NCT06868173

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

March 2, 2025

Last Update Submit

August 22, 2025

Conditions

Keywords

Electro-acupunctureTrigger pointsLow back pain

Outcome Measures

Primary Outcomes (1)

  • 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).

    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.

    Baseline, after 5 sessions, and after 10 sessions

Other Outcomes (1)

  • Comparison of trigger point count between electroacupuncture at the trigger point and electroacupuncture traditional point group

    Baseline, after 5 sessions, and after 10 sessions

Study Arms (2)

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.

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.

Device: Electro-acupuncture

Interventions

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).

Electro-acupuncture at the Trigger pointElectro-acupuncture at traditional points

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ho Chi Minh City, Vietnam

Location

Related Publications (4)

  • 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.

    PMID: 30402136BACKGROUND
  • 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.

    PMID: 21276188BACKGROUND
  • 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.

    PMID: 15628774BACKGROUND
  • 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.

    PMID: 16618043BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The study participants will not know which electroacupuncture group they are in. The acupuncturist and the data processor are 2 different people.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A blinded randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Philosophy

Study Record Dates

First Submitted

March 2, 2025

First Posted

March 10, 2025

Study Start

March 15, 2025

Primary Completion

June 30, 2025

Study Completion

July 15, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Locations