Effectiveness Study of Physical Therapy as an Adjunct to a Lumbar Therapeutic Selective Nerve Root Block

July 7, 2009 updated by: University of Utah

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Intermountain Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Injection only
Participants receive a therapeutic selective nerve root block and advice to return to normal activity as tolerated.
Other: Lumbar injection
Patients are instructed to resume normal activity as tolerated.
Experimental: Injection plus physical therapy
Participants are referred to physical therapy within one week of receiving a therapeutic selective nerve root block. Physical therapy consists of end-range movements in a directional preference and/or mechanical traction to reduce radicular symptoms.
Other: Rehabilitation following lumbar injection
Participants are referred to an average of four weeks of physical therapy after receiving a lumbar injection. Physical therapy designed to include end-range directional preference exercises and/or mechanical traction to reduce lower extremity symptoms and progress activity tolerance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified Oswestry Disability Index
Time Frame: Baseline (pre-injection), 8 weeks (post-injection), 6 months post-injection
Baseline (pre-injection), 8 weeks (post-injection), 6 months post-injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Global Rating of Change
Time Frame: 8 weeks (post-injection) and 6 months (post-injection)
8 weeks (post-injection) and 6 months (post-injection)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Julie M Fritz, PhD, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

July 6, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

July 8, 2009

Last Update Submitted That Met QC Criteria

July 7, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00014476

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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