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

Primary Purpose

Back Pain

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

phenol

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Methylprednisolone, trans sacral block, phenol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Assaf Harofeh Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01468415

First Posted

November 6, 2011

Last Updated

November 8, 2011

Sponsor

Assaf-Harofeh Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01468415

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Unknown status

Study Start Date

June 2011 (undefined)

Primary Completion Date

June 2013 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Back Pain

Keywords

Methylprednisolone, trans sacral block, phenol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

phenol

Intervention Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Assaf Harofeh Medical Center

City

Zerifin

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Murat Bahar, M.D

Phone

0577-345466

First Name & Middle Initial & Last Name & Degree

Josef Veltzer, M.D

Phone

052-3420815

First Name & Middle Initial & Last Name & Degree

Murat Bahar, M.D

12. IPD Sharing Statement

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

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