Effect of Thread-Embedding Acupuncture at EX-B2 Acupoint on Pain Intensity and Quality of Life in Chronic Low Back Pain
CompletedNot applicableNCT07337187
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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)
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
Study details
- Official title
- The Effect of Thread-Embedding Acupuncture at EX-B2 Acupoint on Pain Intensity and Quality of Life in Patients With Chronic Low Back Pain
- Conditions
- Interventions
- Device: Thread-embedding acupuncture
- Device: Sham Thread-embedding acupuncture
- Sponsor
- Universitas Indonesia
- Start date
- 2026-02-09
- Primary completion
- 2026-04-29
- 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 * Subjects with low back pain lasting for at least 3 months (\>12 weeks) * Maximum low back pain intensity within the past 2 weeks of ≥3 on a 0-10 scale, measured using the Numeric Pain Rating Scale (NPRS) or the Face, Legs, Activity, Cry, Consolability (FLACC) scale * Willing to participate in the study until completion and able to provide written informed consent * Receiving pharmacological therapy with a stable analgesic regimen for at least the past 2 weeks, which may include non-opioid analgesics (paracetamol), opioid analgesics (codeine, tramadol, morphine), antidepressants (amitriptyline, duloxetine), anticonvulsants (gabapentin, pregabalin, carbamazepine), and/or muscle relaxants (eperisone, baclofen) Exclusion Criteria: * History of hypersensitivity to acupuncture or thread-embedding acupuncture (TEA), including allergy to stainless steel or polydioxanone threads * History of keloid formation or skin disorders at the planned TEA insertion sites in the low back area * Presence of specific spinal pathology, including fracture, tumor, infection, or severe lumbar spinal stenosis (Schizas grade C or D) requiring surgical intervention * Structural spinal abnormalities (scoliosis or kyphosis) detected on physical examination * History of spinal surgery or current indication for spinal surgery due to severe neurological deficits * Presence of other chronic pain syndromes (fibromyalgia, myofascial pain syndrome, neuropathic pain syndrome, arthritis, chronic pelvic pain, migraine, or chronic tension-type headache) or severe comorbidities (stroke with sensory deficits, Parkinson's disease, end-stage chronic kidney disease, or terminal heart failure) that may affect pain assessment * Presence of cardiac disease, hematologic disorders, or uncontrolled diabetes mellitus * Regular use of systemic steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, anticoagulants, or topical analgesics * Body mass index (BMI) \<18 kg/m² * Receive other therapies for low back pain, including dry needling, neuromuscular taping, or acupuncture within the past 2 weeks, or thread-embedding acupuncture within the past 6 months * Receive spinal interventional therapy (surgery or injection) within the past 3 months, or stem cell therapy for chronic low back pain within the past 12 months * Cognitive impairment or other neurological disorders, severe psychiatric or psychological conditions, or a his…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07337187