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

This study has been completed.
Sponsor:
Collaborator:
Ferris Mfg. Corp.
Information provided by:
Pain and Rehabilitation Medicine
ClinicalTrials.gov Identifier:
NCT00364065
First received: August 14, 2006
Last updated: April 17, 2007
Last verified: April 2007
  Purpose

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


Condition Intervention Phase
Low Back Pain
Device: Ferris PainWrap
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Pain and Rehabilitation Medicine:

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

Estimated Enrollment: 20
Study Start Date: September 2006
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364065

Locations
United States, Maryland
Pain and Rehabilitation Medicine
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
Pain and Rehabilitation Medicine
Ferris Mfg. Corp.
Investigators
Principal Investigator: Robert D Gerwin, MD Assistant Professor, Johns Hopkins School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00364065     History of Changes
Other Study ID Numbers: NA_00003008
Study First Received: August 14, 2006
Last Updated: April 17, 2007
Health Authority: United States: Institutional Review Board
United States: Johns Hopkins Office of Human Research Protection

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014