The Effectiveness of Chuna Maintenance Therapy for Chronic Bothersome Neck Pain

Not Applicable

Recruiting

• Conditions: Neck Pain; Chronic Pain
• Interventions: Procedure: Chuna Maintenance Therapy

• Registration Number: NCT06591221
• Lead Sponsor: Jaseng Medical Foundation

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-07-07
• Study First Submitted: 2024-08-31
• Study First Submitted QC: 2024-09-07
• Last Update Submitted: 2024-09-07
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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

Exclusion Criteria

1. Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. spinal metastasis of tumor(s), acute fracture, spinal dislocation)
2. Patients with progressive neurologic deficit or severe neurologic symptoms such as spinal cord injury
3. Patients whose pain is due to soft tissue disease not the spine (e.g. tumors, fibromyalgia, rheumatoid arthritis, gout)
4. 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)
5. Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
6. Pregnant patients or patients with plans of pregnancy or lactating patients
7. Patients within 3 months after cervical surgery
8. 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
9. Patients having difficult to completing the written informed consent
10. Patients who are deemed unsuitable by the researchers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chuna maintenance therapy group	Chuna Maintenance Therapy	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)
Lifestyle management & self-exercise group	Chuna Maintenance Therapy	This group will perform lifestyle management and daily self-exercise. The exercise education will be performed per 4 weeks for total 20 weeks.

Primary Outcome Measures

Name	Time	Method
NRS (Numeric rating scale)	Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25	Ranging 0-10 likert scale (higher=worse)
NDI (Neck disability index)	Wk 1, 5, 9, 13, 17, 21, 25	Each of the 10 items scores from 0 to 5, The maximum score is 50 (higher=worse)

Secondary Outcome Measures

Name	Time	Method
VAS(Visual analogue scale) for pain	Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25	Ranging 0-10cm scale (higher=worse)
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	PGIC is a 7 point scale depicting a patient's rating of overall improvement (higher=worse)
EQ-5D-5L( The 5-level EuroQol-5)	Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25	5 items for self-rating of overall health (lower=worse)
HINT-8 (health-related quality of life instrument-8)	Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25	8 items for self-rating of overall health (lower=worse)
Rating for Credibility and Expectancy of the treatment	Once at screening procedure	Ranging 1-9 likert scale (higher=more credible, positive results are expected)
Drug consumption history	Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25	Whether medication was used (Y/N)

Trial Locations

Locations (7)

Bucheon Jaseng Hospital of Korean Medicine; 🇰🇷 Bucheon, Korea, Republic of

Daejeon Jaseng Hospital of Korean Medicine; 🇰🇷 Daejeon, Korea, Republic of

Haeundae Jaseng Hospital of Korean Medicine; 🇰🇷 Haeundae, Korea, Republic of

College of Korean Medicine, Kyung Hee University; 🇰🇷 Seoul, Korea, Republic of

Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Kyung Hee University; 🇰🇷 Seoul, Korea, Republic of

Jaseng Hospital of Korean Medicine; 🇰🇷 Seoul, Korea, Republic of

School of Korean Medicine, Pusan National University; 🇰🇷 Yangsan, Korea, Republic of