- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06868173
Trigger Point Electroacupuncture Treatment in Patients With Chronic Low Back Pain
August 22, 2025 updated by: Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City
Evaluation of the Analgesic Efficacy of Trigger Point Electroacupuncture in Patients With Chronic Low Back Pain: a Blinded Randomised Controlled Trial
Electroacupuncture is an application of acupuncture combined with electrical stimulation of acupuncture points through acupuncture needles to achieve faster pain relief than acupuncture.
Recently, research has shown that Trigger point acupuncture has a significant effect in reducing pain better than acupuncture on acupoints in patients with chronic low back pain.
However, no research has compared the pain relief effect between Trigger Point electroacupuncture and electroacupuncture on acupoints in patients with chronic low back pain.
This study was conducted to address this question.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants and Methods: A blinded randomized controlled clinical trial was conducted involving 60 chronic low back pain participants, randomly divided into two groups (A and B): 30 receiving electroacupuncture at the Trigger point (group A) and 30 receiving electroacupuncture on the meridian (group B) for 10 sessions.
The primary outcomes were visual analogue scale (VAS), BPI index, and Trigger point count.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ho Chi Minh City, Vietnam
- University of Medical Center HCMC - Branch no.3, Ho Chi Minh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients aged 20 or older who consented to participate in the study;
- Individuals experiencing LBP persisting for more than 3 months with an average VAS score of 5 cm or over;
- Patients displaying trigger points in back
Exclusion Criteria:
- Major trauma or systemic disease such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Scheuermann disease;
- Systemic symptoms such as weight loss, fever of unknown origin, anorexia, personal history of malignancy, diffuse pain and joint stiffness;
- Symptoms of infection such as fever, meningeal irritation signs, photophobia;
- Symptoms of central motor neuron damage such as Hoffmann sign, Babinski sign, hyperreflexia, spasticity, incontinence, sexual dysfunction;
- Symptoms of serious acute diseases such as myocardial infarction (chest pain, sweating, shortness of breath), arterial dissections (tearing sensation, headache, blurred vision);
- Conditions unsuitable for acupuncture such as inflammation of skin in need of acupuncture, weak or exhausted patients, severe comorbidities;
- Being treated with other methods. Elimination criteria: Patients experiencing adverse events from the intervention leading to their discomfort and withdrawal from the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Electro-acupuncture at traditional points
30 patients with non-radiating low back pain for at least three months and normal neurological examination received treatment electro-cupuncture at traditional points for 10 sessions over 4 weeks, electroacupuncture was administered once per session, three sessions per week, on alternate days, with rest on Saturdays and Sundays.
Visual analogue scale (VAS) will be recorded after 1 session, 3 session, 5 session, 7 session and 10 session.
BPI index and Trigger point count will be recorded after 1 session, 5 session, 10 session.
|
Electroacupuncture at Trigger Points is electroacupuncture at predetermined trigger points.
Electroacupuncture at traditional acupoints is electroacupuncture at the following points: Jiaji (L2-L5), Yaoyangguan (GV3), Shendu (BL23), Dachangdu (BL25), and Weizhong (BL40).
|
|
Active Comparator: Electro-acupuncture at the Trigger point
30 patients with non-radiating low back pain for at least three months and normal neurological examination received treatment electro-acupuncture at the Trigger point for 10 sessions over 4 weeks, electroacupuncture was administered once per session, three sessions per week, on alternate days, with rest on Saturdays and Sundays.
Visual analogue scale (VAS) will be recorded after 1 session, 3 session, 5 session, 7 session and 10 session.
BPI index and Trigger point count will be recorded after 1 session, 5 session, 10 session.
|
Electroacupuncture at Trigger Points is electroacupuncture at predetermined trigger points.
Electroacupuncture at traditional acupoints is electroacupuncture at the following points: Jiaji (L2-L5), Yaoyangguan (GV3), Shendu (BL23), Dachangdu (BL25), and Weizhong (BL40).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of VAS pain intensity between electroacupuncture at the trigger point and electroacupuncture traditional point group
Time Frame: Baseline, after 3 sessions, after 5 sessions, after 7 sessions, after 10 sessions
|
With the VAS, participants were asked to make a hatch mark on a 100 mm line that represents their average pain intensity.
These were then converted to a numerical score for each face (i.e.
0, 2, 4, 6, 8, or 10), depending on the face selected.
The end-point descriptors for VAS was "No pain" (0, 0 mm, and the face representing no pain, respectively) and "The most intense pain imaginable" (10, 100 mm, and the face representing the most intense pain level, respectively).
|
Baseline, after 3 sessions, after 5 sessions, after 7 sessions, after 10 sessions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of BPI index between electroacupuncture at the trigger point and electroacupuncture traditional point group.
Time Frame: Baseline, after 5 sessions, and after 10 sessions
|
The BPI gives two main scores: a pain severity score and a pain interference score.
The pain severity score is calculated from the four items about pain intensity.
Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40.
The pain interference score corresponds to the item on pain interference.
The seven sub-items (general activity, mood, walking ability, normal walk, relations with other people, sleep, and enjoyment of life) are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.
The first item, pain drawing diagrams (painful and most painful areas) and the items on pain relief treatment or medication (list of the treatments and amount of relief) do not contribute to the scoring.
It takes approximately 5 minutes to complete the BPI.
|
Baseline, after 5 sessions, and after 10 sessions
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of trigger point count between electroacupuncture at the trigger point and electroacupuncture traditional point group
Time Frame: Baseline, after 5 sessions, and after 10 sessions
|
Determine the number of trigger points at each survey time.
|
Baseline, after 5 sessions, and after 10 sessions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Itoh K, Katsumi Y, Hirota S, Kitakoji H. Effects of trigger point acupuncture on chronic low back pain in elderly patients--a sham-controlled randomised trial. Acupunct Med. 2006 Mar;24(1):5-12. doi: 10.1136/aim.24.1.5.
- Schliessbach J, van der Klift E, Arendt-Nielsen L, Curatolo M, Streitberger K. The effect of brief electrical and manual acupuncture stimulation on mechanical experimental pain. Pain Med. 2011 Feb;12(2):268-75. doi: 10.1111/j.1526-4637.2010.01051.x. Epub 2011 Jan 28.
- Leite PMS, Mendonca ARC, Maciel LYS, Poderoso-Neto ML, Araujo CCA, Gois HCJ, Souza JHS, DeSantana JM. Does Electroacupuncture Treatment Reduce Pain and Change Quantitative Sensory Testing Responses in Patients with Chronic Nonspecific Low Back Pain? A Randomized Controlled Clinical Trial. Evid Based Complement Alternat Med. 2018 Oct 8;2018:8586746. doi: 10.1155/2018/8586746. eCollection 2018.
- Itoh K, Katsumi Y, Kitakoji H. Trigger point acupuncture treatment of chronic low back pain in elderly patients--a blinded RCT. Acupunct Med. 2004 Dec;22(4):170-7. doi: 10.1136/aim.22.4.170.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2025
Primary Completion (Actual)
June 30, 2025
Study Completion (Actual)
July 15, 2025
Study Registration Dates
First Submitted
March 2, 2025
First Submitted That Met QC Criteria
March 5, 2025
First Posted (Actual)
March 10, 2025
Study Record Updates
Last Update Posted (Estimated)
August 29, 2025
Last Update Submitted That Met QC Criteria
August 22, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2588/DHYD-HDDD
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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