Text Size

The Value of Traction in Treatment of Lumbar Radiculopathy

This study has been completed.
Sponsor:
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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Value of Traction in Treatment of Lumbar Radiculopathy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: Baseline, 6 weeks, 6 months, 1year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Rating of Change [ Time Frame: Baseline, 6 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]

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:
  • McKenzie exercises
  • Directional preference
  • Specific exercise
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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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:

    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
  Contacts and Locations
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

No publications provided by Intermountain Health Care, Inc.

Additional 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
Health Authority: United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
Sciatica
Radiculopathy
Physical therapy modalities
Rehabilitation

Additional relevant MeSH terms:
Intervertebral Disk Displacement
Musculoskeletal Diseases
Neuromuscular Diseases
Sciatica
Spinal Diseases
Radiculopathy
Bone Diseases
Hernia
Pathological Conditions, Anatomical
 Nervous System Diseases
Neuralgia
Pain
Neurologic Manifestations
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013