The Value of Traction in Treatment of Lumbar Radiculopathy

Musculoskeletal Diseases Clinical Trial

Official title:

The Value of Traction in Treatment of Lumbar Radiculopathy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942227
• Other study ID #: 1008586
• Status: Completed
• Phase: Phase 3
• First received: July 16, 2009
• Last updated: January 11, 2013
• Start date: July 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Intervertebral Disk Displacement
• Musculoskeletal Diseases
• Neuromuscular Diseases
• Radiculopathy
• Sciatica
• Spinal Diseases

Intervention

Other:
• Physical therapy rehabilitation
Extension oriented exercises. Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine
• 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.

Locations

Country	Name	City	State
United States	Intermountain Healthcare, Rehab Agency	Salt Lake City	Utah

Sponsors (4)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	Empi, A DJO Company, University of Utah, Wilford Hall Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index		Baseline, 6 weeks, 6 months, 1year	No
Secondary	Global Rating of Change		Baseline, 6 weeks, 6 months, 1 year	No