The Value of Traction in Treatment of Lumbar Radiculopathy

NCT00942227 | Completed Phase 3

• 1 other identifier: 1008586
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Sciatica; Radiculopathy; Physical therapy modalities; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  Baseline, 6 weeks, 6 months, 1year

Secondary Outcomes (1)

• Global Rating of Change

  Baseline, 6 weeks, 6 months, 1 year

Study Arms (2)

Extension oriented treatment approach

ACTIVE COMPARATOR

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.

Other: Physical therapy rehabilitation

Mechanical traction plus extension-oriented treatment

EXPERIMENTAL

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.

Other: Physical therapy rehabilitation

Interventions

Physical therapy rehabilitation OTHER

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

Also known as: McKenzie exercises, Directional preference, Specific exercise

Extension oriented treatment approach

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• University of Utah: collaborator
• 59th Medical Wing: collaborator
• Empi, A DJO Company: collaborator

Study Sites (1)

Intermountain Healthcare, Rehab Agency

Salt Lake City, Utah, 84119, United States

Location

Related Publications (2)

• 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.

  PMID: 26813755 DERIVED

• 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.

  PMID: 20433733 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases; Hernia; Pathological Conditions, Anatomical

Study Officials

• Julie M Fritz, PhD

  Intermountain Healthcare; University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Outcomes Research Scientist

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 20, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 14, 2013

Record last verified: 2013-01

Locations

US (1)