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

NCT01468415 | Unknown Phase 1 DMC

• 1 other identifier: 58/11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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%.

Conditions

Back Pain

Keywords

Methylprednisolone; trans sacral block; phenol

Interventions

phenol DRUG

1 cc of 8% phenol dissolved in water or 20cc of 8o mg Methylprednisolone diluted in 0.25% marcaine.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, Israel

RECRUITING

MeSH Terms

Conditions

Back Pain

Interventions

Phenol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2011
• First Posted: November 9, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Last Updated: November 9, 2011

Record last verified: 2011-05

Locations

IL (1)