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A Corticosteroid Taper For Acute Sciatica Treatment
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Corticosteroid Taper For Acute Sciatica Treatment
 
Region Sponsors
California - Northern
Kaiser Permanente
National Institute of Arthritis and Musculoskeleta
 
Acronym KP IRB No.
ACT FAST CN-06HGold-01-B
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
(Adult, Older Adult) with Sciatica
 
Purpose
Sciatica, also known as “acute radiculopathy”, is a sharp burning pain in the back, buttock and down the leg. It is most often a result of a herniated disc, (herniated lumbar nucleus pulposus) and results from inflammation of the nerve root(s) as they exit the spine. It is a very common cause of back and leg pain, loss of function and work absenteeism in the industrialized world. Although sciatica is common, the effectiveness of current treatments is limited. The purpose of this study is to evaluate whether treatment with a 15-day course of oral prednisone (a steroid medication) is effective in improving the physical functioning and in decreasing pain in patients with sciatica compared to treatment with an oral placebo (medication containing no active medicine) after three weeks of follow-up.
 
Detailed Description
Acute lumbar radiculopathy (also known as acute sciatica) due to a herniated lumbar intervertebral disc is one of the most common and disabling conditions affecting the spine. Current therapeutic approaches are generally supportive but ample evidence exists showing that much of the nerve-root pain and dysfunction may be primarily due to an inflammatory response. Anti-inflammatory therapy, therefore, might prove effective in ameliorating symptoms of a herniated nucleus pulposus (HNP). The use of a short course of oral steroids for patients with an acute HNP is a promising alternative to epidural steroid injections. While many clinicians use oral steroids for HNP, there are virtually no data to support their use. To understand the effect of oral steroids on functional status and pain, we are conducting a two-arm parallel randomized clinical trial of a 15-day tapering course of oral prednisone vs. a matched placebo for patients with acute HNP. All participants will have a documented compatible history, physical exam, and lumbar spine MRI to confirm the presence of an HNP. Those participants who show insufficient improvement after the initial treatment (at three weeks) will receive up to two epidural steroid injections (ESI) during follow-up. The primary outcome will be change in the Oswestry Disability Index from randomization to the three-week follow-up visit; secondary endpoints include a visual analogue pain scale, the Dallas Pain Questionnaire, and the SF-36. Participants will then be followed for six months to assess longer-term outcomes. The results of this study will provide crucial information about the benefits and risks of a short course of oral steroids for the treatment of patients with acute sciatica, potentially providing an important new intervention for this common and disabling condition.
 
Gender Age Limit
Male & Female 18 - 70 years
 
Inclusion Criteria
  • Seeks care at a Kaiser Permanente clinic spine care specialist at either the Roseville, San Jose or Redwood City, CA site
  • Complains of low back pain and functionally incapacitating leg pain extending below the knee with a nerve root distribution
  • Nerve root tension signs with or without neurologic abnormalities, fitting the level of the radiculopathy
  • Score of at least 20 on the modified Oswestry Disability Index
  • Appears, in the opinion of the study physician, to be very likely to have a herniated lumbar disc
  • MRI study confirms a herniated disc consistent with the signs and symptoms
 
Exclusion Criteria
  • Active cancer
  • Acute spinal fracture
  • Currently taking oral steroids
  • Diabetes mellitus and taking insulin or glycohemoglobin greater than 10%
  • Systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg
  • Underwent previous lumbar surgery
  • Onset of sciatica symptoms occurred more than 3 months before study entry
  • Received epidural steroid injection (ESI) within the 12 months before study entry

 
Keywords and/or Specific Medical Conditions
  • glucocorticoids
  • neuromuscular
  • leg pain
  • prednisone
  • mononeuropathis
  • R01AR053960 back pain
  • nervous system
  • sciatica
  • neuralgia
  • neurology (Neurological Disorders)
  • neurologic manifestations
  • Physical Medicine and Rehabilitation
  • Neurology (Neurological Disorders)
 
KP Clinical Facility
  • Redwood City Medical Center
  • Regional Locations-DOR
  • Roseville Medical Center-Rancho Cordova
  • Santa Teresa Medical Center-San Jose
 
Clinical Area
  • Neurology (Neurological Disorders)
  • Physical Medicine and Rehabilitation


Principal Investigator:
Andrew L Avins, MD
Contact Information:
- Luisa Hamilton
-Luisa.M.Hamilton@kp.org
-Regional Locations-DOR
- William Firtch, MD
-650-299-4741
-william.firtch@nsmtp.kp.org
-Redwood City Medical Center
- Mark D Tyburski, MD
-916-771-6664
-mark.tyburski@nsmtp.kp.org
-Roseville Medical Center


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