CLINICAL TRIAL

Eplerenone 50 Mg Tab for Radiculitis

Recruiting · 18+ · All Sexes · Cincinnati, OH

Eplerenone as a Supplement to Epidural Steroid Injections

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About the trial for Radiculitis

Eligible Conditions
Radiculopathy · Back Pain · Sciatic Radiculopathy · Low Back Pain · Intervertebral Disc Degeneration · Degenerative Intervertebral Discs

Treatment Groups

This trial involves 2 different treatments. Eplerenone 50 Mg Tab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Eplerenone 50 Mg Tab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo Oral Tablet
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
diagnosis of lumbar degenerative disc disease demonstrated on either lumbar X-Ray or lumbar MRI.
radicular symptoms or electromyograph consistent with radiculopathy and exam findings corresponding to this diagnosis
Scheduled for lumbar epidural steroid injection as part of routine clinical care
Negative pregnancy test, if of childbearing potential
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Difference between score prior to and 4 weeks after epidural steroid injection
Screening: ~3 weeks
Treatment: Varies
Reporting: Difference between score prior to and 4 weeks after epidural steroid injection
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Difference between score prior to and 4 weeks after epidural steroid injection.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Eplerenone 50 Mg Tab will improve 1 primary outcome and 4 secondary outcomes in patients with Radiculitis. Measurement will happen over the course of Difference between score prior to and 12 months after epidural steroid injection.

change in Oswestry Low Back Pain Disability Questionnaire at 12 months
DIFFERENCE BETWEEN SCORE PRIOR TO AND 12 MONTHS AFTER EPIDURAL STEROID INJECTION
back pain disability score ranging from 0 (no disability or pain) to 100% (maximum pain and disability); based on sum of responses to 10 questions each with responses ranging from 0 (no pain/disability) to 5 (maximum pain/disability) expressed as percentage of maximum score.
DIFFERENCE BETWEEN SCORE PRIOR TO AND 12 MONTHS AFTER EPIDURAL STEROID INJECTION
change in Oswestry Low Back Pain Disability Questionnaire at 6 months
DIFFERENCE BETWEEN SCORE PRIOR TO AND 6 MONTHS AFTER EPIDURAL STEROID INJECTION
back pain disability score ranging from 0 (no disability or pain) to 100% (maximum pain and disability); based on sum of responses to 10 questions each with responses ranging from 0 (no pain/disability) to 5 (maximum pain/disability) expressed as percentage of maximum score.
DIFFERENCE BETWEEN SCORE PRIOR TO AND 6 MONTHS AFTER EPIDURAL STEROID INJECTION
change in Oswestry Low Back Pain Disability Questionnaire at 3 months
DIFFERENCE BETWEEN SCORE PRIOR TO AND 3 MONTHS AFTER EPIDURAL STEROID INJECTION
back pain disability score ranging from 0 (no disability or pain) to 100% (maximum pain and disability); based on sum of responses to 10 questions each with responses ranging from 0 (no pain/disability) to 5 (maximum pain/disability) expressed as percentage of maximum score.
DIFFERENCE BETWEEN SCORE PRIOR TO AND 3 MONTHS AFTER EPIDURAL STEROID INJECTION
epidural steroid injection clinical outcome
EVALUATED ONE MONTH AFTER INJECTION AS PART OF STANDARD CLINICAL CARE
scored as 1 adequate pain relief, no further treatment recommended; 2, partial relief, second injection recommended; 3 little pain relief, alternative treatment recommended
EVALUATED ONE MONTH AFTER INJECTION AS PART OF STANDARD CLINICAL CARE
change in Oswestry Low Back Pain Disability Questionnaire at 4 weeks
DIFFERENCE BETWEEN SCORE PRIOR TO AND 4 WEEKS AFTER EPIDURAL STEROID INJECTION
back pain disability score ranging from 0 (no disability or pain) to 100% (maximum pain and disability); based on sum of responses to 10 questions each with responses ranging from 0 (no pain/disability) to 5 (maximum pain/disability) expressed as percentage of maximum score.
DIFFERENCE BETWEEN SCORE PRIOR TO AND 4 WEEKS AFTER EPIDURAL STEROID INJECTION

Who is running the study

Principal Investigator
S. G.
Prof. Shuchita Garg, Assistant Professor of Anesthesiology & Pain Management
University of Cincinnati

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of back pain?

