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Efficiency Comparison Between Methylprednisolone and Phenol 8% Treatment Using a Trans Sacral Approach - on Lower Back Pain and Limbs

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01468415
First Posted: November 9, 2011
Last Update Posted: November 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center
  Purpose
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%.

Condition Intervention Phase
Back Pain Drug: phenol Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficiency Comparison Between Methylprednisolone and Phenol 8% Treatment Using a Trans Sacral Approach - on Lower Back Pain and Limbs

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: phenol
    1 cc of 8% phenol dissolved in water or 20cc of 8o mg Methylprednisolone diluted in 0.25% marcaine.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468415


Locations
Israel
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel
Contact: Murat Bahar, M.D    0577-345466      
Contact: Josef Veltzer, M.D    052-3420815      
Principal Investigator: Murat Bahar, M.D         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01468415     History of Changes
Other Study ID Numbers: 58/11
First Submitted: November 6, 2011
First Posted: November 9, 2011
Last Update Posted: November 9, 2011
Last Verified: May 2011

Keywords provided by Assaf-Harofeh Medical Center:
Methylprednisolone
trans sacral block
phenol

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Phenol
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants