Clinical trial NCT00934284: Effectiveness Study of Physical Therapy As an Adjunct to a Lumbar Therapeutic Selective Nerve Root Block
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sciatic Neuropathy
Radiculopathy
Intervertebral Disk Displacement
Keywords: sciatic neuropathy
physical therapy
spinal injections
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Modified Oswestry Disability Index
timeFrame: Baseline (pre-injection), 8 weeks (post-injection), 6 months post-injection
Secondary outcomes:
measure: Global Rating of Change
timeFrame: 8 weeks (post-injection) and 6 months (post-injection)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Intermountain Healthcare
state: Utah
Study officials:
affiliation: Associate Professor
name: Julie M Fritz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.