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

Efficacy and Safety of Acupuncture Combined With Chinese Herbal Fumigation in the Treatment of Chronic Non-Specific Neck Pain: A Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Non-specific Neck Pain
• Intervention / Treatment: Other: Acupuncture; Other: Wenyang Tongluo Fumigation Formula; Other: Sham Fumigation

Detailed Description

Background and Rationale Chronic non-specific neck pain is a prevalent musculoskeletal condition and a leading contributor to disability worldwide. It is characterized by persistent pain, stiffness, and functional limitation without a clear underlying structural pathology. Although conventional treatments such as non-steroidal anti-inflammatory drugs, physical therapy, and exercise are widely used, their effectiveness is often limited and may be associated with adverse effects. Traditional Chinese medicine offers alternative therapeutic strategies, including acupuncture and herbal fumigation. Acupuncture is believed to unblock meridians and regulate pain pathways, while Chinese herbal fumigation combines thermal stimulation with transdermal absorption of medicinal components to improve local circulation and reduce inflammation. Despite their complementary mechanisms, high-quality randomized controlled trials evaluating the combined effect of these two therapies for chronic non-specific neck pain remain scarce. This study aims to address this gap by rigorously assessing the efficacy and safety of acupuncture combined with a standardized herbal fumigation formula.

Study Design and Setting This study is a multicenter, randomized, parallel three-arm controlled clinical trial. It will be conducted at two traditional Chinese medicine outpatient centers in Malaysia. The study will enroll 120 eligible participants who will be randomly allocated in a 1:1:1 ratio to one of three groups: (1) acupuncture combined with Chinese herbal fumigation, (2) acupuncture combined with sham fumigation, and (3) acupuncture alone. An assessor-blind design will be employed to minimize bias, meaning that outcome assessors and data analysts will be unaware of group allocation.

Participants and Eligibility Participants will be recruited from outpatient clinics, bulletin boards, and online health platforms. Eligible individuals must be aged 18 to 65 years, have chronic non-specific neck pain lasting at least three months, present with a Visual Analog Scale score of 4 or higher, and demonstrate a reduction in cervical range of motion of 20% or more. Both Western diagnostic criteria and traditional Chinese medicine pattern differentiation for "cold coagulation type" neck pain must be met. Key exclusion criteria include confirmed organic pathology (e.g., disc herniation, infection, tumor), severe systemic diseases, pregnancy, lactation, receipt of other neck pain treatments within the past month, open wounds or skin lesions in the treatment area, and known allergies to acupuncture needles or herbal components.

Interventions The treatment period consists of five sessions delivered over three weeks, approximately twice per week. A follow-up assessment will be conducted four weeks after the final treatment.

Acupuncture Combined with Chinese Herbal Fumigation Group: Participants receive acupuncture at bilateral cervical Jiaji points (EX-B2) using single-use sterile needles (0.30 × 40 mm). Needles are retained for 20 minutes with manipulation to achieve deqi. Fumigation is performed using the Wenyang Tongluo Fumigation Formula, a proprietary herbal blend prepared as a powder (30 g) and decocted with 1000 mL of water. Participants lie supine while the neck area is exposed to steam from a fumigation bed. The steam outlet is positioned 30 cm from the neck, with temperature controlled: 35°C for 3 minutes, followed by 40°C for 30 minutes.

Acupuncture Combined with Sham Fumigation Group: The acupuncture protocol is identical to the combined therapy group. Fumigation is performed using 1000 mL of pure water without any herbal components, under the same temperature and duration conditions. This design isolates the thermal and environmental effects of fumigation.

Acupuncture Alone Group: Participants receive acupuncture at bilateral cervical Jiaji points using the same protocol as the other groups. No fumigation is administered.

Outcome Measures Outcomes are assessed at four time points: baseline (T0), immediately after the first treatment (T1), immediately after the fifth treatment (T2), and at the four-week follow-up (T3).

Primary Outcome: Pain intensity is measured using the Visual Analog Scale, a 10 cm horizontal line where participants mark their pain level, with scores ranging from 0 (no pain) to 10 (worst possible pain).

Secondary Outcomes:

Neck Disability Index: A 10-item questionnaire assessing the impact of neck pain on daily living and function. Scores range from 0 to 50, with higher scores indicating greater disability.

Cervical Range of Motion: Measured using a digital goniometer to assess flexion, extension, lateral flexion, and rotation. Values are recorded in degrees.

SF-36 Quality of Life Scale: Assesses health status across eight domains, including physical functioning, bodily pain, and mental health. Scores are standardized from 0 to 100, with higher scores indicating better quality of life.

