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Effect of Thread-Embedding Acupuncture at EX-B2 on Pain and Quality of Life in Chronic Low Back Pain

NCT07337187 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-01-13

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether thread-embedding acupuncture (TEA) is more effective than sham thread-embedding acupuncture in treating adults with chronic low back pain. The study will also evaluate the safety of TEA.

The main questions it aims to answer are:

* Does TEA reduce pain intensity more effectively than sham TEA?
* Does TEA improve quality of life compared with sham TEA?
* Does TEA reduce the frequency of bothersome pain episodes?
* Does TEA reduce the use of routine and additional (extra) pain medications?
* What side effects occur in participants receiving TEA compared with sham TEA?

Researchers will compare TEA with sham TEA (a procedure that mimics acupuncture without needle insertion or thread placement) to determine whether TEA provides greater and longer-lasting benefits for chronic low back pain.

Participants will:

* Receive a single session of TEA or sham TEA
* Continue using pain medications as prescribed by their physician
* Be evaluated at weeks 2, 4, 6, and 8 after treatment
* Complete pain assessments, quality-of-life questionnaires, and reports of pain episodes and medication use
* Attend in-person clinic visits at weeks 4 and 8, and receive telephone follow-ups at weeks 2 and 6

Conditions

  • Low Back Pain

Interventions

DEVICE

Thread-embedding acupuncture

Thread-embedding acupuncture is performed bilaterally at a pair of lumbar EX-B2 points using needles containing polydioxanone (PDO) threads, positioned 12.5 mm lateral to the spinous processes. The targeted EX-B2 level is selected from L1 to L5 based on the subject's main pain location, informed by dermatome and myotome mapping and lumbar segmental concepts.

DEVICE

Sham Thread-embedding acupuncture

Sham thread-embedding acupuncture is performed bilaterally at the lumbar EX-B2 points using needles that are placed in contact with the skin at the acupuncture point sites without skin penetration. The targeted EX-B2 level is selected from L1 to L5 based on the subject's predominant pain location, guided by dermatome and myotome mapping and the principles of lumbar segmental innervation.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • KEPK FKUI-RSCM · The Health Research Ethics Commitee of Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07337187 on ClinicalTrials.gov