The Value of Traction in Treatment of Lumbar Radiculopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Value of Traction in Treatment of Lumbar Radiculopathy.

Conditions
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Sciatica, Radiculopathy, Spinal Diseases, Musculoskeletal Diseases, Neuromuscular Diseases, Intervertebral Disk Displacement

Intervention / Treatment
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* Other: Physical therapy rehabilitation
* Other: Physical therapy rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extension oriented treatment approach<br>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<br>* Extension oriented exercises. Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine<br>* Other names: Specific exercise;|
| Experimental: Mechanical traction plus extension-oriented treatment<br>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<br>* 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.<br>* Other names: Saunders 3D Active Trac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index |  | Baseline, 6 weeks, 6 months, 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Rating of Change |  | Baseline, 6 weeks, 6 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sciatica, Radiculopathy, Physical therapy modalities, Rehabilitation