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Completed

NCT Number: NCT00942227

The Value of Traction in Treatment of Lumbar Radiculopathy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical therapy rehabilitation

Other

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

Primary outcomes

  1. Oswestry Disability Index

    Time frame: Baseline, 6 weeks, 6 months, 1year

Secondary outcomes

  1. Global Rating of Change

    Time frame: Baseline, 6 weeks, 6 months, 1 year

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

  • 59th Medical Wing
  • Empi, A DJO Company
  • University of Utah

Registry information

Official study title

The Value of Traction in Treatment of Lumbar Radiculopathy.

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2009
Registry last updated
Jan 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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