Pittsburgh Sleep Quality Index: Evaluates sleep quality over the past month. Total scores range from 0 to 21, with higher scores reflecting poorer sleep.

Central Sensitization Inventory: A 25-item questionnaire measuring symptoms associated with central sensitization. Scores range from 0 to 100, with higher scores indicating greater sensitization.

Safety Assessment: Adverse events will be continuously monitored throughout the treatment and follow-up periods. All events will be recorded, classified by severity, and managed according to the study protocol.

Randomization and Blinding A computer-generated random number sequence will be created by an independent statistician. Allocation will be concealed using sealed, opaque, sequentially numbered envelopes. Due to the nature of the fumigation intervention, participants and acupuncturists cannot be fully blinded. However, outcome assessors and data analysts will remain blinded to group allocation throughout the study to minimize detection bias.

Statistical Analysis Data analysis will follow the intention-to-treat principle, with missing data handled using the last observation carried forward method. The primary outcome (VAS) will be analyzed using a mixed-design analysis of variance with group (three levels) and time (four time points) as factors. Post-hoc comparisons will be adjusted using Bonferroni correction. Secondary outcomes will be analyzed using similar repeated measures models or nonparametric tests as appropriate. Categorical variables will be analyzed using chi-square tests. A two-tailed significance level of P < 0.01 will be considered statistically significant. Effect sizes will be reported as partial eta-squared. All analyses will be performed using SPSS version 26.0.

Ethical Considerations and Data Management This study will be conducted in accordance with the Declaration of Helsinki. Ethical approval has been submitted to the Universiti Tunku Abdul Rahman Research Ethics Committee. Written informed consent will be obtained from all participants prior to enrollment. Participants may withdraw at any time without consequence. All data will be collected using electronic case report forms and stored in password-protected, encrypted servers accessible only to authorized personnel. Personal identifiers will be removed to ensure confidentiality.

Study Status Participant recruitment is expected to begin in May 2026 and be completed by February 2027. Data collection and follow-up are expected to be finalized by May 2027.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianying Gao, Phd; Phone Number: +601111327863; Email: realjiaying@163.com
• Study Contact Backup: Name: Yau Pin Yap, Phd; Phone Number: +60166268482; Email: yapyp@utar.edu.my

Study Locations

• Malaysia
  • Selangor
    • Kajang, Selangor, Malaysia, 43000
      • M. Kandiah Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Sungai Long Campus
      • Contact: Jianying gao, Phd; Phone Number: 01111327863; Email: realjiaying@163.com
      • Contact: Yau Pin Yap, Phd; Phone Number: +60166268482; Email: yapya@utar.edu.my
      • Principal Investigator: Jianying Gao, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Any patient not meeting the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture Combined with Chinese Herbal Fumigation; 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; 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.
Sham Comparator: Acupuncture Combined with Sham Fumigation; 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; 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: 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.
Active Comparator: Acupuncture Alone; Participants receive acupuncture at bilateral cervical Jiaji points (EX-B2) alone. Five sessions over three weeks.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	Baseline (T0), after first treatment (T1), after fifth treatment (T2), and at 4-week follow-up (T3)
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.	Baseline (T0), after fifth treatment (T2), and at 4-week follow-up (T3)
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.	Baseline (T0), after fifth treatment (T2), and at 4-week follow-up (T3)
Central Sensitization Inventory	A 25-item questionnaire assessing symptoms associated with central sensitization. Each item is scored from 0 to 4, with total scores ranging from 0 to 100. Higher scores indicate greater central sensitization. A reduction of ≥10 points from baseline is considered clinically significant improvement.	Baseline (T0) and at 4-week follow-up (T3)

Collaborators and Investigators

• Sponsor: Universiti Tunku Abdul Rahman
• Investigators: Study Chair: Yang Mooi Lim, Prof. & Dr., M. Kandiah Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Sungai Long Campus; Study Director: Chai Nien Foo, Phd, M. Kandiah Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Sungai Long Campus

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Acupuncture; Randomized controlled trial; Traditional Chinese medicine; Chronic neck pain; Chinese herbal fumigation
• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: UTAR-TCM-CNP-RCT-2026-01; UTAR-PhD-GJY-2025 (Other Identifier: UTAR); UTAR-REC-PENDING-2026 (Other Identifier: UTAR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to confidentiality agreements and the study protocol's data management provisions. Data will be used solely for research purposes by authorized research personnel and will not be publicly available. Reasonable requests for data access may be submitted to the corresponding author after study completion, subject to institutional approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No