Clinical trial NCT03558178: The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain
Official title: The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) 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
First posted: 2018-06-15
Enrollment: 124
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_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 Doin (conduction exercise) with acupuncture for chronic neck pain

Detailed description: A multi-center randomized controlled, parallel, assessor-blinded full-scale trial will be conducted based on the results of the pilot study to evaluate the comparative clinical effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain patients compared to acupuncture alone as assessed using pain, functional disability, health-related quality of life, economic evaluation, and safety measures.

Eligibility criteria: Inclusion Criteria:

* Neck area pain duration of 6 months or longer
* Current Numeric Rating Scale (NRS) for neck area pain of 5 or higher
* Patients who have agreed to voluntarily participate in the clinical trial and given written informed consent

Exclusion Criteria:

* Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. malignant tumor, spinal infection, inflammatory spondylitis)
* Progressive neurologic deficit or severe neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness)
* Pathologies of non-spinal or soft tissue origin or high severity which may cause neck or radiating arm pain (e.g. malignant tumor, spinal infection, inflammatory spondylitis, fibromyalgia, rheumatic arthritis, gout)
* Other chronic diseases which may interfere with treatment effect or interpretation of results (e.g. cardiovascular disorder, renal disease, diabetic neuropathy, dementia, epilepsy)
* Current intake of steroids, immunosuppressant medicine, psychiatric medicine or other medication which may interfere with treatment results
* Patients considered unsuitable or unsafe to receive acupuncture (e.g. patients with hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, severe diabetes with high risk of infection, severe cardiovascular diseases)
* Patients who were treated with invasive interventions such as acupuncture or injections, or with medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs) within the past week
* History of cervical surgery within the past 3 months
* Pregnancy or plans of pregnancy
* Severe psychopathy
* Participation in other clinical studies
* Inability to give written informed consent
* Other reasons rendering trial participation inappropriate as judged 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, Month 3, 6, 9, 12 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 (drug type)
timeFrame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
measure: Drug Consumption (drug dose)
timeFrame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
measure: Other treatments (treatment type)
timeFrame: Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
measure: Other treatments (treatment frequency)
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, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee SH, Lee J, Lee YJ, Kim MR, Cho JH, Kim KW, Ha IH. Effectiveness and cost-effectiveness of acupuncture with Doin therapy for chronic neck pain: a study protocol for a multicentre, randomised controlled clinical trial. BMJ Open. 2019 May 10;9(5):e026632. doi: 10.1136/bmjopen-2018-026632.