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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doin with Acupuncture | Experimental | An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels). Cervical Doin (conduction exercise) will be performed with the needles in situ by increasing the cervical range of motion (rotation) with physician guidance and isometric resistance exercise (rotation) as needed. |
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| Acupuncture | Active Comparator | An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doin (conduction exercise) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Northwick Park Neck Pain Questionnaire (NPQ) | Change in pain and functional disability questionnaire | 6 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Northwick Park Neck Pain Questionnaire (NPQ) | Pain and functional disability questionnaire | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 |
| Numeric rating scale (NRS) of neck and arm pain | Pain scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Hyuk Ha, KMD, MPH | Jaseng Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaseng Medical Foundation | Seoul | South Korea |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Acupuncture | Device | 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. |
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| Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 |
| Visual analogue scale (VAS) of neck and arm pain | Pain scale | Baseline (Week 1), Week 2, 3, 4, 5, 6 |
| Neck Disability Index (NDI) | Functional disability questionnaire | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 |
| EuroQol-5 Dimension (EQ-5D) | Health-related quality of life questionnaire | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 |
| Patient Global Impression of Change (PGIC) | Global, patient-reported outcome | Week 4, 6, 9, 17, 29, 53 |
| Short Form Health Survey 12 (SF-12) | Health-related quality of life questionnaire | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 |
| Cost per QALY (quality-adjusted life year) | Economic evaluation | Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 |
| Cost per NRS | Economic evaluation | 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) | Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit) |
| Adverse events | Safety outcome | Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit) |