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

Phase 2

Completed

• Conditions: Sciatic Neuropathy; Radiculopathy; Intervertebral Disk Displacement
• Interventions: Other: Lumbar injection; Other: Rehabilitation following lumbar injection

• Registration Number: NCT00934284
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2009-07-06
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Injection only	Lumbar injection	Participants receive a therapeutic selective nerve root block and advice to return to normal activity as tolerated.
Injection plus physical therapy	Rehabilitation following lumbar injection	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.

Primary Outcome Measures

Name	Time	Method
Modified Oswestry Disability Index	Baseline (pre-injection), 8 weeks (post-injection), 6 months post-injection

Secondary Outcome Measures

Name	Time	Method
Global Rating of Change	8 weeks (post-injection) and 6 months (post-injection)

Trial Locations

Locations (1)

Intermountain Healthcare; 🇺🇸 Salt Lake City, Utah, United States