Status:
COMPLETED
Study to Evaluate Ferris PainWrap in the Treatment of Chronic Low Back Pain
Lead Sponsor:
Pain and Rehabilitation Medicine
Collaborating Sponsors:
Ferris Mfg. Corp.
Conditions:
Low Back Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 preva...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00364065
Start Date
September 1 2006
End Date
April 1 2007
Last Update
April 18 2007
Active Locations (1)
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1
Pain and Rehabilitation Medicine
Bethesda, Maryland, United States, 20814