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Prednisone for sciatica dosage. Oral steroids in initial treatment of acute sciatica |
Steroids for sciatica | MDedge Internal Medicine.Prednisone Offers Modest Relief in Sciatica | MedPage Today
Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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 day course of prednisone capsules or a 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. 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 day course of placebo capsules. Drug: Placebo Placebo capsules will look the same as the study medication but will not contain active medicine. It is measured on a 0-to scale, with higher numbers indicating greater disability. Secondary Outcome Measures : 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 scale, with higher numbers indicating greater pain.
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 scale, with higher numbers indicating greater pain. 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, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.
Federal Government. Read our disclaimer for details. Results First Posted : April 28, Last Update Posted : April 28, View this study on Beta.
Study Description. 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. Detailed Description:. Drug Information available for: Prednisone. FDA Resources.
Arms and Interventions. 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.
Participants will receive a day course of placebo capsules. Placebo capsules will look the same as the study medication but will not contain active medicine. Outcome Measures. The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status.
Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to scale, with higher numbers indicating greater pain. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials. Oral steroids for acute radiculopathy due to a herniated lumbar disk: a randomized clinical trial. Back Pain Leg Pain. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Drug: Prednisone Drug: Placebo. Phase 2. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Triple Participant, Care Provider, Investigator. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Experimental: Prednisone Participants will receive a day tapering course of prednisone capsules.
R01AR U. April 29, Key Record Dates.
❿Prednisone for sciatica dosage.Steroids for sciatica
Prednisone for sciatica dosage
Goldberg and colleagues enrolled adults with radicular pain lasting 3 months or less, an ODI score of 30 or higher, and a herniated disc confirmed by MRI. They were randomly assigned to a tapering day course of oral prednisone or placebo from to The dosing course was 5 days each of 60 mg, 40 mg, and 20 mg, for a total cumulative dose of mg. The primary outcome was ODI change at 3 weeks.
Secondary outcomes included ODI change at 1 year and change in lower extremity pain. The observed baseline and 3-week mean ODI scores were were At 52 weeks, those in the study arm had a mean 7. In terms of pain, the prednisone group had a mean 0. The authors found no statistically significant difference between groups in changes in patients' below-waist pain rating either at 3 weeks or 52 weeks.
Over the 1-year follow-up period, there was no significant between-group difference in the likelihood of undergoing spine surgery 9. Mild adverse events included insomnia, nervousness, and increased appetite, all of which are common with prednisone therapy, the authors said. At 1 year, there were no significant differences in the proportion of participants in each group reporting at least one adverse event While there were five serious adverse events overall with three occurring in the study arm -- appendectomy, suicide attempt, and deep venous thrombosis -- none were deemed related to prednisone, Goldberg's group stated.
Study limitations included a potentially inadequate prednisone dosing schedule and partially successful blinding because of common adverse events with the oral steroid. Also, the results may be limited to patients with a positive MRI finding and a baseline ODI score of 30 points or higher.
Green agreed that the latter criteria limits the applicability of the results. The reality of back pain in primary care is much messier. In real-world practice, this treatment will get used for patients who are, and who really aren't good candidates.
So the results will be rather mixed. 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. 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 day course of placebo capsules. Drug: Placebo Placebo capsules will look the same as the study medication but will not contain active medicine. It is measured on a 0-to scale, with higher numbers indicating greater disability.
Secondary Outcome Measures : 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 scale, with higher numbers indicating greater pain. 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 scale, with higher numbers indicating greater pain.
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, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Results First Posted : April 28, Last Update Posted : April 28, View this study on Beta.
Study Description. 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. Detailed Description:. Drug Information available for: Prednisone.
FDA Resources. Arms and Interventions. 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. Participants will receive a day course of placebo capsules.
Placebo capsules will look the same as the study medication but will not contain active medicine. Outcome Measures. The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status.
Objective: Many physicians use prednisone to treat acute sciatica with the hope of speeding recovery. There is little clinical evidence to support this practice. Our objective was to determine whether early administration of oral prednisone affects parameters related to recovery from acute sciatica.
Patients and investigators were blinded to the drug administered. Follow-up assessment was done weekly for 1 month and then monthly for 5 months. Results: Prednisone and control groups showed no statistically significant differences in physical findings, use of nonsteroidal anti-inflammatory drugs or narcotic medications, or rates of patients returning to work at any time interval studied.
Compared with controls, patients who received prednisone had more rapid rates of improvement from baseline in pain, mental well-being, and disability scores.
These changes were subtle but statistically significant. Patients who received prednisone tended to receive fewer epidural injections for pain. Conclusions: Early administration of oral steroid medication in patients with acute sciatica had no significant effect on most parameters studied.
It did, however, lead to slightly more rapid rates of improvement in pain, mental well-being, and disability scores. The impact of oral steroids on other outcomes is suggested by this study, but its small sample size limited its statistical power. Abstract Objective: Many physicians use prednisone to treat acute sciatica with the hope of speeding recovery. Substances Glucocorticoids Prednisone.
Objective: Many physicians use prednisone to treat acute sciatica with the hope of speeding recovery. There is little clinical evidence to support this. The prednisone group received 20 milligrams 3 times a day for 5 days; then twice a day for 5 days; then once daily for 5 days—for a total of Oral steroids are used commonly in patients with acute lumbar radiculopathy or sciatica, but strong evidence of benefit is lacking. A total of adults with radicular pain for 3 months or less, an Oswestry Disability Index (ODI) of at least 30, and a herniated disk. 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. Study record managers: refer to the Data Element Definitions if submitting registration or results information.A short course of oral steroids moderately improved function in patients with herniated lumbar disc, but did not improve pain, according to a randomized,controlled trial. After 3 weeks of treatment with prednisone, patients experienced an adjusted mean 6. The group also reported that patients in the prednisone group more commonly had one or more adverse events at 3-week follow-up versus the placebo group This study gives us the best evidence so far about its real effects, and like so many treatments for back conditions, the effects are modest.
Lee A. It's a well done [randomized, controlled trial] and it reported on outcomes that matter. The effect was positive but modest, as the authors point out, and there were some side effects issues, though not severe. Goldberg and colleagues enrolled adults with radicular pain lasting 3 months or less, an ODI score of 30 or higher, and a herniated disc confirmed by MRI.
They were randomly assigned to a tapering day course of oral prednisone or placebo from to The dosing course was 5 days each of 60 mg, 40 mg, and 20 mg, for a total cumulative dose of mg. The primary outcome was ODI change at 3 weeks. Secondary outcomes included ODI change at 1 year and change in lower extremity pain.
The observed baseline and 3-week mean ODI scores were were At 52 weeks, those in the study arm had a mean 7. In terms of pain, the prednisone group had a mean 0. The authors found no statistically significant difference between groups in changes in patients' below-waist pain rating either at 3 weeks or 52 weeks.
Over the 1-year follow-up period, there was no significant between-group difference in the likelihood of undergoing spine surgery 9. Mild adverse events included insomnia, nervousness, and increased appetite, all of which are common with prednisone therapy, the authors said. At 1 year, there were no significant differences in the proportion of participants in each group reporting at least one adverse event While there were five serious adverse events overall with three occurring in the study arm -- appendectomy, suicide attempt, and deep venous thrombosis -- none were deemed related to prednisone, Goldberg's group stated.
Study limitations included a potentially inadequate prednisone dosing schedule and partially successful blinding because of common adverse events with the oral steroid. Also, the results may be limited to patients with a positive MRI finding and a baseline ODI score of 30 points or higher.
Green agreed that the latter criteria limits the applicability of the results. The reality of back pain in primary care is much messier.
In real-world practice, this treatment will get used for patients who are, and who really aren't good candidates. So the results will be rather mixed.
Thomas Schwenk, MD, of the University of Nevada School of Medicine in Reno commented that using oral steroids for lumbar disc pain is "an example of a widely accepted practice that has indeed not been studied well on a controlled basis, and turns out to be modest at best. Deyo said that he'd like to see a head-to-head comparison between oral prednisone and injected steroids in this patient population.
Goldberg's group pointed out that, despite conflicting evidence, epidural steroid injections are offered to patients "under the assumption that radicular symptoms are caused by inflammation of the affected lumbar nerve root. Goldberg disclosed no relevant relationships with industry. One co-author disclosed relevant relationships with the U. Source Reference: Goldberg H, et al "Oral steroids for acute radiculopathy due to a herniated lumbar disk: a randomized clinical trial" JAMA ; Share on Facebook.
Opens in a new tab or window. Share on Twitter. Share on LinkedIn. Action Points A short course of oral steroids moderately improved function but not pain in patients with acute radiculopathy due to herniated lumbar disc.
Steroid-treated patients had more adverse events compared with placebo-treated patients.
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