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ISRCTN
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ISRCTN16558617
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ClinicalTrials.gov identifier
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Public title
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A randomised, prospective, double-blind controlled study evaluating the effectiveness of spinal endoscopy with adhesiolysis for the treatment of chronic low back pain
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Scientific title
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Acronym
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N/A
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Serial number at source
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2
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Chronic low back pain and lower extremity pain
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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23/01/2002
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Anticipated end date
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31/12/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Maximum 100 patients total - Study included total of 83 patients
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Interventions
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Spinal endoscopy with adhesiolysis using Myeloscope® (Visionary Biomedical Inc)
Epidural local anesthetic with steroid
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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To assess adverse events in both groups
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Sources of funding
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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.
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16000173
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Contact name
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Dr
Laxmaiah
Manchikanti
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Address
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2831 Lone Oak Road
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City/town
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Paducah, KY
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Zip/Postcode
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42003
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Country
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United States of America
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Tel
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+1 270 554 8373
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Fax
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+1 270 554 8987
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Email
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drm@asipp.org
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Sponsor
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Institutional Review Board of Ambulatory Surgery Center (USA)
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Address
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2831 Lone Oak Road
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City/town
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Paducah, Kentucky
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Zip/Postcode
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42003
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Country
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United States of America
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Tel
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+1 270 554 8373
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Fax
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+1 270 554 8987
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Email
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painmgmt@apex.net
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Date applied
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10/06/2005
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Last edited
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25/09/2009
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Date ISRCTN assigned
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15/06/2005
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