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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:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01468415
First received: November 6, 2011
Last updated: November 8, 2011
Last verified: May 2011
  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
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Israel
Assaf Harofeh Medical Center
Zerifin, Israel
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:
Methylprednisolone
trans sacral block
phenol

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Phenol
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Sclerosing Solutions
Pharmaceutical Solutions
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

ClinicalTrials.gov processed this record on December 07, 2016