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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03009071
Recruitment Status : Completed
First Posted : January 4, 2017
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
In-Hyuk Ha, KMD, Jaseng Medical Foundation

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.

Condition or disease Intervention/treatment Phase
Chronic Neck Pain Procedure: Doin (conduction exercise) Device: Acupuncture Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain: a Pilot Multicenter Randomized Controlled Clinical Trial
Actual Study Start Date : February 27, 2017
Actual Primary Completion Date : August 23, 2017
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Doin with Acupuncture
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)
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.
Other Names:
  • Doin Exercise
  • Do-in Exercise
  • Conduction Exercise

Device: 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.

Active Comparator: Acupuncture
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
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.




Primary Outcome Measures :
  1. Change in Northwick Park Neck Pain Questionnaire (NPQ) [ Time Frame: 6 weeks from baseline ]
    Change in pain and functional disability questionnaire


Secondary Outcome Measures :
  1. Northwick Park Neck Pain Questionnaire (NPQ) [ Time Frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 ]
    Pain and functional disability questionnaire

  2. Numeric rating scale (NRS) of neck and arm pain [ Time Frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 ]
    Pain scale

  3. Visual analogue scale (VAS) of neck and arm pain [ Time Frame: Baseline (Week 1), Week 2, 3, 4, 5, 6 ]
    Pain scale

  4. Neck Disability Index (NDI) [ Time Frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 ]
    Functional disability questionnaire

  5. EuroQol-5 Dimension (EQ-5D) [ Time Frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 ]
    Health-related quality of life questionnaire

  6. Patient Global Impression of Change (PGIC) [ Time Frame: Week 4, 6, 9, 17, 29, 53 ]
    Global, patient-reported outcome

  7. Short Form Health Survey 12 (SF-12) [ Time Frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 ]
    Health-related quality of life questionnaire

  8. Cost per QALY (quality-adjusted life year) [ Time Frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 ]
    Economic evaluation

  9. Cost per NRS [ Time Frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53 ]
    Economic evaluation

  10. Drug Consumption [ Time Frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit) ]
    Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments (e.g. physical therapy, injection therapy)

  11. Adverse events [ Time Frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit) ]
    Safety outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009071


Locations
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Korea, Republic of
Jaseng Medical Foundation
Seoul, Korea, Republic of
Sponsors and Collaborators
Jaseng Medical Foundation
Investigators
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Principal Investigator: In-Hyuk Ha, KMD, MPH Jaseng Medical Foundation
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Responsible Party: In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation
ClinicalTrials.gov Identifier: NCT03009071    
Other Study ID Numbers: JS-CT-2016-18
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by In-Hyuk Ha, KMD, Jaseng Medical Foundation:
Neck Pain
Disability Evaluation
Costs and Cost Analysis
Doin Exercise Therapy
Acupuncture
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations