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Effectiveness of Thread-Embedding Acupuncture at EX-B2 on the Oswestry Disability Index and Finger-to-Floor Distance in Chronic Low Back Pain

NCT07395102 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-02-09

No results posted yet for this study

Summary

Chronic low back pain (CLBP) is a leading cause of disability worldwide and significantly impairs functional capacity and quality of life. Non-pharmacological therapies are recommended as first-line management, and acupuncture has demonstrated potential benefits in reducing pain and disability. Thread embedding acupuncture (TEA) is a modified acupuncture technique that provides prolonged stimulation through the implantation of absorbable polydioxanone (PDO) threads at acupuncture points.

This randomized controlled trial aims to evaluate the effectiveness of TEA at the EX-B2 points compared with sham TEA in improving disability and lumbar flexibility in patients with chronic non-specific low back pain. Disability will be assessed using the Oswestry Disability Index (ODI), and lumbar flexibility will be measured using the Finger-to-Floor Distance (FFD) test over an 8-week follow-up period.

Conditions

  • Chronic Low-back Pain

Interventions

DEVICE

Thread Embedding Acupuncture

Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The assigned procedures will be administered once, and outcomes will be evaluated over an 8-week follow-up period.

DEVICE

Sham Thread Embedding Acupuncture

Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The assigned procedures will be administered once, and outcomes will be evaluated over an 8-week follow-up period.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • KEPK FKUI-RSCM · Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital (HREC FMUI-CMH) (Komite Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Indonesia - RSUP Nasional Dr. Cipto Mangunkusumo)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-03-31
Completion
2026-05-31

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 NCT07395102 on ClinicalTrials.gov