A randomised, prospective, double-blind controlled study evaluating the effectiveness of spinal endoscopy with adhesiolysis for the treatment of chronic low back pain

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2005
INTERVENTION: Spinal endoscopy with adhesiolysis using Myeloscope® (Visionary Biomedical Inc) Epidural local anesthetic with steroid CONDITION: Chronic low back pain and lower extremity pain ; Musculoskeletal Diseases PRIMARY OUTCOME: To demonstrate a clinically significant difference between the treated patients and those patients randomized to the control group in the Physical Function and Pain at 1, 3, 6 and 12 months post treatment SECONDARY OUTCOME: To assess adverse events in both groups INCLUSION CRITERIA: 1. Candidate is between 18 and 65 years of age 2. Subjects with a history of chronic, function limiting low back pain of at least six months in duration 3. Subjects who are able to give voluntary, written informed consent to participate in this investigation 4. Subjects who, in the opinion of the Investigator, are able to understand this investigation, co‐operate with the investigational procedures and are willing to return to the clinic for all the required post‐operative follow‐ups 5. The subject has not had recent surgical procedures within the last three months
Epistemonikos ID: 2c6030aba52c5c4ae33931a070fbfe2d27216e20
First added on: Aug 21, 2024