A randomised, prospective, double-blind controlled study evaluating the effectiveness of spinal endoscopy with adhesiolysis for the treatment of chronic low back pain
| ISRCTN | ISRCTN16558617 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16558617 |
| Secondary identifying numbers | 2 |
- Submission date
- 10/06/2005
- Registration date
- 15/06/2005
- Last edited
- 25/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Laxmaiah Manchikanti
Scientific
Scientific
2831 Lone Oak Road
Paducah, KY
42003
United States of America
| Phone | +1 270 554 8373 |
|---|---|
| drm@asipp.org |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 1. To demonstrate clinically significant improvements in the spinal endoscopy with adhesiolysis patients compared to those patients randomized to the control group who did not receive spinal endoscopy therapy, but received epidural injections. Improvement will be assessed in relation to the clinical outcome measures of pain and function. 2. To evaluate and compare the adverse event profile in both groups |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic low back pain and lower extremity pain |
| Intervention | Spinal endoscopy with adhesiolysis using Myeloscope® (Visionary Biomedical Inc) Epidural local anesthetic with steroid |
| Intervention type | Other |
| Primary outcome measure | 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 measures | To assess adverse events in both groups |
| Overall study start date | 23/01/2002 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Maximum 100 patients total - Study included total of 83 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 23/01/2002 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- United States of America
Study participating centre
2831 Lone Oak Road
Paducah, KY
42003
United States of America
42003
United States of America
Sponsor information
Institutional Review Board of Ambulatory Surgery Center (USA)
Hospital/treatment centre
Hospital/treatment centre
2831 Lone Oak Road
Paducah, Kentucky
42003
United States of America
| Phone | +1 270 554 8373 |
|---|---|
| painmgmt@apex.net | |
"ROR" |
https://ror.org/02swzn148 |
Funders
Funder type
Industry
The Myeloscope® Spinal Endoscopy Introducer and Video-Guided Catheter System used in this study were provided by Clarus Medical Systems, Inc. No other external support or funding were received in completion of this study.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/07/2005 | Yes | No |
