The Efficacy of Oral Steroids in the Treatment of Acute Sciatica

NCT00317447 | Completed Phase 3

• 1 other identifier: Oral Steroid Tx Acute Sciatica
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Sciatica (lumbosacral radiculopathy) is a common diagnosis in primary care, occurring in approximately one percent of all patients with acute low back pain. (1, 2) Traditional treatment generally involves pain control (acetominophen, NSAID's, or narcotics), activity as tolerated, and time. (1, 3-8 ) The general consensus is that fifty percent of patients with sciatica recover within six weeks, and that ninety percent are better in twelve weeks.(4, 8) Those patients with intractable pain or progressive neurologic symptoms usually receive epidural steroid injections and, if necessary, decompressive laminectomy or discectomy. (2, 8, 9) Low back pain and sciatica result in tremendous losses to our society in terms of decreased productivity and cost of treatment. (1, 12) Oral steroids are inexpensive and relatively safe medications that, if effective in reducing the pain and disability associated with sciatica, could improve the quality of patients' lives, and result in significant cost savings to society at large. We hypothesize that the use of oral steroids to treat acute sciatica will speed patients' recovery as measured by: changes in physical findings, rates of return to work and activities of daily living, pain and disability assessment scores, and decreases in the use of narcotic and non-steroidal anti-inflammatory drugs (NSAID's), and in the need for epidural injection or surgical intervention.

Conditions

Sciatica

Keywords

Sciatica; Lower back pain; Prednisone; Randomized, controlled clinical trial

Outcome Measures

Primary Outcomes (13)

• Physical examination findings:

• straight leg raising test (positive or negative)

• contralateral straight leg raising (positive or negative)

• knee and ankle stretch reflexes (0-3+)

• foot sensation (normal or decreased)

• strength (0-5) of quadriceps

• foot dorsiflexors

• foot plantar flexors

• ability to perform five heel lifts (0-5)

• Written instruments:

• HSQ 12 (Health Status Questionaire)(13)

• Roland-Morris Disability Questionaire (14)

• Roland-Morris Pain Rating Scale (14)

Secondary Outcomes (4)

• Number of hours/week of work

• Estimated percent of daily living activities subjects were able to accomplish

• Epidural steroid injection

• Surgical intervention

Interventions

Oral Prednisone DRUG

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A diagnosis of acute sciatica as determined by the principle investigator based on the following criteria:
• unilateral leg pain extending below the knee (with or without strength, sensory, or reflex changes); and
• a positive straight leg raising sign (defined as as pain radiating from the buttock to below the knee with elevation of the leg between zero and sixty degrees)
• recruited into the study within one week of the onset of symptoms

You may not qualify if:

• Current pregnancy
• A history of:
• diabetes renal failure upper gastro-intestinal bleed major psychiatric disease
• Presence of any 'red flag' symptoms suggestive of more serious underlying disease as defined by the United States Agency for Healthcare Policy Research document: "Acute Low Back Problems In Adults" (11) including:
• a history of cancer
• unexplained weight loss
• fever or chills
• night sweats
• a history of intravenous drug use, saddle anesthesia, bowel or bladder incontinence, bone pathology, or a Neurologic emergency.
• Any condition that the principle investigator thought might jeopardize the patient's safety

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser-Permanente

Santa Rosa, California, 95403, United States

Location

Related Publications (13)

• Frymoyer JW. Back pain and sciatica. N Engl J Med. 1988 Feb 4;318(5):291-300. doi: 10.1056/NEJM198802043180506. No abstract available.

  PMID: 2961994 BACKGROUND

• Scheer SJ, Radack KL, O'Brien DR Jr. Randomized controlled trials in industrial low back pain relating to return to work. Part 2. Discogenic low back pain. Arch Phys Med Rehabil. 1996 Nov;77(11):1189-97. doi: 10.1016/s0003-9993(96)90147-1.

  PMID: 8931535 BACKGROUND

• USDHHS, Agency for Health Care Policy and Research. Acute low back problems in adults. Rockville, MD: AHCPR; 1994. AHCPR pub number 95-0642

  BACKGROUND

• Daniels JM 2nd. Treatment of occupationally acquired low back pain. Am Fam Physician. 1997 Feb 1;55(2):587-96, 601-2.

  PMID: 9054226 BACKGROUND

• Deyo RA. Conservative therapy for low back pain. Distinguishing useful from useless therapy. JAMA. 1983 Aug 26;250(8):1057-62.

  PMID: 6224032 BACKGROUND

• Deyo RA. Back pain revisited. Newer thinking on diagnosis and therpapy. Consultant 1993 Feb:88-97

  BACKGROUND

• Griffin G, Tudiver F, Grant WD. Do NSAIDs help in acute or chronic low back pain? Am Fam Physician. 2002 Apr 1;65(7):1319-21. No abstract available.

  PMID: 11996413 BACKGROUND

• Weber H. The natural history of disc herniation and the influence of intervention. Spine (Phila Pa 1976). 1994 Oct 1;19(19):2234-8; discussion 2233. doi: 10.1097/00007632-199410000-00022.

  PMID: 7809761 BACKGROUND

• Kraemer J. Natural course and prognosis of intervertebral disc diseases. International Society for the Study of the Lumbar Spine Seattle, Washington, June 1994. Spine (Phila Pa 1976). 1995 Mar 15;20(6):635-9. doi: 10.1097/00007632-199503150-00001.

  PMID: 7604337 BACKGROUND

• Guo HR, Tanaka S, Halperin WE, Cameron LL. Back pain prevalence in US industry and estimates of lost workdays. Am J Public Health. 1999 Jul;89(7):1029-35. doi: 10.2105/ajph.89.7.1029.

  PMID: 10394311 BACKGROUND

• Radosevich DM. An abbreviated health status questionnaire: the HSQ12. The Newsletter of the Health Outcomes Institute. 1995;2:1-4

  BACKGROUND

• Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.

  PMID: 6222486 BACKGROUND

• Elashoff JD, NQuery Advisor Version 2.0, 2000, Statistical Solutions, Saugus MA

  BACKGROUND

MeSH Terms

Conditions

Sciatica; Low Back Pain

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Richard Holve, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2006
• First Posted: April 24, 2006
• Study Start: February 1, 2002
• Study Completion: April 1, 2004
• Last Updated: April 24, 2006

Record last verified: 2006-04

Locations

US (1)