The Efficacy of Oral Steroids in the Treatment of Acute Sciatica

2014-08-27 03:45:04 | BioPortfolio


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.


Inclusion Criteria

To be included in this study patients had to have 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). Patients had to be between twenty and sixty years of age, and had to be entered in [recruited into] the study within one week of the onset of their symptoms.

Exclusion Criteria

Patients were excluded from the study if they were pregnant or had a history of diabetes, renal failure, upper gastro-intestinal bleed, or major psychiatric disease. Patients also had to be free of symptoms suggesting more serious underlying disease as defined by the United States Agency for Healthcare Policy Research document: “Acute Low Back Problems In Adults”. (11) “Red Flag” symptoms” included: 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. Additionally, patients could be excluded for any condition that the principle investigator thought might jeopardize their safety.

Randomization and Blinding

Once the diagnosis of acute sciatica had been confirmed, subjects were randomized to receive either a nine day tapering course of prednisone or placebo capsules. The principle investigator and research nurse were blinded as to group assignment. All subjects received current standard therapy for sciatica, including: a NSAID (ibuprofen, naproxen, etodolac, or nambumetone), narcotics if needed (hydrocodone, propoxyphene, oxycodone, or morphine), activity as tolerated, and a referral for physical therapy.

Study Design

Upon entering the study all patients underwent physical exam with attention to: 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, and ability to perform five heel lifts (0-5). Patients also completed three written instruments: a “12 Item Health Status Questionnaire” (13), a “Roland-Morris Disability Questionnaire” (14), and a “Roland-Morris Pain Rating Scale” (14). Also noted at the intake visit and each subsequent visit were the number of hours each patient was working or, if they were not employed or were retired, their estimated percent of daily living activities they were able to accomplish. Lastly, note was made of whether the patient had undergone epidural steroid injection or surgical intervention since the previous visit. Each patient underwent the same exam and completed the same questionnaires weekly for four weeks post recruitment, and then monthly for five months. This led to a total of 6 months of follow-up.

All patients received non-steroidal anti-inflammatory medication and narcotic medication if needed for pain control. Patients randomized to the study group received tapering course of prednisone: 60 mg for three days, 40 mg for three days, and 20 mg for three days. Patients randomized to the control (placebo) group received capsules identical in appearance to the prednisone capsules but containing an inert filler substance. Patients were questioned at each visit to determine whether they were taking their study medication (first nine days of the study) and whether they were still taking non-steroidal or narcotic medication (entire study).

Patients were encouraged to begin non-weight-bearing aerobic activities such as swimming and/or bike riding as soon as their pain had subsided to a reasonable degree. At this point, patients generally also referred to see a physical therapist.

Patients who had rapid improvement and were under fifty generally did not have any imaging studies performed. Project staff ordered plain films of the lumbosacral spine for most patients over age 50 . Irrespective of age, patients who had intractable pain or progressive neurologic symptoms generally had plain films of the lumbosacral spine done and also underwent magnetic resonance imaging (MRI). A separate analysis of pain level ratings, narcotic and NSAID use, and return to work rates, was performed for this subgroup with the thought that they probably represented patients with the most severe nerve root inflammation and that the effects of oral prednisone might be more or less obvious in this group.

Statistical power analysis

Statistical power analysis was performed with the primary outcome of return to work within 14 days of the intervention. The proportion of the control group returning to work was hypothesized to be 50%. Oral prednisone was hypothesized to have a 50% treatment effect, resulting in a 75% rate of return to work within 14 days. Using chi square with continuity correction, statistical power analysis found that a (study and control group) sample size of 80 per subgroup would have a power of 88% to find this difference (i.e., between 50% and 75%)statistically significant at p<.05.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment




Oral Prednisone


Santa Rosa
United States




Kaiser Permanente

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:45:04-0400

Clinical Trials [489 Associated Clinical Trials listed on BioPortfolio]

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

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 b...

Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica

The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute sciatica

Study of REN-1654 in Patients With Sciatica Pain

The purpose of this study is to gain initial safety and efficacy data on the experimental agent REN-1654 in patients with pain that radiates down the leg(s), and is typical of sciatica (lu...

Physiotherapy for Sciatica; Is Earlier Better?

This study aims to evaluate the whether receiving physiotherapy early after onset of the problem is better than waiting a few weeks to see if it gets better before starting physiotherapy. ...

"The Lived Experience of Investigations for Sciatica"

This will be an exploratory study, using semi-structured interviews to explore patients' experiences of undergoing investigations for Sciatica (leg pain referred from the lower back). Inte...

PubMed Articles [3851 Associated PubMed Articles listed on BioPortfolio]

Safety and pharmacodynamic dose response of short-term prednisone in healthy adult subjects: a dose ranging, randomized, placebo-controlled, crossover study.

Glucocorticoids (GCs), such as prednisone, are the standard of care for several inflammatory and immunologically mediated diseases, but their chronic systemic administration is severely limited by ser...

Efficacy of Methylprednisolone Pulse Followed by Oral Prednisone in Birdshot Chorioretinopathy.

To report the outcomes of initial methylprednisolone pulse then oral prednisone in the treatment of birdshot chorioretinopathy (BSCR).

Non-steroidal anti-inflammatory drugs for sciatica.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most frequently prescribed drugs for the treatment of sciatica. A previous Cochrane review on the efficacy of NSAIDs summarised findings fo...

Genome-Wide Meta-Analysis of Sciatica in Finnish Population.

Sciatica or the sciatic syndrome is a common and often disabling low back disorder in the working-age population. It has a relatively high heritability but poorly understood molecular mechanisms. The ...

Introduction to the Oral and Maxillofacial Pathology focus issue on oral submucous fibrosis.

Medical and Biotech [MESH] Definitions

A condition characterized by pain radiating from the back into the buttock and posterior/lateral aspects of the leg. Sciatica may be a manifestation of SCIATIC NEUROPATHY; RADICULOPATHY (involving the SPINAL NERVE ROOTS; L4, L5, S1, or S2, often associated with INTERVERTEBRAL DISK DISPLACEMENT); or lesions of the CAUDA EQUINA.

A branch of dentistry dealing with diseases of the oral and paraoral structures and the oral management of systemic diseases. (Hall, What is Oral Medicine, Anyway? Clinical Update: National Naval Dental Center, March 1991, p7-8)

A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.

An antineoplastic agent used primarily in combination with mechlorethamine, vincristine, and prednisone (the MOPP protocol) in the treatment of Hodgkin's disease.

The practice of personal hygiene of the mouth. It includes the maintenance of oral cleanliness, tissue tone, and general preservation of oral health.

More From BioPortfolio on "The Efficacy of Oral Steroids in the Treatment of Acute Sciatica"

Quick Search

Relevant Topics

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Searches Linking to this Trial