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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ferris PainWrap
Sponsored by
Pain and Rehabilitation Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: English speakers, necessary to understand the protocol and communicate observations to the investigators Low back pain of 3 months or longer. Acceptable conditions include non-specific low back pain or pain associated with lumbar spondylosis without neurological impairment associated with the stenosis. Numerical Pain Rating Scale value of 4.5 or higher, estimated for the past week where 0=no pain and 10=worst possible pain. Pain must interfere in some way with daily activities, assessed by Roland and Morris Disability Survey. Beck Depression Inventory score of 20 or less. Physical examination findings of tenderness, muscle spasm or taut bands, or myofascial trigger points in the low back region. The low back region is defined as the lumbosacral region, below the 12th thoracic vertebra down to the sacro-coccygeal junction, and extending laterally to the plane of the lumbar vertebral transverse processes. Exclusion Criteria: Pregnancy NPR rating score of less than 4.5. Neurologic impairment in the legs (absent knee or ankle deep tendon reflexes, dermatome sensory loss or weakness) that indicates lumbar radiculopathy. Presence of cancer (previous diagnosis of cancer, or treated cancer with no sign of recurrence for 5 years is acceptable). Presence of systemic disease that can cause low back pain (endometriosis, prostatitis, chronic renal disease, recurrent urinary tract infections, or other acute infections, not including simple upper respiratory infections without significant coughing). Pending litigation involving back injury. Back related disability. Lumbar laminectomy. Subjects cannot have participated in other research studies within 3 months of starting this study.

Sites / Locations

  • Pain and Rehabilitation Medicine

Outcomes

Primary Outcome Measures

Numerical pain rating scale

Secondary Outcome Measures

Pain pressure threshold as determined by the Fischer algometer
Number of tender regions, taut bands, reproduction of usual and referred pain, recorded as present or absent
Range of motion as measured by inclinometer
Roland Morris Back Pain Disability score
Short Form-36 score
Daily count of analgesics taken
Pain diary, rating low back pain as none, mild, moderate, or severe

Full Information

First Posted
August 14, 2006
Last Updated
April 17, 2007
Sponsor
Pain and Rehabilitation Medicine
Collaborators
Ferris Mfg. Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT00364065
Brief Title
Study to Evaluate Ferris PainWrap in the Treatment of Chronic Low Back Pain
Official Title
A Randomized, Controlled, Double-Blind, Pilot Study to Evaluate Ferris PainWrap, a Semipermeable Hydrophilic Polymeric Membrane, in the Treatment of Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pain and Rehabilitation Medicine
Collaborators
Ferris Mfg. Corp.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Ferris PainWrap
Primary Outcome Measure Information:
Title
Numerical pain rating scale
Secondary Outcome Measure Information:
Title
Pain pressure threshold as determined by the Fischer algometer
Title
Number of tender regions, taut bands, reproduction of usual and referred pain, recorded as present or absent
Title
Range of motion as measured by inclinometer
Title
Roland Morris Back Pain Disability score
Title
Short Form-36 score
Title
Daily count of analgesics taken
Title
Pain diary, rating low back pain as none, mild, moderate, or severe

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
Inclusion Criteria: English speakers, necessary to understand the protocol and communicate observations to the investigators Low back pain of 3 months or longer. Acceptable conditions include non-specific low back pain or pain associated with lumbar spondylosis without neurological impairment associated with the stenosis. Numerical Pain Rating Scale value of 4.5 or higher, estimated for the past week where 0=no pain and 10=worst possible pain. Pain must interfere in some way with daily activities, assessed by Roland and Morris Disability Survey. Beck Depression Inventory score of 20 or less. Physical examination findings of tenderness, muscle spasm or taut bands, or myofascial trigger points in the low back region. The low back region is defined as the lumbosacral region, below the 12th thoracic vertebra down to the sacro-coccygeal junction, and extending laterally to the plane of the lumbar vertebral transverse processes. Exclusion Criteria: Pregnancy NPR rating score of less than 4.5. Neurologic impairment in the legs (absent knee or ankle deep tendon reflexes, dermatome sensory loss or weakness) that indicates lumbar radiculopathy. Presence of cancer (previous diagnosis of cancer, or treated cancer with no sign of recurrence for 5 years is acceptable). Presence of systemic disease that can cause low back pain (endometriosis, prostatitis, chronic renal disease, recurrent urinary tract infections, or other acute infections, not including simple upper respiratory infections without significant coughing). Pending litigation involving back injury. Back related disability. Lumbar laminectomy. Subjects cannot have participated in other research studies within 3 months of starting this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D Gerwin, MD
Organizational Affiliation
Assistant Professor, Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain and Rehabilitation Medicine
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States

12. IPD Sharing Statement

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

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