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

The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain: a Pilot Multicenter Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Procedure: Doin (conduction exercise); Device: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Jaseng Medical Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Northwick Park Neck Pain Questionnaire (NPQ)	Change in pain and functional disability questionnaire	6 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Northwick Park Neck Pain Questionnaire (NPQ)	Pain and functional disability questionnaire	Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Numeric rating scale (NRS) of neck and arm pain	Pain scale	Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53
Visual analogue scale (VAS) of neck and arm pain	Pain scale	Baseline (Week 1), Week 2, 3, 4, 5, 6
Neck Disability Index (NDI)	Functional disability questionnaire	Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
EuroQol-5 Dimension (EQ-5D)	Health-related quality of life questionnaire	Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Patient Global Impression of Change (PGIC)	Global, patient-reported outcome	Week 4, 6, 9, 17, 29, 53
Short Form Health Survey 12 (SF-12)	Health-related quality of life questionnaire	Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Cost per QALY (quality-adjusted life year)	Economic evaluation	Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Cost per NRS	Economic evaluation	Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
Drug Consumption	Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments (e.g. physical therapy, injection therapy)	Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
Adverse events	Safety outcome	Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Actual): August 23, 2017
• Study Completion (Actual): August 22, 2018

Study Registration Dates

• First Submitted: December 28, 2016
• First Submitted That Met QC Criteria: December 30, 2016
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Acupuncture; Neck Pain; Disability Evaluation; Costs and Cost Analysis; Doin Exercise Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: JS-CT-2016-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No