Efficiency Comparison Between Methylprednisolone and Phenol 8% Treatment Using a Trans Sacral Approach

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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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

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Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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phenol

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Assaf Harofeh Medical Center

Ẕerifin, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Murat Bahar, M.D

Role: primary

0577-345466

Josef Veltzer, M.D

Role: backup

052-3420815

Other Identifiers

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58/11

Identifier Type: -

Identifier Source: org_study_id

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