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

Primary Purpose

Sciatic Neuropathy, Radiculopathy, Intervertebral Disk Displacement

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lumbar injection
Rehabilitation following lumbar injection
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sciatic Neuropathy focused on measuring sciatic neuropathy, physical therapy, spinal injections

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intermountain Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Injection only

Injection plus physical therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Modified Oswestry Disability Index

Secondary Outcome Measures

Global Rating of Change

Full Information

First Posted
July 6, 2009
Last Updated
July 7, 2009
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT00934284
Brief Title
Effectiveness Study of Physical Therapy as an Adjunct to a Lumbar Therapeutic Selective Nerve Root Block
Official Title
Effectiveness of Physical Therapy as an Adjunct to a Selective Nerve Root Block in the Treatment of Lumbar Radicular Pain From Disk Herniation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Utah

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatic Neuropathy, Radiculopathy, Intervertebral Disk Displacement
Keywords
sciatic neuropathy, physical therapy, spinal injections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injection only
Arm Type
Active Comparator
Arm Description
Participants receive a therapeutic selective nerve root block and advice to return to normal activity as tolerated.
Arm Title
Injection plus physical therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lumbar injection
Intervention Description
Patients are instructed to resume normal activity as tolerated.
Intervention Type
Other
Intervention Name(s)
Rehabilitation following lumbar injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Oswestry Disability Index
Time Frame
Baseline (pre-injection), 8 weeks (post-injection), 6 months post-injection
Secondary Outcome Measure Information:
Title
Global Rating of Change
Time Frame
8 weeks (post-injection) and 6 months (post-injection)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie M Fritz, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Healthcare
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20864600
Citation
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.
Results Reference
derived

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

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