The Value of Traction in Treatment of Lumbar Radiculopathy

NCT ID: NCT00942227

Last Updated: 2013-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-12-31

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.

Conditions

Sciatica; Radiculopathy; Spinal Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Intervertebral Disk Displacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Physical therapy rehabilitation

Intervention Type: OTHER

Extension oriented exercises. Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine

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.

Group Type: EXPERIMENTAL

Physical therapy rehabilitation

Intervention Type: OTHER

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.

Interventions

Physical therapy rehabilitation

Extension oriented exercises. Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

McKenzie exercises; Directional preference; Specific exercise; Saunders 3D Active Trac

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

59th Medical Wing

FED

Sponsor Role: collaborator

Empi, A DJO Company

INDUSTRY

Sponsor Role: collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Julie Fritz

Clinical Outcomes Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie M Fritz, PhD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Healthcare; University of Utah

Locations

Intermountain Healthcare, Rehab Agency

Salt Lake City, Utah, United States

Countries

United States

References

Thackeray A, Fritz JM, Childs JD, Brennan GP. The Effectiveness of Mechanical Traction Among Subgroups of Patients With Low Back Pain and Leg Pain: A Randomized Trial. J Orthop Sports Phys Ther. 2016 Mar;46(3):144-54. doi: 10.2519/jospt.2016.6238. Epub 2016 Jan 26.

Reference Type: DERIVED

PMID: 26813755 (View on PubMed)

Fritz JM, Thackeray A, Childs JD, Brennan GP. A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale. BMC Musculoskelet Disord. 2010 Apr 30;11:81. doi: 10.1186/1471-2474-11-81.

Reference Type: DERIVED

PMID: 20433733 (View on PubMed)

Other Identifiers

1008586

Identifier Type: -

Identifier Source: org_study_id