Trial Search Results

Lumbar Transforaminal Epidural Corticosteroid Injection(s) Versus Defined Physical Therapy

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University


  • Other: Lumbar Transforaminal Epidural Corticosteroid Injection
  • Other: Physical Therapy
  • Other: Observation


Phase 3


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

15. Bilateral radicular signs/symptoms (< 90% laterality of pain intensity or bilateral
   neurological signs)

16. No more than 4 PT sessions for current episode

Ages Eligible for Study

18 Years - 64 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ma Agnes Ith
Not Recruiting