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

NCT03558178 | Completed

• 1 other identifier: JS-CT-2018-03
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Chronic Neck Pain

Outcome Measures

Primary Outcomes (1)

• Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline

  VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.

  Week 5 post-baseline (screening)

Secondary Outcomes (19)

• Difference between visual analogue scale (VAS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively

  Week 1, 2, 3, 4, 5, 6 post-baseline (screening)

• Difference between numeric rating scale (NRS) of neck pain for the past 3 days at each timepoint and baseline, respectively

  Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)

• Difference between numeric rating scale (NRS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively

  Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)

• Difference between Neck Disability Index (NDI) at each timepoint and baseline, respectively

  Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)

• Difference between Northwick Park Neck Pain Questionnaire (NPQ) at each timepoint and baseline, respectively

  Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)

Study Arms (2)

Doin with Acupuncture

EXPERIMENTAL

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.

Procedure: Doin with acupuncture; Device: Acupuncture

Acupuncture

ACTIVE COMPARATOR

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).

Device: Acupuncture

Interventions

Doin with acupuncture 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).

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

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 (total 10 sessions).

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead
• Kyung Hee University Hospital at Gangdong: collaborator

Study Sites (5)

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi-do, South Korea

Location

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

Location

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, South Korea

Location

Jaseng Hospital of Korean Medicine

Seoul, 06110, South Korea

Location

Kyung Hee University Oriental Medicine Hospital at Gangdong

Seoul, South Korea

Location

Related Publications (2)

• Lee SM, Kim SJ, Nam D, Park YC, Kim EJ, Ha IH, Lee YJ. Comparison of preference-based health-related quality of life measures for chronic neck pain: a pooled analysis of data from three RCTs. BMJ Open. 2024 Dec 26;14(12):e086104. doi: 10.1136/bmjopen-2024-086104.

  PMID: 39725423 DERIVED

• Lee SH, Lee J, Lee YJ, Kim MR, Cho JH, Kim KW, Ha IH. Effectiveness and cost-effectiveness of acupuncture with Doin therapy for chronic neck pain: a study protocol for a multicentre, randomised controlled clinical trial. BMJ Open. 2019 May 10;9(5):e026632. doi: 10.1136/bmjopen-2018-026632.

  PMID: 31079083 DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• In-Hyuk Ha, KMD, Ph.D

  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: June 1, 2018
• First Posted: June 15, 2018
• Study Start: July 6, 2018
• Primary Completion: January 8, 2019
• Study Completion: December 5, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)