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

NCT00934284 | Completed FDA Drug

• 1 other identifier: 00014476
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

Sciatic Neuropathy; Radiculopathy; Intervertebral Disk Displacement

Keywords

sciatic neuropathy; physical therapy; spinal injections

Outcome Measures

Primary Outcomes (1)

• Modified Oswestry Disability Index

  Baseline (pre-injection), 8 weeks (post-injection), 6 months post-injection

Secondary Outcomes (1)

• Global Rating of Change

  8 weeks (post-injection) and 6 months (post-injection)

Study Arms (2)

Injection only

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

Other: Lumbar injection

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

Interventions

Lumbar injection OTHER

Patients are instructed to resume normal activity as tolerated.

Injection only

Rehabilitation following lumbar injection OTHER

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.

Injection plus physical therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Intermountain Healthcare

Salt Lake City, Utah, 84107, United States

Location

Related Publications (1)

• 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.

  PMID: 20864600 BACKGROUND

MeSH Terms

Conditions

Sciatic Neuropathy; Radiculopathy; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie M Fritz, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: January 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

US (1)