Chronic low back pain and lower extremity pain Musculoskeletal Diseases
Conditions
Interventions
Spinal endoscopy with adhesiolysis using Myeloscope® (Visionary Biomedical Inc)
Epidural local anesthetic with steroid
Sponsors
Institutional Review Board of Ambulatory Surgery Center (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Large contained or sequestered herniation. A small contained herniation is permitted (<4 mm). 2. Cauda Equina symptoms and/or compressive radiculopathy 3. Narcotic use of no greater than Hydrocodone 100 mg/day, Methadone of 60 mg or Morphine 100 mg, or dose equivalent 4. Uncontrolled major depression or uncontrolled psychiatric disorders 5. Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, history of gastrointestinal bleeding or ulcers, urinary sphincter dysfunction, progressive neurological deficit, infection, increased intracranial pressure, pseudotumor cerebri, intercranial tumors, unstable angina, and severe chronic obstructive pulmonary disease 6. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function 7. Women who are pregnant or lactating 8. Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment 9. Patients with multiple complaints involving hip osteoarthritis, will not be amenable to study due to the overlap of pain complaints 10. Inability to achieve appropriate positioning and inability to understand informed consent and protocol 11. History of adverse reaction to local anesthetic or anti-inflammatory drugs or history of gastrointestinal bleeding or ulcers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To assess adverse events in both groups | — |
Countries
United States of America
Outcome results
None listed