Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317447
Status:
COMPLETED
Last Update Posted:
2006-04-24
First Post:
2006-04-20
Brief Title:
The Efficacy of Oral Steroids in the Treatment of Acute Sciatica
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Oral Steroids in the Treatment of Acute Sciatica A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 NSAIDs 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 weeks4 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 NSAIDs and in the need for epidural injection or surgical intervention
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 NSAIDs and in the need for epidural injection or surgical intervention
Detailed Description:
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 andor 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 ie between 50 and 75statistically significant at p05
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 andor 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 ie between 50 and 75statistically significant at p05
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None