The Value of Traction in Treatment of Lumbar Radiculopathy

Phase 3

Completed

• Conditions: Sciatica; Radiculopathy; Spinal Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Intervertebral Disk Displacement
• Interventions: Other: Physical therapy rehabilitation

• Registration Number: NCT00942227
• Lead Sponsor: Intermountain Health Care, Inc.

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-07-17
• Study First Posted: 2009-07-20
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extension oriented treatment approach	Physical therapy rehabilitation	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.
Mechanical traction plus extension-oriented treatment	Physical therapy rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	Baseline, 6 weeks, 6 months, 1year

Secondary Outcome Measures

Name	Time	Method
Global Rating of Change	Baseline, 6 weeks, 6 months, 1 year

Trial Locations

Locations (1)

Intermountain Healthcare, Rehab Agency; 🇺🇸 Salt Lake City, Utah, United States