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The Value of Traction in Treatment of Lumbar Radiculopathy
This study has been completed.
Sponsor:
Intermountain Health Care, Inc.
Collaborators:
University of Utah
Wilford Hall Medical Center
Empi, A DJO Company
Information provided by (Responsible Party):
Julie Fritz, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT00942227
First received: July 16, 2009
Last updated: January 11, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to determine the effectiveness of adding mechanical traction to standard physical therapy treatments for patients with low back pain.
| Condition | Intervention | Phase |
|---|---|---|
| Sciatica Radiculopathy Spinal Diseases Musculoskeletal Diseases Neuromuscular Diseases Intervertebral Disk Displacement | Other: Physical therapy rehabilitation | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
| Official Title: | The Value of Traction in Treatment of Lumbar Radiculopathy. |
Further study details as provided by Julie Fritz, Intermountain Health Care, Inc.:
Primary Outcome Measures:
- Oswestry Disability Index [ Time Frame: Baseline, 6 weeks, 6 months, 1year ]
Secondary Outcome Measures:
- Global Rating of Change [ Time Frame: Baseline, 6 weeks, 6 months, 1 year ]
| Enrollment: | 120 |
| Study Start Date: | July 2009 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Names:
|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Chief complaint of pain and/or paresthesia in the lumbar spine with a distribution of symptoms that has extended distal to the gluteal fold on at least one lower extremity within the past 24 hours based on the patient's self-report.
- Oswestry disability score of at least 20%
- Age at least 18 years and less than 60 years
-
At least one of the following signs of nerve root compression:
- Positive ipsilateral or contralateral straight leg raise test (reproduction of leg symptoms with straight leg raise < 70 degrees)
- Sensory deficit to pinprick on the ipsilateral lower extremity
- Diminished strength of a myotome (hip flexion, knee extension, ankle dorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lower extremity
- Diminished lower extremity reflex (Quadriceps or Achilles) of the symptomatic lower extremity
Exclusion Criteria:
- Red flags noted in the patient's general medical screening questionnaire (i.e., tumor, metabolic diseases, RA, osteoporosis, spinal compression fracture, prolonged history of steroid use, etc.)
- Evidence of central nervous system involvement, to include symptoms of cauda equina syndrome (i.e., loss of bowel/bladder control or saddle region paresthesia) or the presence of pathological reflexes (i.e., positive Babinski)
- Patient reports the complete absence of low back and leg symptoms when seated
- Recent surgery (< 6 months) to the lumbar spine or buttocks, or any fusion surgery of the lumbar spine or pelvis
- Recent (< 2 weeks) epidural steroid injection for low back and/or leg pain
- Current pregnancy
- Inability to comply with the treatment schedule
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942227
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942227
Locations
| United States, Utah | |
| Intermountain Healthcare, Rehab Agency | |
| Salt Lake City, Utah, United States, 84119 | |
Sponsors and Collaborators
Intermountain Health Care, Inc.
University of Utah
Wilford Hall Medical Center
Empi, A DJO Company
Investigators
| Principal Investigator: | Julie M Fritz, PhD | Intermountain Healthcare; University of Utah |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Julie Fritz, Clinical Outcomes Research Scientist, Intermountain Health Care, Inc. |
| ClinicalTrials.gov Identifier: | NCT00942227 History of Changes |
| Other Study ID Numbers: |
1008586 |
| Study First Received: | July 16, 2009 |
| Last Updated: | January 11, 2013 |
Keywords provided by Julie Fritz, Intermountain Health Care, Inc.:
|
Sciatica Radiculopathy Physical therapy modalities Rehabilitation |
Additional relevant MeSH terms:
|
Radiculopathy Neuromuscular Diseases Sciatica Musculoskeletal Diseases Spinal Diseases Intervertebral Disc Displacement Peripheral Nervous System Diseases Nervous System Diseases Neuralgia |
Pain Neurologic Manifestations Sciatic Neuropathy Mononeuropathies Signs and Symptoms Bone Diseases Hernia Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on September 21, 2017