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

NCT ID: NCT00934284

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Sciatic Neuropathy Radiculopathy Intervertebral Disk Displacement

Keywords

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sciatic neuropathy physical therapy spinal injections

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Injection only

Participants receive a therapeutic selective nerve root block and advice to return to normal activity as tolerated.

Lumbar injection

Intervention Type OTHER

Patients are instructed to resume normal activity as tolerated.

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.

Rehabilitation following lumbar injection

Intervention Type OTHER

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.

Interventions

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Lumbar injection

Patients are instructed to resume normal activity as tolerated.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Anne Thackeray

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie M Fritz, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Intermountain Healthcare

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Thackeray A, Fritz JM, Brennan GP, Zaman FM, Willick SE. A pilot study examining the effectiveness of physical therapy as an adjunct to selective nerve root block in the treatment of lumbar radicular pain from disk herniation: a randomized controlled trial. Phys Ther. 2010 Dec;90(12):1717-29. doi: 10.2522/ptj.20090260. Epub 2010 Sep 23.

Reference Type BACKGROUND
PMID: 20864600 (View on PubMed)

Other Identifiers

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00014476

Identifier Type: -

Identifier Source: org_study_id