Clinical trial NCT03386149: Clinical Research on the Efficacy of Bosinji on Herniated Intervertebral Disc of Lumbar Spine
Official title: Clinical Research on the Efficacy and Safety of Bosinji on LBP and Radiculopathy by HIVD of L-spine; A Multicenter, Randomized, Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lumbar Disc Herniation
Keywords: Herniated Intervertebral Disc of Lumbar Spine
Low Back Pain
Radiculopathy
Bosinji
Herbal Medicine
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Kyung Hee University Hospital at Gangdong
name: DongGuk University
name: Daegu Korean Medicine Hospital of Daegu Haany University
First posted: 2017-12-29
Enrollment: 74
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 6
timeFrame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
Secondary outcomes:
measure: 100mm Pain Visual Analogue Scale (VAS) for radiating pain
timeFrame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
measure: Oswestry Disability Index (ODI)
timeFrame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
measure: EuroQol-5 dimensions-5 level (EQ-5D-5L)
timeFrame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
measure: Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: Week 0 (Baseline), Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
measure: Global Perceived Effect (GPE)
timeFrame: Week 3, Week 6 (Primary end point, Treatment end), Week 10 (F/U)
measure: Deficiency Syndrome of Kidney Index (DSKI)
timeFrame: Week 0 (Baseline), Week 6 (Primary end point, Treatment end)
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Dongguk University Bundang Oriental Hospital
state: Gyeonggi
city: Daegu
country: Korea, Republic of
facility: Daegu Korean Medicine Hospital of Daegu Haany University
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Kyunghee University Medical Center
name: Byung-Kwan Seo, PhD., KMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goo B, Kim SJ, Kim EJ, Nam D, Lee HJ, Kim JS, Park YC, Baek YH, Nam SS, Seo BK. Clinical research on the efficacy and safety of Bosinji for low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine: A protocol for a multicenter, randomized, controlled equivalence trial. Medicine (Baltimore). 2018 Dec;97(50):e13684. doi: 10.1097/MD.0000000000013684.