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

NCT07515690 | Not Yet Recruiting

• 3 other identifiers: UTAR-TCM-CNP-RCT-2026-01UTAR-PhD-GJY-2025UTAR-REC-PENDING-2026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acupuncture; Chinese herbal fumigation; Chronic neck pain; Traditional Chinese medicine; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (T0), immediately after first treatment (T1), immediately after fifth treatment (T2), and at 4-week follow-up after final treatment (T3)

Secondary Outcomes (5)

• Neck Disability Index

  Baseline (T0), immediately after first treatment (T1), immediately after fifth treatment (T2), and at 4-week follow-up after final treatment (T3)

• Cervical Range of Motion

  Baseline (T0), after first treatment (T1), after fifth treatment (T2), and at 4-week follow-up (T3)

• SF-36 Quality of Life Scale

  Baseline (T0), after fifth treatment (T2), and at 4-week follow-up (T3)

• Pittsburgh Sleep Quality Index

  Baseline (T0), after fifth treatment (T2), and at 4-week follow-up (T3)

• Central Sensitization Inventory

  Baseline (T0) and at 4-week follow-up (T3)

Study Arms (3)

Acupuncture Combined with Chinese Herbal Fumigation

EXPERIMENTAL

Participants receive acupuncture at bilateral cervical Jiaji points (EX-B2) combined with Chinese herbal fumigation using the Wenyang Tongluo Fumigation Formula. Five sessions over three weeks.

Other: Acupuncture; Other: Wenyang Tongluo Fumigation Formula

Acupuncture Combined with Sham Fumigation

SHAM COMPARATOR

Participants receive acupuncture at bilateral cervical Jiaji points (EX-B2) combined with sham fumigation using pure water under identical temperature and duration conditions. Five sessions over three weeks.

Other: Acupuncture; Other: Sham Fumigation

Acupuncture Alone

ACTIVE COMPARATOR

Participants receive acupuncture at bilateral cervical Jiaji points (EX-B2) alone. Five sessions over three weeks.

Other: Acupuncture

Interventions

Wenyang Tongluo Fumigation Formula OTHER

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.

Acupuncture Combined with Chinese Herbal Fumigation

Acupuncture OTHER

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).

Acupuncture Alone; Acupuncture Combined with Chinese Herbal Fumigation; Acupuncture Combined with Sham Fumigation

Sham Fumigation OTHER

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.

Acupuncture Combined with Sham Fumigation

Eligibility Criteria

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

You may qualify if:

• 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
• Conformity to both Western diagnostic criteria and Traditional Chinese Medicine pattern differentiation for "cold coagulation type" neck pain
• Voluntarily participate and provide signed informed consent

You may not qualify if:

• 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
• Known allergy to acupuncture needles or herbal fumigation components
• Receipt of other neck pain-related treatments (e.g., physical therapy, medication, or acupuncture) within the past month
• Presence of open wounds or skin lesions in the treatment area

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead

Study Sites (1)

M. Kandiah Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Sungai Long Campus

Kajang, Selangor, 43000, Malaysia

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yang Mooi Lim, Prof. & Dr.

  M. Kandiah Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Sungai Long Campus

  STUDY CHAIR

• Chai Nien Foo, Phd

  M. Kandiah Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Sungai Long Campus

  STUDY DIRECTOR

Central Study Contacts

Jianying Gao, Phd

CONTACT

+601111327863; realjiaying@163.com

Yau Pin Yap, Phd

CONTACT

+60166268482; yapyp@utar.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts are blinded to group allocation. Participants and acupuncturists are not blinded due to the nature of the fumigation intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multicenter, randomized, parallel three-arm, assessor-blind controlled trial.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)