Clinical trial NCT03009071: 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 Pilot Multicenter Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Keywords: Neck Pain
Disability Evaluation
Costs and Cost Analysis
Doin Exercise Therapy
Acupuncture
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 30
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 pilot multicenter randomized controlled trial will be conducted to evaluate the clinical effectiveness, cost-effectiveness, and safety of Doin (conduction exercise) with acupuncture for chronic neck pain patients compared to acupuncture alone.

Detailed description: A pilot multicenter randomized controlled, parallel, assessor-blinded trial will be conducted to evaluate the comparative clinical effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain patients with acupuncture alone as assessed by pain and functional disability scales, monitor its safety, and assess the feasibility of and serve as the basis for a full-scale, multicenter trial.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)
* Progressive neurologic deficit or severe neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness)
* 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: Change in Northwick Park Neck Pain Questionnaire (NPQ)
timeFrame: 6 weeks from baseline
Secondary outcomes:
measure: Northwick Park Neck Pain Questionnaire (NPQ)
timeFrame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
measure: Numeric rating scale (NRS) of neck and arm pain
timeFrame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53
measure: Visual analogue scale (VAS) of neck and arm pain
timeFrame: Baseline (Week 1), Week 2, 3, 4, 5, 6
measure: Neck Disability Index (NDI)
timeFrame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
measure: EuroQol-5 Dimension (EQ-5D)
timeFrame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 4, 6, 9, 17, 29, 53
measure: Short Form Health Survey 12 (SF-12)
timeFrame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
measure: Cost per QALY (quality-adjusted life year)
timeFrame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
measure: Cost per NRS
timeFrame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
measure: Drug Consumption
timeFrame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
measure: Adverse events
timeFrame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Medical Foundation
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, KMD, MPH
role: PRINCIPAL_INVESTIGATOR
References: