Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain

Jaseng Medical Foundation

Status: Completed

Conditions: Chronic Neck Pain

Treatments: Device: Acupuncture; Procedure: Doin (conduction exercise)

Study type: Interventional

Funder types: Other

Identifiers

NCT03009071

JS-CT-2016-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Doin with Acupuncture

Experimental group

Description:

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.

Treatment:

Device: Acupuncture

Procedure: Doin (conduction exercise)

Acupuncture

Active Comparator group

Description:

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).

Treatment:

Device: Acupuncture