state: Gyeonggi
city: Busan
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Oriental Medicine Hospital at Gangdong
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, KMD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.