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

Study Overview
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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.

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

Conditions
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Sciatic Neuropathy, Radiculopathy, Intervertebral Disk Displacement

Intervention / Treatment
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* Other: Lumbar injection
* Other: Rehabilitation following lumbar injection


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Injection only<br>Participants receive a therapeutic selective nerve root block and advice to return to normal activity as tolerated. | Other: Lumbar injection<br>* Patients are instructed to resume normal activity as tolerated.<br>|
| Experimental: Injection plus physical therapy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sciatic neuropathy, physical therapy, spinal injections