Low Back PainPhase 4NCT00364065
Study to Evaluate Ferris PainWrap in the Treatment of Chronic Low Back Pain
A Phase 4 study testing Ferris PainWrap in people with Low Back Pain, run by Pain and Rehabilitation Medicine at 1 site in United States.
Trial summary
The purpose of this study is to see if the Ferris PainWrap is effective in the treatment of chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Ferris PainWrap
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Apr 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Back related disability.
- Lumbar laminectomy.
- Subjects cannot have participated in other research studies within 3 months of starting this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pain and Rehabilitation Medicine
Bethesda, Maryland, 20814
About this study
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
The purpose of this study is to see if the Ferris PainWrap is effective in the treatment of chronic low back pain.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Ferris PainWrap
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferris PainWrapDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Daily count of analgesics taken
Pain diary, rating low back pain as none, mild, moderate, or severe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startSep 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Pain and Rehabilitation Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ferris Mfg. Corp.
- Investigators
- Robert D Gerwin, MD, Principal investigator, Assistant Professor, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364065
- Sponsor's protocol ID
- NA_00003008
- Status last verified
- Apr 2007
- First submitted
- 14 Aug 2006
- Last updated
- 18 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00364065
- Acronym / sponsor ID
- NA_00003008
- Conditions
- Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Pain and Rehabilitation MedicineUniversity, hospital or other
- Collaborators
- Ferris Mfg. Corp.
- Study start
- Sep 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferris PainWrap | Device | – |
Primary outcome
Numerical pain rating scale
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2007.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D Gerwin, MD principal investigator
Assistant Professor, Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferris PainWrap in people with Low Back Pain, run by Pain and Rehabilitation Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical pain rating scale. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2007.