Lumbar Disc Herniation
Conditions
Keywords
Herniated Intervertebral Disc of Lumbar Spine, Low Back Pain, Radiculopathy, Bosinji, Herbal Medicine
Brief summary
This randomized controlled clinical trial is designed to evaluate the efficacy and safety of Bosinji on low back pain and radiating pain of lumbar herniated intervertebral disc (L-HIVD) by assessing pain, function, and quality of life.
Detailed description
Seventy-four patients between the ages of 19 and 70 with L-HIVD will be recruited by eligibility criteria and randomly allocated to the experimental group and the control group. In the experimental group, 2.5g of Bosinji granule (Tsumura & Co., Tokyo, Japan) will be orally administered three times a day at 30 minutes after the meal for 6 weeks. In the control group, Loxonine tab. (loxoprofen 60mg, Dong Wha Pharm Co., Ltd, Seoul, Korea) will be orally administered in the same usage and period with the experimental group. In addition, both group will receive the same acupuncture treatment on 20 acupoints once a week for 6 weeks. 100 mm visual analogue scale (VAS) for low back pain will be assessed as a primary outcome at baseline and treatment end. Also, 100mm VAS for radiating pain, Oswestry disability index (ODI), Rolland Morris disability questionnaire (RMDQ), EQ-5D-5L and global perceived effect (GPE), Deficiency Syndrome of Kidney Index (DSKI) will be measured as secondary outcomes at baseline, 3 weeks after screening, treatment end (6 weeks, primary endpoint) and follow-up sessions (10 weeks).
Interventions
DRUGBosinji
Product name : Bosinji Granule Manufacturer : Tsumura & Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g) Bosinji extract is composed of following proportion of ingredient * Rehmannia Root 1.7g * Achyranthes Root 1.0g * Cornus Fruit 1.0g * Dioscorea Rhizome 1.0g * Psyllium Husk 1.0g * Alisma Rhizome 1.0g * Hoelen 1.0g * Moutan Root Bark 1.0g * Cinnamon Bark 0.3g * Pulvis Aconiti Tuberis Purificatum 0.3g
DRUGLoxonine tab.
Product name : Loxonine tab. Manufacturer : Dong Wha Pharm. Co., Ltd Ingredient : Loxoprofen Sodium 68.1mg (Loxoprofen 60mg)
PROCEDUREAcupuncture
Acupuncture treatment will be performed on 20 predefined acupoint using 0.25mm x 40mm acupuncture needle. The time for needle retaining is 15 minutes. 1. Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints) 2. Both side BL24, BL25, BL26, EX-B7, BL28 (10 acupoints) 3. Symptomatic side GB30, GB34, BL57, ST36 (4 acupoints)
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
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men or women aged over 19 years 2. Radiating pain matched with severer abnormality than bulging shown by CT or MRI on lumbar spine 3. low back pain between 40 and 80 point on 100mm pain visual analogue scale 4. Volunteers who agree to participate and sign the Informed Consent Form, following a detailedexplanation 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. Liver function abnormality (AST or ALT over 2times normal range) 7. Renal fuction abnormaility (Serum creatinine \> 2.0㎎/㎗) 8. 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 9. Contraindication of NSAIDs including intercurrent disease, hypersensitivity reaction or other medication 10. Inappropriate condition for acupuncture due to skin disease or hemostatic disorder (PT INR \> 2.0 or taking anticoagulant) 11. Women who is pregnant, breastfeeding or having pregnancy plan 12. Other inappropriate condition for herbal medicine treatment 13. participation in other clinical trial with 1 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 6 | Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) | Measurement instrument for subjective pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) | Validated questionnaire for disability of low back pain |
| EuroQol-5 dimensions-5 level (EQ-5D-5L) | Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) | Standardized instrument for generic health status |
| 100mm Pain Visual Analogue Scale (VAS) for radiating pain | Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) | Measurement instrument for subjective pain |
| Global Perceived Effect (GPE) | Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) | Assessment of change in the patient's chief complaint |
| Deficiency Syndrome of Kidney Index (DSKI) | Week 0 (Baseline), Week 6 (Primary end point, Treatment end) | Questionnaire for assessing symptoms related to deficiency syndrome of kidney |
| Roland-Morris Disability Questionnaire (RMDQ) | Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U) | Health status measure for low back pain |
Countries
South Korea
Outcome results
None listed