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

Effectiveness of Physical Therapy As an Adjunct to a Selective Nerve Root Block in the Treatment of Lumbar Radicular Pain from Disk Herniation

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).

Study Overview

• Status: Completed
• Conditions: Sciatic Neuropathy; Radiculopathy; Intervertebral Disk Displacement
• Intervention / Treatment: Other: Lumbar injection; Other: Rehabilitation following lumbar injection

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 Type: Observational
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Intermountain Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Individuals with low back pain, with clinical and imaging findings consistent with lumbar disk herniation, and scheduled to receive a selective nerve root block.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Injection only; Participants receive a therapeutic selective nerve root block and advice to return to normal activity as tolerated.	Other: Lumbar injection; 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Julie M Fritz, PhD, Associate professor

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: July 6, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (Estimated): July 8, 2009

Study Record Updates

• Last Update Posted (Actual): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: physical therapy; sciatic neuropathy; spinal injections
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Hernia; Mononeuropathies; Radiculopathy; Intervertebral Disc Displacement; Sciatic Neuropathy
• Other Study ID Numbers: 00014476

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No