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Clinical Trials/NCT00934284
NCT00934284
Completed
Phase 2

Effectiveness of Physical Therapy As an Adjunct to a Selective Nerve Root Block in the Treatment of Lumbar Radicular Pain from Disk Herniation

University of Utah1 site in 1 country44 target enrollmentJanuary 2006

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Sciatic Neuropathy
Sponsor
University of Utah
Enrollment
44
Locations
1
Primary Endpoint
Modified Oswestry Disability Index
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to determine if participation in physical therapy in conjunction with a selective nerve root block in the lumbar spine is more effective than just receiving the injection alone for patients with low back and leg pain from a disk herniation (sciatica).

Detailed Description

Recent reviews report moderate to strong evidence for short-term relief but limited evidence for long-term improvement. Anecdotal reports and case studies suggest good outcomes with various physical therapy interventions however well-designed research studies examining treatments in combination are lacking. The management of lumbar radicular pain often includes the combination of physical therapy and therapeutic selective nerve root blocks with the rationale that reducing inflammation and pain will permit greater participation in physical therapy. The effectiveness of this combination of treatment has not been studied and is the purpose of this pilot study.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
February 2008
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anne Thackeray

PhD

University of Utah

Eligibility Criteria

Inclusion Criteria

  • MRI evidence of disk herniation in the lumbar spine consistent with clinical presentation
  • Pain and/or paresthesia in the lumbar spine and a distribution extending distal to the gluteal fold within 24 hours of enrollment
  • Scheduled to receive a therapeutic selective nerve root block

Exclusion Criteria

  • Any lumbar surgery within six months of the baseline examination
  • Any prior lumbar surgery involving fusion
  • Medical red flags indicating a serious pathology such as neoplasm, infection, or fracture

Outcomes

Primary Outcomes

Modified Oswestry Disability Index

Time Frame: Baseline (pre-injection), 8 weeks (post-injection), 6 months post-injection

Secondary Outcomes

  • Global Rating of Change(8 weeks (post-injection) and 6 months (post-injection))

Study Sites (1)

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