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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00668434
First received: April 25, 2008
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Sciatica
Drug: Prednisone
Drug: Placebo
Phase 2

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Changes in physical functioning [ Time Frame: Week 3 follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in pain [ Time Frame: Weeks 3 and 52 follow-up ] [ Designated as safety issue: No ]
  • Changes in physical functioning [ Time Frame: Week 52 follow-up ] [ Designated as safety issue: No ]
  • 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 multilevel disease [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 269
Study Start Date: November 2008
Study Completion Date: September 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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: B
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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, CA 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668434

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
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, CA
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00668434     History of Changes
Other Study ID Numbers: R01 AR053960, R01AR053960
Study First Received: April 25, 2008
Last Updated: October 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Kaiser Permanente:
Back Pain
Leg Pain

Additional relevant MeSH terms:
Sciatica
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 20, 2014