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Efficacy and Safety of Acupuncture Combined With Chinese Herbal Fumigation in the Treatment of Chronic Non-Specific Neck Pain: A Multicenter Randomized Controlled Trial
Sponsor: Universiti Tunku Abdul Rahman
Summary
Chronic non-specific neck pain is a common musculoskeletal disorder that significantly affects quality of life and functional ability. Conventional treatments often provide limited relief and may be associated with adverse effects. Acupuncture and Chinese herbal fumigation are commonly used therapies in traditional Chinese medicine and have shown potential benefits in pain relief and functional recovery. This multicenter randomized controlled trial aims to evaluate the efficacy and safety of acupuncture combined with Chinese herbal fumigation in patients with chronic non-specific neck pain. A total of 120 participants will be randomly assigned to three groups: acupuncture combined with Chinese herbal fumigation, acupuncture combined with sham fumigation, and acupuncture alone. All participants will receive five treatment sessions within three weeks, followed by a four-week follow-up period. The primary outcome measure is pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcome measures include the Neck Disability Index (NDI), cervical range of motion, Pittsburgh Sleep Quality Index (PSQI), quality of life scale, and Central Sensitization Inventory (CSI). This study aims to provide high-quality clinical evidence regarding the effectiveness of acupuncture combined with Chinese herbal fumigation for chronic non-specific neck pain.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-05
Completion Date
2027-03
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Acupuncture
Single-use sterile acupuncture needles (0.30 × 40 mm, Huatuo brand) are inserted at bilateral cervical Jiaji points (EX-B2). Needles are retained for 20 minutes with manipulation to achieve deqi. Treatment is provided five times over three weeks (approximately twice per week).
Wenyang Tongluo Fumigation Formula
A proprietary Chinese herbal formula (30 g herbal powder decocted with 1000 mL water) used for local neck fumigation. Temperature is controlled at 35°C for 3 minutes, then 40°C for 30 minutes. Steam outlet positioned 30 cm from the neck. Treatment is provided five times over three weeks.
Sham Fumigation
Pure water (1000 mL) is heated to produce steam for local neck fumigation under identical temperature and duration conditions as the active fumigation. Treatment is provided five times over three weeks.
Locations (1)
M. Kandiah Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Sungai Long Campus
Kajang, Selangor, Malaysia