- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00704210
Effectiveness of Mechanical Decompression for Low Back Pain Relief (SpiDERS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Low back pain (LBP) is a common medical problem and a challenging condition to treat. This study will investigate the effectiveness of a conservative treatment approach for chronic LBP. To this point few treatment approaches specifically address the resolution of underlying pathologies leading to a high probability of recurrence of LBP. Further, current treatment options for lumbar disc pathology have been of limited demonstrated effectiveness. The purpose of this study is to determine whether a non-surgical therapeutic approach designed to effect intervertebral widening and allow for reduction of disc protrusion will reduce patients' pain and improve their activity levels.
The study will assess whether a computer-assisted traction treatment [decompression] protocol results in improvement in patient pain levels and daily activity levels. Further, to determine if such treatment results in intervertebral widening and reduction of any disc protrusions as demonstrated by direct imaging of the lumbar spine. A double-blind (treatment vs. sham treatment) design will be employed
Specific Aims To study the effectiveness of decompression therapy for LBP patients with lumbar disc herniation and degenerative disc problems.
To demonstrate that decompression therapy for LBP patients results in a demonstrated reduction in levels of reported pain.
To demonstrate that decompression therapy for LBP patients results in a demonstrated greater return to daily activities.
To demonstrate that decompression therapy for LBP patients results in increased intervertebral space and reduced disk protrusion (if present) as measured by MRI.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non-specific LBP of at least 6 weeks duration with no evidence of underlying disease or anatomic abnormalities,
- Applicants may have pain radiating to their legs.
Exclusion Criteria:
- Any episode of Acute LBP within the last 6 weeks or less
- Recent Fractures, less than 8 weeks of any bone
- Tumors of any type including soft tissue tumors, myeloma, malignant or documented tumors of any type
- Gross osteoporosis,
- Spondylolisthesis grade 2 and above,
- Hardware fixation, spine fixation or other boney fusion
- Obesity as defined by a BMI greater than 35, body weight over 287 pounds,
- Contra-indication for MRJ assessment,
- Pregnancy,
- neurologic deficits,
- bowel or bladder incontinence,
- progressive lower extremity weakness,
- need for narcotic pain medications for other conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: B
Group B will receive sham decompression treatment (i.e.
tension not exceeding 15 lbs) for 30 minutes and ice treatment for 15 minutes once a day during each treatment session.
No incremental increases will be used for Group B.
|
For Group A (the treated group) the following tension adjustments will be used: starting treatment tension will equal 1/4 body weight minus 10 lbs.
Incremental increases of 4 lbs.
per session will be implemented until optimum tensions are reached, which would be a maximum of ¼ body weight plus 25 lbs, unless distraction tensions cause discomfort, which would require a reduction of the tensions applied.
Group B will receive sham decompression treatment (i.e.
tension not exceeding 15 lbs) for 30 minutes and ice treatment for 15 minutes once a day during each treatment session.
No incremental increases will be used for Group B.
|
Experimental: A
For Group A (the treated group) the following tension adjustments will be used: starting treatment tension will equal 1/4 body weight minus 10 lbs.
Incremental increases of 4 lbs.
per session will be implemented until optimum tensions are reached, which would be a maximum of ¼ body weight plus 25 lbs, unless distraction tensions cause discomfort, which would require a reduction of the tensions applied.
|
For Group A (the treated group) the following tension adjustments will be used: starting treatment tension will equal 1/4 body weight minus 10 lbs.
Incremental increases of 4 lbs.
per session will be implemented until optimum tensions are reached, which would be a maximum of ¼ body weight plus 25 lbs, unless distraction tensions cause discomfort, which would require a reduction of the tensions applied.
Group B will receive sham decompression treatment (i.e.
tension not exceeding 15 lbs) for 30 minutes and ice treatment for 15 minutes once a day during each treatment session.
No incremental increases will be used for Group B.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain will be measured using a 0-100 visual analog scale.
Time Frame: 19 weeks
|
19 weeks
|
Functional activity will be measured using the Roland Morris activity scale
Time Frame: 19 weeks
|
19 weeks
|
MRI outcome measures include thickness of disc (disc height, intervertebral space), extent of disc bulging, intervertebral alignment.
Time Frame: 19 weeks
|
19 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physical and social activities and quality of life will be measured with the COOP
Time Frame: 19 weeks
|
19 weeks
|
Functional health will be measured with the SF-36
Time Frame: 19 weeks
|
19 weeks
|
Depression will be measured using the Geriatric Depression Scale (GDS)
Time Frame: 19 weeks
|
19 weeks
|
Treatment satisfaction will be measured using a 5-point Likert scale.
Time Frame: 19 weeks
|
19 weeks
|
Reduction in pain medication usage
Time Frame: 19 weeks
|
19 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: William D Grant, EdD, State University of New York - Upstate Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBPHS 5379
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
-
Universidade Federal do PiauíFoundation for Research Support of the State of PiauíCompletedLow Back Pain, Recurrent | Chronic Low Back PainBrazil
-
Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedChronic Low Back Pain | Mechanical Low Back PainUnited States
-
University of ExtremaduraCompletedChronic Low Back Pain | Postural Low Back PainSpain
-
Université du Québec à Trois-RivièresCompletedChronic Low Back Pain | Mechanical Low Back PainCanada