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 because the information has not been verified recently.
Verified May 2011 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
First received: November 6, 2011
Last updated: November 8, 2011
Last verified: May 2011
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01468415

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 
Study First Received: November 6, 2011
Last Updated: November 8, 2011
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 23, 2016