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

NCT00364065 | Completed Phase 4

• 1 other identifier: NA_00003008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Numerical pain rating scale

Secondary Outcomes (7)

• 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

Interventions

Ferris PainWrap DEVICE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pain and Rehabilitation Medicine: lead
• Ferris Mfg. Corp.: collaborator

Study Sites (1)

Pain and Rehabilitation Medicine

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert D Gerwin, MD

  Assistant Professor, Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 14, 2006
• First Posted: August 15, 2006
• Study Start: September 1, 2006
• Study Completion: April 1, 2007
• Last Updated: April 18, 2007

Record last verified: 2007-04

Locations

US (1)