Effectiveness of Thread-Embedding Acupuncture at EX-B2 on the Oswestry Disability Index and Finger-to-Floor Distance in Chronic Low Back Pain
CompletedNot applicableNCT07395102
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effectiveness of Thread-Embedding Acupuncture at EX-B2 on the Oswestry Disability Index and Finger-to-Floor Distance in Chronic Low Back Pain
- Conditions
- Interventions
- Device: Thread Embedding Acupuncture
- Device: Sham Thread Embedding Acupuncture
- Sponsor
- Universitas Indonesia
- Start date
- 2026-03-13
- Primary completion
- 2026-05-13
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Indonesia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Male or female participants aged ≥ 18 years * Participants experiencing low back pain for at least 3 months (\>12 weeks) * Highest low back pain intensity within the past 2 weeks with a score of ≥ 3 on a 0-10 Numeric Pain Rating Scale (NPRS) * Receiving pharmacological therapy with a stable analgesic regimen for at least 2 weeks prior to enrollment * Presence of physical functional disability as indicated by an Oswestry Disability Index (ODI) score \> 20% * Willing and able to participate in the study until completion and to provide written informed consent Exclusion Criteria: * History of hypersensitivity reactions to acupuncture or thread embedding acupuncture, or known allergy to stainless steel or polydioxanone (PDO) threads * History of keloid formation * Presence of scars (cicatrices) or skin disorders at the thread embedding acupuncture insertion sites in the lower back area * Specific spinal pathology including fracture, tumor, infection, or severe lumbar spinal stenosis requiring surgical intervention * Structural spinal abnormalities (scoliosis or kyphosis) detected on physical examination * History of spinal surgery or indication for spinal surgery due to severe neurological deficits * Presence of cardiac disease, hematological disorders, or uncontrolled diabetes mellitus * Regular use of systemic steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, anticoagulants, or topical analgesic medications * Receipt of other treatments for low back pain, including dry needling, neuromuscular taping, spinal injections, or acupuncture within the past 2 weeks, or thread embedding acupuncture within the past 6 months * Severe cognitive impairment, severe psychiatric or psychological disorders, or history of alcohol or substance abuse * Pregnant or breastfeeding women, or women planning pregnancy within the next 6 months * Body mass index (BMI) \< 18 kg/m²
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07395102