Lumbar Disc Herniation
Conditions
Keywords
Thread-Embedding Acupuncture, Herniated Intervertebral Disc of Lumbar Spine, Low Back Pain, Radiculopathy
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).
Interventions
PROCEDUREThread-embedding Acupuncture (TEA)
The acupoints and size of TEA are as follows: 1. Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints): perpendicular insertion, 4cm 2. Both BL24: transverse insertion toward L1 level along the erector muscle of spine, 6cm 3. Both BL25: transverse insertion toward iliac crest, 4cm 4. Both BL26: transverse insertion toward L1 level along the erector muscle of spine, 6cm 5. Both BL26: oblique insertion toward iliolumbar ligament, 6cm 6. Both EX-B7: oblique insertion toward gluteus medius muscle, 6cm 7. Both BL28: oblique insertion toward sacroiliac ligament, 6cm 8. Both GB30: perpendicular insertion, 6cm 9. Symptomatic side GB34, BL57 and ST36: oblique insertion toward foot, 4cm
PROCEDURESham Thread-embedding Acupuncture (STEA)
All procedure of STEA group, including acupoints and size of TEA will be same as that of TEA group. However, thread-removed TEA will be used for STEA group instead of normal TEA, and removing procedure of thread will be performed aseptic and secretly for patient-blinding and prevention of infection.
Sponsors
Kyung Hee University Hospital at Gangdong
DongGuk University
Daegu Korean Medicine Hospital of Daegu Haany University
Kyunghee University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female adults aged 19-70 2. Radiating pain matched with severer abnormality than bulging shown by CT or MRI on lumbar spine 3. 40 or higher low back pain on 100mm pain VAS 4. Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials
Exclusion criteria
1. Congenital abnormalities or surgical history on lumbar regions 2. Red flag signs that may be suspected of cauda equina syndrome, such as bladder and bowel dysfunction or saddle anesthesia 3. Tumor, fracture or infection in lumbar regions 4. Injection treatment on lumbar regions within 1 week 5. Psychiatric disorder currently undergoing treatment such as depression or schizophrenia 6. Inappropriate condition for thread-embedding acupuncture due to skin disease or hemostatic disorder (PT INR \> 2.0 or taking anticoagulant) 7. 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 8. Contraindication of acetaminophen including intercurrent disease, hypersensitivity reaction or other medication 9. Pregnant women or other inappropriate condition for thread-embedding acupuncture 10. Heavy drinking (more than 3 cups per day) that could cause hepatotoxicity with acetaminophen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 8 | Week 1 (Baseline), Week 4, Week 8 (Primary end point, Treatment end), Week 12, Week 16 (F/U) | Measurement instrument for subjective pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 100mm Pain Visual Analogue Scale (VAS) for radiating pain | Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U) | Measurement instrument for subjective pain |
| Oswestry Disability Index (ODI) | Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U) | Validated questionnaire for disability of low back pain. |
| EuroQol-5 dimensions-5 level (EQ-5D-5L) | Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U) | Standardized instrument for generic health status |
| Roland-Morris Disability Questionnaire (RMDQ) | Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U) | Health status measure for low back pain |
| Global Perceived Effect (GPE) | Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U) | Assessment of change in the patient's chief complaint |
Countries
South Korea
Outcome results
None listed