Clinical Research on the Efficacy and Safety of Thread-embedding Acupuncture for Treatment of Herniated Intervertebral Disc of Lumbar Spine; A Multicenter, Randomized, Patient-assessor Blinded, Controlled, Parallel Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 70
- Locations
- 4
- Primary Endpoint
- Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 8
Study Overview
Brief Summary
This clinical trial is designed to evaluate the efficacy and safety of thread-embedding acupuncture for treatment of lumbar herniated intervertebral disc (L-HIVD) by assessing pain, function, and quality of life.
Detailed Description
Seventy patient between the ages of 19 and 70 with L-HIVD will be recruited by eligibility criteria and randomly allocated to the thread-embedding acupuncture (TEA) group and sham thread-embedding acupuncture (STEA) group. Both groups will receive treatment on predefined 23 acupoints once a week for 8 weeks, and needle with thread removed will be used in STEA group instead of normal TEA. 100 mm visual analogue scale (VAS) for low back pain will be assessed as a primary outcome. Also, 100mm VAS for radiating pain, Oswestry disability index (ODI), Rolland Morris disability questionnaire (RMDQ), EQ-5D-5L and global perceived effect (GPE) will be measured as secondary outcomes. All the outcomes will be assessed at baseline, 4 weeks after screening, treatment end (8 weeks, primary end point) and follow-up sessions (12 and 16 weeks).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female adults aged 19-70
- •Radiating pain matched with severer abnormality than bulging shown by CT or MRI on lumbar spine
- •40 or higher low back pain on 100mm pain VAS
- •Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials
Exclusion Criteria
- •Congenital abnormalities or surgical history on lumbar regions
- •Red flag signs that may be suspected of cauda equina syndrome, such as bladder and bowel dysfunction or saddle anesthesia
- •Tumor, fracture or infection in lumbar regions
- •Injection treatment on lumbar regions within 1 week
- •Psychiatric disorder currently undergoing treatment such as depression or schizophrenia
- •Inappropriate condition for thread-embedding acupuncture due to skin disease or hemostatic disorder (PT INR > 2.0 or taking anticoagulant)
- •Other diseases that could affect or interfere with therapeutic outcomes, including severe gastrointestinal disease, cardiovascular disease, hypertension, diabetes, renal disease, liver disease or thyroid disorder
- •Contraindication of acetaminophen including intercurrent disease, hypersensitivity reaction or other medication
- •Pregnant women or other inappropriate condition for thread-embedding acupuncture
- •Heavy drinking (more than 3 cups per day) that could cause hepatotoxicity with acetaminophen
Arms & Interventions
Thread-Embedding Acupuncture (TEA)
The TEA group will be treated once a week for 8 weeks, using 29G x 40mm or 29G x 60mm TEA on predefined 23 acupoints selected by expert group according to STRICTA. All other treatment affecting the outcomes will be prohibited during the trial period. All therapeutic procedure will be performed by acupuncture specialists who have received training for the consensus of multicenter.
Intervention: Thread-embedding Acupuncture (TEA) (Procedure)
Sham Thread-Embedding Acupuncture (STEA)
The STEA group will be treated once a week for 8 weeks, using 29G x 40mm or 29G x 60mm sham TEA on predefined 23 acupoints selected by expert group according to STRICTA.
Intervention: Sham Thread-embedding Acupuncture (STEA) (Procedure)
Outcomes
Primary Outcomes
Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 8
Time Frame: Week 1 (Baseline), Week 4, Week 8 (Primary end point, Treatment end), Week 12, Week 16 (F/U)
Measurement instrument for subjective pain
Secondary Outcomes
- Global Perceived Effect (GPE)(Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U))
- Oswestry Disability Index (ODI)(Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U))
- EuroQol-5 dimensions-5 level (EQ-5D-5L)(Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U))
- 100mm Pain Visual Analogue Scale (VAS) for radiating pain(Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U))
- Roland-Morris Disability Questionnaire (RMDQ)(Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U))
Investigators
Byung-Kwan Seo
PhD., KMD
Kyunghee University Medical Center