Study to Evaluate Ferris PainWrap in the Treatment of Chronic Low Back

Status Completed

Clinical Trial Summary

The purpose of this study is to see if the Ferris PainWrap is effective in the treatment of chronic low back pain.

Clinical Trial Description

This is a phase 4 study to determine if a semipermeable hydrophilic membrane marketed as Ferris PainWrap can relieve low back pain more effectively than a placebo wrap. In the United States, the prevalence of low back pain of at least 1 month's duration is about 15% and its incidence is 5%. It is one of the two most common pain complaints. Low back pain is thus a major health problem in this country and worldwide. Treatment that relieves low back pain and restores function would be of great benefit to the individual and the community at large, particularly if the treatment is convenient and has no significant adverse effects. Ferris PainWrap was originally developed as a burn dressing and is commercially available for this purpose. The Food and Drug Administration approved the material as Ferris Hydrophilic Dressing for marketing in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. The material is classified as a medical device. It was found to relieve pain, inflammation, swelling, and bruising over traumatized areas. Subsequently, it appeared to relieve low back pain in informal, open (non-blinded) trials. The proposed mechanism for low back pain relief is by alteration of cutaneous A-beta receptor and possibly cutaneous A-delta fiber function through shifts in sodium and water concentrations in the skin. This study will compare a "no dose" placebo to a "high-dose" back wrap. It is a one year pilot study which will be randomized, double-blinded, and controlled, comparing Ferris PainWrap to an identical appearing placebo back wrap in individuals with chronic low back pain of three months duration or longer. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00364065
Study type	Interventional
Source	Pain and Rehabilitation Medicine
Contact
Status	Completed
Phase	Phase 4
Start date	September 2006
Completion date	April 2007

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study to Evaluate Ferris PainWrap in the Treatment of Chronic Low Back Pain

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms