The Value of Traction in Treatment of Lumbar Radiculopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00942227|
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : January 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Sciatica Radiculopathy Spinal Diseases Musculoskeletal Diseases Neuromuscular Diseases Intervertebral Disk Displacement||Other: Physical therapy rehabilitation||Phase 3|
Despite the opinions of clinical experts that patients who might benefit from traction may represent distinct sub-groups of patients, most studies have not attempted to narrow their inclusion criteria beyond loose definitions of 'acute' or 'chronic' symptoms. While these studies seem to indicate that traction interventions will be of little benefit when administered to large groups of patients without a prior attempt to select which patients are most likely to benefit, they are not sufficient to preclude the possibility that a subgroup of patients may benefit substantially from the intervention. Recent preliminary studies suggest a there exists a subgroup of patients with LBP that is likely to benefit from traction.
The two primary aims of this study are:
- Determine the validity of the previously-identified prediction criteria to identify patients highly likely to benefit from the addition of traction to a standard physical therapy intervention.
- Compare the overall effectiveness of addition of a traction component to a standard physical therapy intervention.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Value of Traction in Treatment of Lumbar Radiculopathy.|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Active Comparator: Extension oriented treatment approach
Extension exercises. Subjects are instructed in a progression of extension oriented movements for the lumbar spine. Manual therapy may be added to further increase extension movement and/or reduction of symptoms.
Other: Physical therapy rehabilitation
Extension oriented exercises. Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine
Experimental: Mechanical traction plus extension-oriented treatment
Mechanical lumbar traction will be utilized in addition to extension oriented exercises. Subjects are also instructed in a progression of extension oriented movements for the lumbar spine. Manual therapy may be added to increase extension movement and/or reduce radicular symptoms.
Other: Physical therapy rehabilitation
Mechanical lumbar traction will be applied with subjects in prone utilizing 40-60% of subject's body weight to create a distraction force in the lumbar spine. Following traction, subjects will be instructed in a progression of extension oriented exercises and manual therapy to increase extension as described for the comparator group.
Other Name: Saunders 3D Active Trac
- Oswestry Disability Index [ Time Frame: Baseline, 6 weeks, 6 months, 1year ]
- Global Rating of Change [ Time Frame: Baseline, 6 weeks, 6 months, 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942227
|United States, Utah|
|Intermountain Healthcare, Rehab Agency|
|Salt Lake City, Utah, United States, 84119|
|Principal Investigator:||Julie M Fritz, PhD||Intermountain Healthcare; University of Utah|