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Clinical Trials/KCT0002848
KCT0002848
Completed
未知

Clinical research on the efficacy and safety of Bosinji on low back pain and radiculopathy by herniated intervertebral disc of lumbar spine; A multicenter, randomized, controlled, clinical trial

Kyung Hee University0 sites74 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Diseases of the musculo-skeletal system and connective tissue
Sponsor
Kyung Hee University
Enrollment
74
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional Study
Sex
All

Investigators

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 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\. 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)

Outcomes

Primary Outcomes

Not specified

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