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

Phase 1

• Conditions: Back Pain

• Registration Number: NCT01468415
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

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%.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-05
• Study Start: 2011-06
• Study First Submitted: 2011-11-06
• Study First Submitted QC: 2011-11-08
• Last Update Submitted: 2011-11-08
• Study First Posted: 2011-11-09
• Last Update Posted: 2011-11-09
• Primary Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Assaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel