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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-06

Study Completion Date

2019-12-05

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Doin with Acupuncture

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.

Group Type EXPERIMENTAL

Doin with acupuncture

Intervention Type PROCEDURE

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. Doin sessions will be conducted 2 times a week for 5 weeks (total 10 sessions).

Acupuncture

Intervention Type 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 (total 10 sessions).

Acupuncture

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).

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type 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 (total 10 sessions).

Interventions

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Doin with acupuncture

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. Doin sessions will be conducted 2 times a week for 5 weeks (total 10 sessions).

Intervention Type PROCEDURE

Acupuncture

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 (total 10 sessions).

Intervention Type DEVICE

Other Intervention Names

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Doin Exercise with acupuncture Do-in Exercise with acupuncture Conduction Exercise with acupuncture

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No