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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
Sponsor:
Information provided by (Responsible Party):
Matthew W Smuck, Stanford University

Brief Summary:
The purpose of this research study is to look at two of the common forms of treatment for this condition: physical therapy and epidural steroid injection. The investigators are attempting to evaluate whether or not physical therapy alone, or epidural steroid injections alone, are effective in treating this condition. The investigators will also try to determine whether or not one of these treatments is better than the other for the treatment of herniated discs with nerve injury (radiculopathy).

Condition or disease Intervention/treatment Phase
Lumbar Radiculopathy Other: Lumbar Transforaminal Epidural Corticosteroid Injection Other: Physical Therapy Other: Observation Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.


Physical Therapy 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.


Cohort observational Other: Observation
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.




Primary Outcome Measures :
  1. Visual Analog Score [ Time Frame: 12months ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient inclusion highlights: L4-5 or L5-S1 HNP with leg>back pain; duration < 12 weeks.

  1. Low back pain episode less than or equal to 12 weeks in duration, within the current pain episode. This may be the initial pain episode or the onset of a most recent episode of pain, preceded by at least a six month pain free interval.
  2. Visual analog score (VAS) or screening Likert pain scale score three day average and present pain of at least four/ten at baseline.
  3. Age 18 to 64.
  4. Subjects will have focal disc herniation with unilateral radicular/neurological deficits or correlating radicular symptoms. These radicular symptoms/signs are defined as pain or paresthesias below the knee, pain reproduction with straight-leg-raising and/or extension or quadrant maneuvers, and radicular pattern sensory, reflex or strength changes. These symptoms will be consistent with their level of nerve root impingement and will primarily involve the L5 and/or S1 roots.
  5. Those with canal and foraminal compromise due to disc herniation at L4-5 with L5 > L4 signs and symptoms WILL be included.

Exclusion Criteria:

  1. Litigation.
  2. Workers compensation.
  3. Those receiving remuneration for their pain, e.g. disability.
  4. Back pain greater than leg pain.
  5. Scoliosis of > 15 degrees
  6. Those unable to read English and complete the assessment instruments.
  7. Spondylolysis, with or without spondylolithesis, degenerative spondylolithesis, or stenosis due primarily to degenerative bony or soft tissue changes.
  8. Systemic inflammatory arthritis (e.g. rheumatoid, lupus).
  9. Addictive behaviour, severe clinical depression, or psychotic features.
  10. Significant lower extremity pathology that effects gait.
  11. Sustained cervical or thoracic pain that is present at a level >4/10 on VAS.
  12. Possible pregnancy or other reason that precludes the use of fluoroscopy.
  13. Prior lumbar surgery
  14. Prior epidural steroid injections for treatment of current episode or within the prior year
  15. Bilateral radicular signs/symptoms (< 90% laterality of pain intensity or bilateral neurological signs)
  16. No more than 4 PT sessions for current episode

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): NCT01443819


Locations
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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
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Matthew Smuck, MD Stanford University

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Responsible Party: Matthew W Smuck, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01443819     History of Changes
Other Study ID Numbers: SU-09232011-8446
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015
Keywords provided by Matthew W Smuck, Stanford University:
Radiculopathy
Transforaminal
Disc Protrusion
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases