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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
Sponsor:
Collaborators:
University of Utah
59th Medical Wing
Empi, A DJO Company
Information provided by (Responsible Party):
Julie Fritz, Intermountain Health Care, Inc.

Tracking Information
First Submitted Date  ICMJE July 16, 2009
First Posted Date  ICMJE July 20, 2009
Last Update Posted Date January 14, 2013
Study Start Date  ICMJE July 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2009)
Oswestry Disability Index [ Time Frame: Baseline, 6 weeks, 6 months, 1year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2009)
Global Rating of Change [ Time Frame: Baseline, 6 weeks, 6 months, 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Value of Traction in Treatment of Lumbar Radiculopathy
Official Title  ICMJE The Value of Traction in Treatment of Lumbar Radiculopathy.
Brief Summary 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

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:

  1. 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.
  2. Compare the overall effectiveness of addition of a traction component to a standard physical therapy intervention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sciatica
  • Radiculopathy
  • Spinal Diseases
  • Musculoskeletal Diseases
  • Neuromuscular Diseases
  • Intervertebral Disk Displacement
Intervention  ICMJE
  • Other: Physical therapy rehabilitation
    Extension oriented exercises. Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine
    Other Names:
    • McKenzie exercises
    • Directional preference
    • Specific exercise
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Physical therapy rehabilitation
  • 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.
    Intervention: Other: Physical therapy rehabilitation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2009)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    1. Positive ipsilateral or contralateral straight leg raise test (reproduction of leg symptoms with straight leg raise < 70 degrees)
    2. Sensory deficit to pinprick on the ipsilateral lower extremity
    3. Diminished strength of a myotome (hip flexion, knee extension, ankle dorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lower extremity
    4. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00942227
Other Study ID Numbers  ICMJE 1008586
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julie Fritz, Intermountain Health Care, Inc.
Study Sponsor  ICMJE Intermountain Health Care, Inc.
Collaborators  ICMJE
  • University of Utah
  • 59th Medical Wing
  • Empi, A DJO Company
Investigators  ICMJE
Principal Investigator: Julie M Fritz, PhD Intermountain Healthcare; University of Utah
PRS Account Intermountain Health Care, Inc.
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP