Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica (ACT FAST)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Corticosteroid Taper for Acute Sciatica Treatment (The ACT FAST Study)|
- Oswestry Disability Index, v2 [ Time Frame: Baseline, Week 3 follow-up ] [ Designated as safety issue: No ]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 3 follow-up ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2008|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Participants will receive a 15-day tapering course of prednisone capsules.
For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.
Placebo Comparator: Placebo
Participants will receive a 15-day course of placebo capsules.
Placebo capsules will look the same as the study medication but will not contain active medicine.
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 part of the study. At Week 6, participants will be called at home for a telephone interview and again answer questions about their general health and wellness; this telephone call will last about 20 minutes. If they continue to have considerable pain, they will be offered a second ESI as part of the study.
At Week 12, an interviewer will phone participants to determine if their pain has decreased and whether they have been able to return to their normal activities. The telephone contact will last about 20 minutes. Additional information about their back problems will be obtained from their medical records and from Kaiser Permanente's computerized medical records on their use of health care and medicines for back problems. At Week 24, participants will attend an evaluation visit at the Spine Clinic to assess their progress and symptoms. At Week 52 (1 year from randomization), participants will undergo a final telephone interview.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668434
|United States, California|
|Kaiser Permanente Northern California, Redwood City|
|Redwood City, California, United States, 94063|
|Roseville, California, United States, 95661|
|Kaiser Permanente Northern California, San Jose|
|San Jose, California, United States, 94119|
|Principal Investigator:||Harley Goldberg, DO||Kaiser Permanente San Jose Medical Center|
|Principal Investigator:||Andrew L. Avins, MD, MPH||Kaiser Permanente Division of Research|
|Principal Investigator:||William Firtch, MD||Kaiser Permanente Redwood City|
|Principal Investigator:||Mark Tyburski, MD||Kaiser Permanente, Roseville|