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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Doin (conduction exercise) will be combined with acupuncture as active and passive movement to the aim of effective treatment of pain and functional disability. Doin (conduction exercise) sessions will be conducted 2 times a week for 5 weeks.
Acupuncture will be performed with manual stimulation (needle twirling) to evoke de-qi sensation. Acupuncture sessions will be conducted 2 times a week for 5 weeks.
Jaseng Medical Foundation
Seoul, South Korea
Change in Northwick Park Neck Pain Questionnaire (NPQ)
Change in pain and functional disability questionnaire
Time frame: 6 weeks from baseline
Northwick Park Neck Pain Questionnaire (NPQ)
Pain and functional disability questionnaire
Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Numeric rating scale (NRS) of neck and arm pain
Pain scale
Time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53
Visual analogue scale (VAS) of neck and arm pain
Pain scale
Time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6
Neck Disability Index (NDI)
Functional disability questionnaire
Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
EuroQol-5 Dimension (EQ-5D)
Health-related quality of life questionnaire
Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Patient Global Impression of Change (PGIC)
Global, patient-reported outcome
Time frame: Week 4, 6, 9, 17, 29, 53
Short Form Health Survey 12 (SF-12)
Health-related quality of life questionnaire
Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
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Cost per QALY (quality-adjusted life year)
Economic evaluation
Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Cost per NRS
Economic evaluation
Time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Drug Consumption
Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments (e.g. physical therapy, injection therapy)
Time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
Adverse events
Safety outcome
Time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)