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Thread-embedding Combined With Auricular Acupuncture for Non-specific Chronic Low Back Pain

NCT06682273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-03-24

No results posted yet for this study

Summary

Low back pain (LBP) is a significant global health issue, with cases expected to rise by 36.4% by 2050. Chronic LBP (cLBP), lasting over three months, is mostly non-specific cLBP (cNLBP), posing a challenge for effective management. Common treatments include medication, exercise, and acupuncture.

This study explores the combined use of thread-embedding and auricular acupuncture for treating cNLBP, as combining these methods is thought to enhance effectiveness. Participants with cNLBP will be randomized into four groups to receive either the combination of both treatments, each treatment individually with a sham, or both shams. The study will last eight weeks, with four weeks of intervention and four weeks of follow-up. Treatment outcomes, including pain, disability, medication use, and quality of life, will be evaluated, along with monitoring for adverse effects.

Conditions

  • Chronic Non-Specific Low Back Pain

Interventions

OTHER

Thread-embedding acupuncture

Thread-embedding acupuncture is performed every week for 4 weeks, using a single Polydioxaone thread inserted into acupoints on the body through the needle. After the thread is inserted, the needle will be immediately withdrawn.

OTHER

Auricular acupuncture

Auricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into therapeutic points on the ear. The patches with the needle will remain in place for one week.

OTHER

Sham thread-embedding acupuncture

Sham thread-embedding acupuncture is performed every week for 4 weeks, using the needle without thread inserted into acupoints on the body. After insertion, the needle will be immediately withdrawn, and no thread will be left in the body.

OTHER

Sham auricular acupuncture

Sham auricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into non-therapeutic points on the ear. The patches with the needle will remain in place for one week.

Sponsors & Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2025-02-20
Completion
2025-03-20

Countries

  • Vietnam

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 NCT06682273 on ClinicalTrials.gov