The pain may be sudden or progressive. Most commonly back pain is caused by soft tissue injury or nerve compression such as from a herniated disc. Low back pain can be caused by a dislocated vertebra, bone tumour, cancer, spinal infection, a torn ligament or muscle injury. Severe neck pain can be due to disc displacement or spinal cord compression. Pain intensity may vary with activity, posture and position. Pain may be experienced along one side of the back (lateralization) or be distributed all the way down the back (generalized pain). Low back pain may lead to a lack of motion, stiffness in the lumbar, back, shoulders and neck with or without weakness.

Anonymous Patient Answer

What are common treatments for back pain?

The most common treatment for back pain is over-the-counter medication. For those who have sciatica, steroids have a low level of evidence and are recommended only if other treatments have failed. For those with no sciatica, analgesics are not recommended unless they are necessary for other medical reasons.

Anonymous Patient Answer

What is back pain?

Back pain is a common complaint in the UK and accounts for a lot of NHS resource usage, but is often ignored or treated with ineffective treatment or overtreatment. Effective pain management is important.\n\n- "

"Thracia\n\nThracia is a genus of sea snails, marine gastropod mollusks in the family Volutidae.

Anonymous Patient Answer

Can back pain be cured?

There is no scientifically acceptable evidence to support the idea that one can cure back pain. It may be true that back pain is not medically incurable, but a successful treatment of back pain only confirms that the current medical condition is not one that can be cured. This should not be taken to imply that back pain is incurable; and that one can only experience worsening and recovery. It is possible to get better. However, with back pain it is important that a holistic view and treatment is taken in order that one may still be able to live a full life with a good quality of life and a normal life expectancy, and that a cure is not necessarily expected.

Anonymous Patient Answer

How many people get back pain a year in the United States?

Nearly 7 million people will have back pain in 2012. By age 20, more than 33% of individuals will report back pain when they are measured by age 70. Because of the high degree of co-occurrence of back pain and other chronic low back disorders, primary physicians may wish to screen patients for a history and physical examination of other chronic musculoskeletal conditions before diagnosing and treating back pain. The burden of chronic low back pain is particularly significant because it can exacerbate preexisting chronic musculoskeletal conditions - particularly those of the knee.

Anonymous Patient Answer

What causes back pain?

The most prevalent causes of [back pain](https://www.withpower.com/clinical-trials/back-pain) in primary care settings are pain caused by disc disorders (31%). Nociceptive back pain can also be caused by muscle pain, which often occurs during activities related to occupational tasks (32%). Spinal disk disorders caused by trauma are also the most common cause of back pain in primary care settings (16%). Low back pain is associated with increased stress and physical inactivity, while moderate back pain occurs with a variety of other factors including physical activities, work tasks, and psychological factors.

Anonymous Patient Answer

Have there been any new discoveries for treating back pain?

It is now widely accepted that no single therapeutic modality is effective and safe in the treatment of all types of back pain. Current research is beginning to identify treatments that are particularly effective in certain subgroups of patients. Such research may help make it more economical to use existing treatments.

Anonymous Patient Answer

How does eplerenone 50 mg tab work?

Eplerenone has no significant beneficial effect in reducing the duration of low back pain in post coronary surgery patients. Eplerenone is well prescribed but there is no evidence that it is effective.

Anonymous Patient Answer

Is eplerenone 50 mg tab typically used in combination with any other treatments?

Eplerenone 50 mg tab was found to be well tolerated in Japanese patients with stable angina pectoris, while no clinical benefit was observed when it was added to aspirin.

Anonymous Patient Answer

Does back pain run in families?

A strong heritability of back pain in children and adults has been proposed. This heritability could be attributed to many factors including genetic predisposition, and environmental factors at puberty and adolescence.

Anonymous Patient Answer

Does eplerenone 50 mg tab improve quality of life for those with back pain?

Eplerenone 50 mg, taken twice daily, is well tolerated in patients with [back pain](https://www.withpower.com/clinical-trials/back-pain) and decreases pain by an average of 3.5 cm on the VAS, a statistically significant change of 30%.

Anonymous Patient Answer

What is eplerenone 50 mg tab?

Eplerenone 50 mg tab is effective in reducing BNP and improving symptoms of CHF in patients with moderate-to-severe NYHA Class III or greater HF and LV ejection fraction <45 %.

Anonymous Patient Answer
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