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Prednisone dosage for herniated disc
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 ESIswhich 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 randomizationparticipants 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.
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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.
❿- Prednisone dosage for herniated disc
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. PracticeUpdate is free to end users but we rely on advertising to fund our site.
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Sign in. Join now. Follow us on:. Search PracticeUpdate Cancel. A short course of steroids does not improve pain but has a modest effect on function in patients with acute radiculopathy caused by a herniated lumbar disc. Primary Care Written by. Bottom Line There are a number of primary care scenarios where the use of an intervention has been traditionally provided but has little if any benefit and may increase adverse effects ie, the use of antibiotics in the case of likely viral syndromes.
Oral steroids for acute radiculopathy due to a herniated lumbar disk: a randomized clinical trial. Adverse consequences of glucocorticoid medication: psychological, cognitive, and behavioral effects. Am J Psychiatry. This abstract is available on the publisher's site. Access this abstract now. Importance Oral steroids are commonly used to treat acute sciatica due to a herniated disk but have not been evaluated in an appropriately powered clinical trial.
Several secondary outcomes showed small but inconsistent improvements in the active treatment group relative to the placebo group. In this trial, there was no significant difference between the two groups in the likelihood of undergoing spine surgery at week follow-up. National Institutes of Health to Drs. Goldberg and Avins.
Patients in the prednisolone group showed more improvement at 3 and 52 weeks on the ODI score than the placebo group. There was no difference in pain scores or rate of surgery at 1 year between the 2 groups. The prednisolone group reported more adverse events at 3 weeks.
Sciatica is one of the most common pain conditions in primary care. The symptoms, especially if recurrent, bring up many worries for the patient: Is it a blown disc? Will I need surgery? Will I be able to get back to work? In this scenario, the treatments considered vary widely.
One of the most common tactics used in this battle is throwing the granddaddy of anti-inflammatories at the problem. Unfortunately, investigators in a recent large trial on the topic found the tactic to be less than impressive. At the beginning of the trial the researchers picked a 7-point greater reduction in disability scores Oswestry as a clinically meaningful reduction.
At 3 weeks, the disability scores were 6. There appeared to be a likelihood of a greater disability reduction in the steroid responders; but, by 52 weeks, the total difference in disability between groups was 7. Conversely, there was no difference in lower-extremity pain scores at any point in time. Additionally, the number of individuals who went on to surgery, although not statistically significant, was 18 in the steroid group vs 8 in the placebo group.
Additionally, more data are becoming available on the adverse consequences of glucocorticoid medications, including a recent analysis that found higher rates of psychological, cognitive, and behavioral adverse effects including a nearly seven times higher rate of suicide or suicide attempt.
There are a number of primary care scenarios where the use of an intervention has been traditionally provided but has little if any benefit and may increase adverse effects ie, the use of antibiotics in the case of likely viral syndromes. The current study on the use of a steroid, which provided minimal benefit in function, no benefit in pain, and an increase in adverse effects in this setting of sciatica due to disk herniation, may need to be added to this list. The traditional use of steroids in this setting needs to be carefully scrutinized and discussed with long-term patient-centered outcomes in mind.
Also, the more than double rate of proceeding to surgery, which avoidance of is often one of the rationales for pulling steroids out of the tool box, also deserves further study. The use of the ODI is helpful. Oral steroids are commonly used to treat acute sciatica due to a herniated disk but have not been evaluated in an appropriately powered clinical trial. To determine if oral prednisone is more effective than placebo in improving function and pain among patients with acute sciatica.
Randomized, double-blind, placebo-controlled clinical trial conducted from to in a large integrated health care delivery system in Northern California. Observed baseline and 3-week mean ODI scores were The prednisone-treated group showed an adjusted mean 6. Compared with the placebo group, the prednisone group showed an adjusted mean 0.
The prednisone group showed an adjusted mean 3. There were no differences in surgery rates at week follow-up. Having 1 or more adverse events at 3-week follow-up was more common in the prednisone group than in the placebo group Among patients with acute radiculopathy due to a herniated lumbar disk, a short course of oral steroids, compared with placebo, resulted in modestly improved function and no improvement in pain.
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Please update your settings with a valid address before to continue using PracticeUpdate. Close Back. Sign in. Join now. Follow us on:. Search PracticeUpdate Cancel. A short course of steroids does not improve pain but has a modest effect on function in patients with acute radiculopathy caused by a herniated lumbar disc. Primary Care Written by. Bottom Line There are a number of primary care scenarios where the use of an intervention has been traditionally provided but has little if any benefit and may increase adverse effects ie, the use of antibiotics in the case of likely viral syndromes.
Oral steroids for acute radiculopathy due to a herniated lumbar disk: a randomized clinical trial. Adverse consequences of glucocorticoid medication: psychological, cognitive, and behavioral effects.
Am J Psychiatry. This abstract is available on the publisher's site. Access this abstract now. Importance Oral steroids are commonly used to treat acute sciatica due to a herniated disk but have not been evaluated in an appropriately powered clinical trial. Objective To determine if oral prednisone is more effective than placebo in improving function and pain among patients with acute sciatica.
Design, Setting, and Participants Randomized, double-blind, placebo-controlled clinical trial conducted from to in a large integrated health care delivery system in Northern California. Results Observed baseline and 3-week mean ODI scores were Conclusions and Relevance Among patients with acute radiculopathy due to a herniated lumbar disk, a short course of oral steroids, compared with placebo, resulted in modestly improved function and no improvement in pain.
Additional Info. National Library of Medicine. Become a PracticeUpdate member now. Further Reading. Primary Care Primary Care.
The recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 to 2 days before travel to the malarious area. Participants were randomly assigned in a ratio to receive a tapering day course of oral prednisone (5 days each of 60 mg, 40 mg, and The recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 to 2 days before travel to the malarious area. ;[19]). The steroid dosing regimen consisted of mg capsules of prednisone given as 60 mg daily for 5 days, then 40 mg daily. 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. For general information, Learn About Clinical Studies.Mogil creation. Among patients with acute radiculopathy sciatica due to a herniated lumbar disk, a short course of oral steroids, compared with placebo, resulted in modest improvement in function and no significant improvement in pain, according to a study in the May 19 issue of JAMA. Many patients with sciatica endure substantial pain and disability. For those who do not recover quickly, invasive procedures such as epidural steroid injections ESIs and surgery are commonly performed.
Oral administration of steroid medication may provide similar anti-inflammatory activity, can be delivered quickly by primary care providers, carries less risk, and would be much less expensive than an ESI. Oral steroids are used by many community physicians and have been included in some clinical guidelines; however, no appropriately powered clinical trials of oral steroids for radiculopathy have been conducted to date, according to background information in the article.
Harley Goldberg, D. The researchers found a small, statistically significant improvement in function change in baseline ODI at both 3 weeks and 52 weeks favoring the prednisone-treated group but no difference in lower extremity pain scores. Several secondary outcomes showed small but inconsistent improvements in the active treatment group relative to the placebo group. In this trial, there was no significant difference between the two groups in the likelihood of undergoing spine surgery at week follow-up.
National Institutes of Health to Drs. Goldberg and Avins. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc. Our Embargo Policy Print.
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