Lumbar Transforaminal Epidural Corticosteroid Injection(s) Versus Defined Physical Therapy
|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: NCT01443819|
Recruitment Status : Terminated (recruitment problem)
First Posted : September 30, 2011
Last Update Posted : December 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Radiculopathy||Other: Lumbar Transforaminal Epidural Corticosteroid Injection Other: Physical Therapy Other: Observation||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Prospective Study of Lumbar Transforaminal Epidural Corticosteroid Injection(s) Versus Defined Physical Therapy for the Treatment of Subacute Lumbar Radicular Pain Due to Disc Protrusion|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
|Lumbar Transforaminal Epidural Corticosteroid Injection||
Other: Lumbar Transforaminal Epidural Corticosteroid Injection
Injection: Anesthetic/corticosteroid (per randomization); repeat 1-3 times if clinically indicated.
The following drugs will be used for this procedure: 80mg Depo-Medrol and 1% lidocaine. These drugs used for the epidural injections are local anesthetic numbing medicines and cortisone/steroid anti-inflammatory medicines.
Other: Physical Therapy
Physical therapy carried out per protocol; 2-3 times per week for a total of 12 treatment sessions (excluding initial evaluation, including exit evaluation, minimum attendance 8/12) to be completed by 6 weeks from initiation of care (within study).
Please note: There will be another PT evaluation at the end of 6 weeks.
If subject declines then inquire about enrolment in the observational cohort. Participants in this group (Cohort) will chose their treatment (per-protocol physical therapy, injections, or both) after consulting with their physicians.
- Visual Analog Score [ Time Frame: 12months ]
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): NCT01443819
|United States, California|
|Spinal Diagnostics and Treatment Center|
|Daly City, California, United States, 94015|
|Comprehensive Spine and Sport|
|Mill Valley, California, United States, 94941|
|Stanford University Medicine Outpatient Center|
|Redwood City, California, United States, 94063|
|Principal Investigator:||Matthew Smuck, MD||Stanford University|