Chronic Low Back Pain (CLBP)NCT06868173

Trigger Point Electroacupuncture Treatment in Patients With Chronic Low Back Pain

A study testing Electro-acupuncture in people with Chronic Low Back Pain (CLBP) and Trigger Points, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: Chronic Low Back Pain (CLBP), Trigger Points
What is being tested?: Electro-acupuncture
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteVietnam
Study dates: 15 Mar 2025to 15 Jul 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

University of Medical Center HCMC - Branch no.3, Ho Chi Minh
Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: 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.

Read the 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.

Conditions: Chronic Low Back Pain (CLBP), Trigger Points
Being tested: Electro-acupuncture
Keywords: Electro-acupuncture, Trigger points, Low back pain
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electro-acupunctureDevice
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).

Study groups in NCT06868173
Study group	Role	What they receive
Electro-acupuncture at traditional points	Sham comparator	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. Receives: Device: Electro-acupuncture
Electro-acupuncture at the Trigger point	Active comparator	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. Receives: Device: Electro-acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of VAS pain intensity between electroacupuncture at the trigger point and electroacupuncture traditional point group
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).
Measured: Baseline, after 3 sessions, after 5 sessions, after 7 sessions, after 10 sessions

Secondary outcomes (1)

Comparison of BPI index between electroacupuncture at the trigger point and electroacupuncture traditional point group.
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.
Measured: Baseline, after 5 sessions, and after 10 sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202515 Jul 2025

First posted10 Mar 2025
Study start15 Mar 2025
Primary completion30 Jun 2025
Study completion15 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A blinded randomized controlled trial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06868173
Sponsor's protocol ID: 2588/DHYD-HDDD
Status last verified: Aug 2025
First submitted: 2 Mar 2025
Last updated: 29 Aug 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 30402136
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.
PubMed 21276188
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.
PubMed 15628774
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.
PubMed 16618043

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Analgesic Efficacy of Trigger Point Electroacupuncture in Patients With Chronic Low Back Pain: a Blinded Randomised Controlled Trial
ClinicalTrials.gov ID: NCT06868173
Acronym / sponsor ID: 2588/DHYD-HDDD
Conditions: Chronic Low Back Pain (CLBP), Trigger Points
Keywords: Electro-acupuncture, Trigger points, Low back pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
Study start: 15 Mar 2025 (actual)
Primary completion: 30 Jun 2025 (actual)
Study completion: 15 Jul 2025 (actual)
First posted: 10 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: A blinded randomized controlled trial

Arm	Type	Receives
Electro-acupuncture at traditional points	Sham comparator	Device: Electro-acupuncture30 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.
Electro-acupuncture at the Trigger point	Active comparator	Device: Electro-acupuncture30 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.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Electro-acupunctureElectroacupuncture 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).	Device	Electro-acupuncture at the Trigger point, Electro-acupuncture at traditional points

Primary outcome

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).

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
Results publication: PubMed 30402136Leite 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.
Results publication: PubMed 21276188Schliessbach 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.
Results publication: PubMed 15628774Itoh 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.
Results publication: PubMed 16618043Itoh 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Electro-acupuncture in people with Chronic Low Back Pain (CLBP) and Trigger Points, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06868173, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.