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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00934284
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : July 8, 2009
Sponsor:
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Sciatic Neuropathy Radiculopathy Intervertebral Disk Displacement Other: Lumbar injection Other: Rehabilitation following lumbar injection Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Active Comparator: 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.

Experimental: 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.




Primary Outcome Measures :
  1. Modified Oswestry Disability Index [ Time Frame: Baseline (pre-injection), 8 weeks (post-injection), 6 months post-injection ]

Secondary Outcome Measures :
  1. Global Rating of Change [ Time Frame: 8 weeks (post-injection) and 6 months (post-injection) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934284


Locations
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United States, Utah
Intermountain Healthcare
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Julie M Fritz, PhD Associate Professor
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julie M. Fritz, PhD, PT, ATC, University of Utah
ClinicalTrials.gov Identifier: NCT00934284    
Other Study ID Numbers: 00014476
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: July 8, 2009
Last Verified: July 2009
Keywords provided by University of Utah:
sciatic neuropathy
physical therapy
spinal injections
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Radiculopathy
Sciatic Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Mononeuropathies