The 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 with acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03558178

JS-CT-2018-03

Details and patient eligibility

About

A multi-center randomized controlled trial assessing the comparative effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain

Full description

A multi-center randomized controlled, parallel, assessor-blinded full-scale trial will be conducted based on the results of the pilot study to evaluate the comparative clinical effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain patients compared to acupuncture alone as assessed using pain, functional disability, health-related quality of life, economic evaluation, and safety measures.

Enrollment: 124 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Neck area pain duration of 6 months or longer
• Current Numeric Rating Scale (NRS) for neck area pain of 5 or higher
• Patients who have agreed to voluntarily participate in the clinical trial and given written informed consent

Exclusion criteria

• Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. malignant tumor, spinal infection, inflammatory spondylitis)
• Progressive neurologic deficit or severe neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness)
• 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)
• 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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124 participants in 2 patient groups

Doin with Acupuncture

Experimental group

Description:

An acupuncture physician will administer acupuncture at a total 6-12 acupoints in the upper and middle trapezius areas (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 as indicated.

Treatment:

Procedure: Doin with acupuncture

Device: Acupuncture

Acupuncture

Active Comparator group

Description:

An acupuncture physician will administer acupuncture at a total 6-12 acupoints in the upper and middle trapezius areas (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