Chronic Neck Pain
Conditions
Keywords
Neck Pain, Disability Evaluation, Costs and Cost Analysis, Doin Exercise Therapy, Acupuncture
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.
Interventions
PROCEDUREDoin (conduction exercise)
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.
DEVICEAcupuncture
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.
Sponsors
Jaseng Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Northwick Park Neck Pain Questionnaire (NPQ) | 6 weeks from baseline | Change in pain and functional disability questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scale (NRS) of neck and arm pain | Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 | Pain scale |
| Visual analogue scale (VAS) of neck and arm pain | Baseline (Week 1), Week 2, 3, 4, 5, 6 | Pain scale |
| Neck Disability Index (NDI) | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 | Functional disability questionnaire |
| EuroQol-5 Dimension (EQ-5D) | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 | Health-related quality of life questionnaire |
| Patient Global Impression of Change (PGIC) | Week 4, 6, 9, 17, 29, 53 | Global, patient-reported outcome |
| Northwick Park Neck Pain Questionnaire (NPQ) | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 | Pain and functional disability questionnaire |
| Cost per QALY (quality-adjusted life year) | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 | Economic evaluation |
| Cost per NRS | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 | Economic evaluation |
| Drug Consumption | Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit) | Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments (e.g. physical therapy, injection therapy) |
| Adverse events | Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit) | Safety outcome |
| Short Form Health Survey 12 (SF-12) | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 | Health-related quality of life questionnaire |
Countries
South Korea
Outcome results
None listed