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

Radiculopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934284
• Other study ID #: 00014476
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2009
• Last updated: July 7, 2009
• Start date: January 2006
• Est. completion date: February 2008

Study information

• Verified date: July 2009
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Intervertebral Disk Displacement
• Radiculopathy
• Sciatic Neuropathy

Intervention

Other:
• Lumbar injection
Patients are instructed to resume normal activity as tolerated.
• 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.

Locations

Country	Name	City	State
United States	Intermountain Healthcare	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Oswestry Disability Index		Baseline (pre-injection), 8 weeks (post-injection), 6 months post-injection	No
Secondary	Global Rating of Change		8 weeks (post-injection) and 6 months (post-injection)	No