Efficacy and Safety of Acupuncture Combined With Chinese Herbal Fumigation for Chronic Non-Specific Neck Pain

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.

Conditions

• Chronic Non-specific Neck Pain

Interventions

OTHER

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).

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman

  lead OTHER

Principal Investigators

• Yang Mooi Lim, Prof. & Dr. · M. Kandiah Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Sungai Long Campus

• Chai Nien Foo, Phd · M. Kandiah Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Sungai Long Campus

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2027-02-28

Completion

2027-03-31

Countries

• Malaysia

Study Locations