The Value of Traction in Treatment of Lumbar Radiculopathy

Last updated: January 11, 2013
Sponsor: Intermountain Health Care, Inc.
Overall Status: Completed

Phase

3

Condition

Dystonias

Sciatica

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT00942227
1008586
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Chief complaint of pain and/or paresthesia in the lumbar spine with a distribution ofsymptoms that has extended distal to the gluteal fold on at least one lower extremitywithin 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 ofleg 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, ankledorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lowerextremity

  4. Diminished lower extremity reflex (Quadriceps or Achilles) of the symptomaticlower extremity

Exclusion

Exclusion Criteria:

  • Red flags noted in the patient's general medical screening questionnaire (i.e., tumor,metabolic diseases, RA, osteoporosis, spinal compression fracture, prolonged historyof steroid use, etc.)

  • Evidence of central nervous system involvement, to include symptoms of cauda equinasyndrome (i.e., loss of bowel/bladder control or saddle region paresthesia) or thepresence 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 ofthe 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

Study Design

Total Participants: 120
Study Start date:
July 01, 2009
Estimated Completion Date:
December 31, 2012

Study 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.

Connect with a study center

  • Intermountain Healthcare, Rehab Agency

    Salt Lake City, Utah 84119
    United States

    Site Not Available

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