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

NCT03009071 | Completed

• 1 other identifier: JS-CT-2016-18
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Neck Pain

Keywords

Neck Pain; Disability Evaluation; Costs and Cost Analysis; Doin Exercise Therapy; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Change in Northwick Park Neck Pain Questionnaire (NPQ)

  Change in pain and functional disability questionnaire

  6 weeks from baseline

Secondary Outcomes (11)

• Northwick Park Neck Pain Questionnaire (NPQ)

  Baseline (Week 1), Week 4, 6, 9, 17, 29, 53

• Numeric rating scale (NRS) of neck and arm pain

  Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53

• Visual analogue scale (VAS) of neck and arm pain

  Baseline (Week 1), Week 2, 3, 4, 5, 6

• Neck Disability Index (NDI)

  Baseline (Week 1), Week 4, 6, 9, 17, 29, 53

• EuroQol-5 Dimension (EQ-5D)

  Baseline (Week 1), Week 4, 6, 9, 17, 29, 53

Study Arms (2)

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.

Procedure: Doin (conduction exercise); Device: Acupuncture

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).

Device: Acupuncture

Interventions

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.

Also known as: Doin Exercise, Do-in Exercise, Conduction Exercise

Doin with Acupuncture

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.

Acupuncture; Doin with Acupuncture

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Medical Foundation

Seoul, South Korea

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• In-Hyuk Ha, KMD, MPH

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 4, 2017
• Study Start: February 27, 2017
• Primary Completion: August 23, 2017
• Study Completion: August 22, 2018
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)