- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01468415
Efficiency Comparison Between Methylprednisolone and Phenol 8% Treatment Using a Trans Sacral Approach - on Lower Back Pain and Limbs
November 8, 2011 updated by: Assaf-Harofeh Medical Center
The American Society of Anesthesiologists Task Force on Management, Chronic Pain section, recommended Phenol neurolysis when other techniques have failed to provide adequate pain control.
In this study we sought to Compare the pain relieve on a Lower Back and Limbs obtained from Methylprednisolone and Phenol 8% Treatment given by Trans Sacral Approach.
The study includes patients who suffers from a chronic low back and/or limbs pain which were referred to be given epidural as a treatment.
Control group receives 80 mg Methylprednisolone while the test group receives phenol 8%.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zerifin, Israel
- Recruiting
- Assaf Harofeh Medical Center
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Contact:
- Murat Bahar, M.D
- Phone Number: 0577-345466
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Contact:
- Josef Veltzer, M.D
- Phone Number: 052-3420815
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Principal Investigator:
- Murat Bahar, M.D
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: -at least 18 years of age;
- chronic low back pain of at least 12 weeks duration;
- patients which were diagnosed as a candidate for epidural since other techniques have failed to provide adequate pain control
- Sciatica due to Lumbar Disc Herniation
- Neurogenic Claudication due to Lumbar Spinal Stenosis
Exclusion Criteria:
- patients with unbalanced high blood pressure
- patients who can not ley prone
- patients who consumes anti-clotting medications
- patients with bleeding problems
- patients with Diabetes
- patients who suffers from chronic non-specific lower back and limb pain
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Anticipated)
June 1, 2013
Study Registration Dates
First Submitted
November 6, 2011
First Submitted That Met QC Criteria
November 8, 2011
First Posted (Estimate)
November 9, 2011
Study Record Updates
Last Update Posted (Estimate)
November 9, 2011
Last Update Submitted That Met QC Criteria
November 8, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 58/11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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