Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica (ACT FAST)

• ClinicalTrials.gov Identifier: NCT00668434
• Recruitment Status: Completed
• First Posted: April 29, 2008
• Results First Posted: April 28, 2015
• Last Update Posted: April 28, 2015
• Sponsor: Kaiser Permanente
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Information provided by (Responsible Party): Kaiser Permanente

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sciatica	Drug: Prednisone; Drug: Placebo	Phase 2

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 269 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Corticosteroid Taper for Acute Sciatica Treatment (The ACT FAST Study)
• Study Start Date: November 2008
• Actual Primary Completion Date: September 2012
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Prednisone; Participants will receive a 15-day tapering course of prednisone capsules.	Drug: Prednisone; 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.	Drug: Placebo; Placebo capsules will look the same as the study medication but will not contain active medicine.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Seeks care at a Kaiser Permanente clinic spine care specialist at the San Jose, Redwood City, or Roseville site
• Complains of low back pain and functionally incapacitating leg pain extending below the knee with a nerve root distribution
• 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:

• Onset of sciatica symptoms occurred more than 3 months before study entry
• Cauda equina syndrome
• 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
• Pregnant or breastfeeding
• Active peptic ulcer disease
• History of intolerance to steroid therapy
• Bleeding diathesis or anticoagulant therapy
• Ongoing litigation or workers compensation claim for low back pain or sciatica
• Underwent previous lumbar surgery
• Received epidural steroid injection (ESI) within the 12 months before study entry
• Unable to read or speak English
• Progressive or severe motor loss

Contacts and Locations

Locations

United States, California

Kaiser Permanente Northern California, Redwood City

Redwood City, California, United States, 94063

Kaiser Permanente

Roseville, California, United States, 95661

Kaiser Permanente Northern California, San Jose

San Jose, California, United States, 94119

Sponsors and Collaborators

Kaiser Permanente

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Goldberg H, Firtch W, Tyburski M, Pressman A, Ackerson L, Hamilton L, Smith W, Carver R, Maratukulam A, Won LA, Carragee E, Avins AL. Oral steroids for acute radiculopathy due to a herniated lumbar disk: a randomized clinical trial. JAMA. 2015 May 19;313(19):1915-23. doi: 10.1001/jama.2015.4468.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT00668434
• Other Study ID Numbers: R01AR053960 ( U.S. NIH Grant/Contract ); R01AR053960 ( U.S. NIH Grant/Contract )
• First Posted: April 29, 2008
• Results First Posted: April 28, 2015
• Last Update Posted: April 28, 2015
• Last Verified: April 2015

Keywords provided by Kaiser Permanente:

Back Pain; Leg Pain

Additional relevant MeSH terms:

Sciatica; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Prednisone; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents