Clinical Trial: Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Corticosteroid Taper for Acute Sciatica Treatment (The ACT FAST Study)

Brief Summary: Sciatica is a condition that causes a sharp, burning pain in the back, buttock, and leg. The condition is caused by injury to or compression of the sciatic nerve, which is located in the back of the leg. This study will determine the effectiveness of the steroid prednisone in decreasing pain and improving function in people with sciatica.

Detailed Summary:

Sciatica is most often caused by a herniated disc in the lumbar region of the back and results from inflammation of the nerve roots as they exit the spine. It is a very common cause of back and leg pain, loss of function, and inability to work. Although sciatica is common, the effectiveness of current treatments is limited. Epidural steroid injections (ESIs), which can reduce inflammation of the nerve roots, are commonly used to decrease sciatica pain and restore normal function in patients. The exact effectiveness of ESIs, however, is unknown. If inflammation, and not compression, is the main cause of sciatica, it is reasonable to consider giving the steroid orally rather than by injection. If oral steroids prove effective, patients and clinicians will have access to a simple, inexpensive therapy that can be prescribed by primary care physicians without delay. This study will determine the effectiveness of the oral steroid prednisone in decreasing pain and improving function in people with sciatica.

Participants in this study will attend a screening visit at which they will answer questions about their health to determine eligibility, undergo a neurologic exam, and have a plain lower spine x-ray. An MRI of the lower spine will be performed for those who meet clinical eligibility. Participants whose MRI shows that a disc has ruptured in a specific way will be randomly assigned to receive either a 15-day course of prednisone capsules or a 15-day course of placebo capsules. Participants will take their assigned study medications in addition to their usual pain medications.

At Week 3, participants will return for a follow-up visit during which they will answer questions about their pain and general health and wellness. Participants who are still having considerable pain will be offered an epidural steroid injection (ESI) as a
Sponsor: Kaiser Permanente

Current Primary Outcome: Oswestry Disability Index, v2 [ Time Frame: Baseline, Week 3 follow-up ]

The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.


Original Primary Outcome: Changes in physical functioning [ Time Frame: Week 3 follow-up ]

Current Secondary Outcome:

  • Pain Numerical Rating Scale [ Time Frame: Baseline, Week 3 follow-up ]
    Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain.
  • Oswestry Disability Index, v2 [ Time Frame: Baseline, Week 52 follow-up ]
    The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.
  • Pain Numerical Rating Scale [ Time Frame: Baseline, Week 52 follow-up ]
    Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain.


Original Secondary Outcome:

  • Changes in pain [ Time Frame: Weeks 3 and 24 follow-up ]
  • Changes in physical functioning [ Time Frame: Week 24 follow-up ]
  • Effect of the following measures on treatment outcome: severity of baseline functional impairment and degree of lower-extremity weakness, length of time between onset of symptoms and study entry, and presence of multi-level disease [ Time Frame: Throughout the study ]


Information By: Kaiser Permanente

Dates:
Date Received: April 25, 2008
Date Started: November 2008
Date Completion:
Last Updated: April 9, 2015
Last Verified: April 2015