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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Disc Herniation
- Sponsor
- Kyunghee University Medical Center
- Enrollment
- 70
- Locations
- 4
- Primary Endpoint
- Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 8
- Status
- Completed
- Last Updated
- 6 years ago
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).
Investigators
Byung-Kwan Seo
PhD., KMD
Kyunghee University Medical Center
Eligibility Criteria
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
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))