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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR053960 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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 15-day course of prednisone capsules or a 15-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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone | Experimental | Participants will receive a 15-day tapering course of prednisone capsules. |
|
| Placebo | Placebo Comparator | Participants will receive a 15-day course of placebo capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index, v2 | The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability. | Baseline, Week 3 follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Numerical Rating Scale | Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain. | Baseline, Week 3 follow-up |
| Oswestry Disability Index, v2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harley Goldberg, DO | Kaiser Permanente San Jose Medical Center | Principal Investigator |
| Andrew L. Avins, MD, MPH | Kaiser Permanente Division of Research | Principal Investigator |
| William Firtch, MD | Kaiser Permanente Redwood City | Principal Investigator |
| Mark Tyburski, MD | Kaiser Permanente, Roseville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California, Redwood City | Redwood City | California | 94063 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25988461 | Derived | Goldberg H, Firtch W, Tyburski M, Pressman A, Ackerson L, Hamilton L, Smith W, Carver R, Maratukulam A, Won LA, Carragee E, Avins AL. Oral steroids for acute radiculopathy due to a herniated lumbar disk: a randomized clinical trial. JAMA. 2015 May 19;313(19):1915-23. doi: 10.1001/jama.2015.4468. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prednisone | Participants will receive a 15-day tapering course of prednisone capsules. 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. |
| FG001 | Placebo | Participants will receive a 15-day course of placebo capsules. Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary Outcome Time Point (3 Weeks) |
| |||||||||||||
| Secondary Outcome Time Point (52 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prednisone | Participants will receive a 15-day tapering course of prednisone capsules. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oswestry Disability Index, v2 | The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 3 follow-up |
|
Entire study period, up to 52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prednisone | Participants will receive a 15-day tapering course of prednisone capsules. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Partial nephrectomy | Renal and urinary disorders | Systematic Assessment | Resection of renal cell carcinoma found incidentally on study imaging |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular problem | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Avins | Kaiser Permanente, Northern California | 510-891-3557 | andy.l.avins@kp.org |
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| ID | Term |
|---|---|
| D012585 | Sciatica |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Placebo | Drug | Placebo capsules will look the same as the study medication but will not contain active medicine. |
|
The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability. |
| Baseline, Week 52 follow-up |
| Pain Numerical Rating Scale | Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain. | Baseline, Week 52 follow-up |
| Kaiser Permanente |
| Roseville |
| California |
| 95661 |
| United States |
| Kaiser Permanente Northern California, San Jose | San Jose | California | 94119 | United States |
| NOT COMPLETED |
|
| BG001 | Placebo | Participants will receive a 15-day course of placebo capsules. Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine.
|
|
| Secondary | Pain Numerical Rating Scale | Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 3 follow-up |
|
|
|
| Secondary | Oswestry Disability Index, v2 | The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 52 follow-up |
|
|
|
| Secondary | Pain Numerical Rating Scale | Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 52 follow-up |
|
|
|
| 3 |
| 181 |
| 143 |
| 181 |
| EG001 | Placebo | Participants will receive a 15-day course of placebo capsules. Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine. | 2 | 88 | 63 | 88 |
|
| Deep venous thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Upper GI bleed | Gastrointestinal disorders | Systematic Assessment |
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| Appendectomy | Gastrointestinal disorders | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | Systematic Assessment |
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| Dermatologic problem | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Ear or eye disorder | Ear and labyrinth disorders | Systematic Assessment |
|
| Gastrointestinal problem | Gastrointestinal disorders | Systematic Assessment |
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| Genitourinary problem | Renal and urinary disorders | Systematic Assessment |
|
| Neurologic problem | Nervous system disorders | Systematic Assessment |
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| Psychiatric disorder | Psychiatric disorders | Systematic Assessment |
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| Pulmonary problem | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Kidney problem | Renal and urinary disorders | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |