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

Stopped early · Phase 3

Conditions studied: Lumbar Radiculopathy

In brief

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).

Key facts

Study ID

NCT01443819

Run by

Stanford University

People needed

5

Starts

2011-05-01

Expected to finish

2013-02-01

Last updated by the study team

2022-06-30

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient inclusion highlights: L4-5 or L5-S1 HNP with leg>back pain; duration < 12 weeks.
• 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.
• Visual analog score (VAS) or screening Likert pain scale score three day average and present pain of at least four/ten at baseline.
• Age 18 to 64.
• 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.
• Those with canal and foraminal compromise due to disc herniation at L4-5 with L5 > L4 signs and symptoms WILL be included.

You may not qualify if…

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

Where it is running

• Spinal Diagnostics and Treatment Center — Daly City, California, United States
• Comprehensive Spine and Sport — Mill Valley, California, United States
• Stanford University Medicine Outpatient Center — Redwood City, California, United States

Full record on ClinicalTrials.gov

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