The Effectiveness of Chuna Maintenance Therapy for Chronic Bothersome Neck Pain

NCT06591221 | Recruiting DMC

• 1 other identifier: JS-CT-2024-02
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 7

Brief Summary

This study is a pragmatic randomized controlled study that assessed 250 subjects complaining of chronic bothersome neck pain with mild discomfort in a 1:1 ratio: chuna maintenance therapy group (125 subjects, 1 time/2 weeks, total 20 weeks) and lifestyle management \& self-exercise group (125 subjects, exercise method education 1 time/4 weeks, total 20 weeks).

Conditions

Neck Pain; Chronic Pain

Keywords

Chuna therapy; Manual therapy; Chronic neck pain

Outcome Measures

Primary Outcomes (2)

• NRS (Numeric rating scale)

  Ranging 0-10 likert scale (higher=worse)

  Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25

• NDI (Neck disability index)

  Each of the 10 items scores from 0 to 5, The maximum score is 50 (higher=worse)

  Wk 1, 5, 9, 13, 17, 21, 25

Secondary Outcomes (8)

• VAS(Visual analogue scale) for pain

  Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25

• Number of days with bothersome neck pain

  Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25

• Recurrence

  Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25

• PGIC (Patient Global Impression of Change)

  Wk 21, 25

• EQ-5D-5L( The 5-level EuroQol-5)

  Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25

Study Arms (2)

Chuna maintenance therapy group

EXPERIMENTAL

This group will receive chuna therapy determined by the clinician based on the subject's symptoms, degree of improvement, etc. (1 time/2 weeks, total 20 weeks)

Procedure: Chuna Maintenance Therapy

Lifestyle management & self-exercise group

OTHER

This group will perform lifestyle management and daily self-exercise. The exercise education will be performed per 4 weeks for total 20 weeks.

Procedure: Chuna Maintenance Therapy

Interventions

Chuna Maintenance Therapy PROCEDURE

it is conducted every two weeks for a total of 20 weeks for individuals. The technique follows the guidelines of the Society of Chuna Manual Medicine and is based on Chuna Medicine (2.5th edition), which is utilized as a textbook in Korean Medicine colleges. The treatment is selectively administered based on the clinical judgment of the practitioner.

Chuna maintenance therapy group; Lifestyle management & self-exercise group

Eligibility Criteria

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

You may qualify if:

• Aged 19 or older but under 70.
• Neck pain with pain duration of 12 months or longer
• NRS of neck pain over the past month is 2 or more but less than 4
• Patients who have agreed to trial participation and provided written informed consent

You may not qualify if:

• Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. spinal metastasis of tumor(s), acute fracture, spinal dislocation)
• Patients with progressive neurologic deficit or severe neurologic symptoms such as spinal cord injury
• Patients whose pain is due to soft tissue disease not the spine (e.g. tumors, fibromyalgia, rheumatoid arthritis, gout)
• Patients with other chronic disease(s) which may interfere with treatment effect, safety, or interpretation of outcome (e.g. stroke and myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy)
• Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
• Pregnant patients or patients with plans of pregnancy or lactating patients
• Patients within 3 months after cervical surgery
• Patients with experience of participating in another clinical study within 1 month or plan to participate in another clinical study during the study participation and follow-up period within 6 months from the participation date
• Patients having difficult to completing the written informed consent
• Patients who are deemed unsuitable by the researchers

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (7)

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, South Korea

RECRUITING

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, South Korea

RECRUITING

Haeundae Jaseng Hospital of Korean Medicine

Haeundae, South Korea

RECRUITING

College of Korean Medicine, Kyung Hee University

Seoul, South Korea

RECRUITING

Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Kyung Hee University

Seoul, South Korea

RECRUITING

Jaseng Hospital of Korean Medicine

Seoul, South Korea

RECRUITING

School of Korean Medicine, Pusan National University

Yangsan, South Korea

RECRUITING

Related Publications (1)

• Yun JM, Kim JY, Lee SH, Lee YJ, Heo I, Shin WC, Cho JH, Seo BK, Ha IH. Multi-Institutional Pragmatic Randomized Controlled Trial to Evaluate the Effectiveness of Manual Maintenance Therapy for Chronic Bothersome Neck Pain. J Pain Res. 2026 Mar 18;19:577619. doi: 10.2147/JPR.S577619. eCollection 2026.

  PMID: 41873381 DERIVED

MeSH Terms

Conditions

Neck Pain; Chronic Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ha

CONTACT

+82-2-2222-2740; hanihata@gmail.com

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: SPONSOR

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: September 19, 2024
• Study Start: July 7, 2024
• Primary Completion: February 3, 2026
• Study Completion: March 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

KR (7)