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.
Aged 18 to 65 years, any gender
Diagnosed with chronic non-specific neck pain lasting ≥ 3 months
Visual Analog Scale (VAS) pain score ≥ 4
Cervical range of motion reduced by ≥ 20% compared to normal range
Presence of confirmed cervical disc herniation, nerve compression, or other specific pathologies (e.g., infection, tumor, fracture, etc.)
History of cervical spine surgery or recent acute neck trauma
Concomitant severe systemic diseases (e.g., cardiovascular, hepatic, renal, hematological, or psychiatric disorders)
Pregnancy or breastfeeding
Parallel
Acupuncture
Other interventionSingle-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
Other interventionA 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
Other interventionPure 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.
Pain Intensity as Measured by the Visual Analog Scale
The Visual Analog Scale is a 10 cm horizontal line ranging from 0 (no pain) to 10 (worst possible pain). Participants mark their current pain level on the line, and the distance in centimeters from the "no pain" end to the mark is recorded as the pain score.
Neck Disability Index
A 10-item questionnaire assessing the impact of neck pain on daily living, work ability, and self-care. Each item is scored from 0 to 5, with total scores ranging from 0 to 50. Higher scores indicate greater disability.
Cervical Range of Motion
Measured using a digital goniometer to assess cervical flexion, extension, lateral flexion, and rotation. Values are recorded in degrees. An increase of ≥20% compared to baseline is considered clinically significant functional improvement.
SF-36 Quality of Life Scale
A 36-item questionnaire assessing health status across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better quality of life.
Pittsburgh Sleep Quality Index
A 19-item self-rated questionnaire assessing sleep quality over the past month, including sleep duration, sleep efficiency, and sleep disturbances. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. A reduction of ≥3 points from baseline is considered clinically significant improvement.
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