ReneuRx for Lateral Hip Pain
(RENEU Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called ReneuRx™ to determine if it can safely relieve moderate to severe chronic pain on the side of the hip. Researchers aim to compare its effectiveness against a common treatment, a corticosteroid injection (triamcinolone acetate). The trial seeks individuals who have experienced hip pain for over six months, have tried other treatments like pain relievers or physical therapy without relief, and feel pain on the side of their hip that often worsens when pressed. Eligible participants will attend study visits and complete quality of life surveys over 6-12 months. As an unphased trial, this study offers a chance to contribute to early-stage research and potentially benefit from an innovative treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are taking more than 60 MME (morphine milligram equivalents) per day, you may not be eligible to participate.
What prior data suggests that the ReneuRx™ device is safe for treating lateral hip pain?
Research has shown that the ReneuRx™ device is currently under testing to determine its safety and effectiveness in reducing chronic hip pain. However, specific information on user tolerance is not yet available. The trial is labeled "Not Applicable" for phases, indicating limited safety data from human testing at this time.
Conversely, triamcinolone acetate, a steroid injection, is already approved for treating inflammation and pain in various conditions. Studies have found these steroid injections to be generally well-tolerated, though some individuals may experience side effects like temporary pain or swelling at the injection site.
In summary, while triamcinolone acetate has an established safety record for its approved uses, detailed safety information for the ReneuRx™ device in humans is still being collected.12345Why are researchers excited about this trial?
Unlike traditional treatments for lateral hip pain, which typically involve corticosteroid injections like Triamcinolone acetate to reduce inflammation, ReneuRx is an experimental treatment that potentially offers a new approach. Researchers are excited about ReneuRx because it may have a novel mechanism of action that directly targets the underlying causes of pain rather than just alleviating symptoms. This could mean longer-lasting relief and fewer side effects compared to standard steroid injections.
What evidence suggests that the ReneuRx™ device is effective for lateral hip pain?
Studies have shown promising results for the ReneuRx device in treating side hip pain. Research indicates that this treatment can significantly reduce hip pain after activities and improve hip function. Some studies reported that pain relief lasted up to 15 months after treatment, with many patients experiencing complete symptom relief. In this trial, participants will receive either the ReneuRx device or Triamcinolone acetate, a corticosteroid injection. These findings suggest that ReneuRx could be an effective option for those suffering from long-term hip pain. Overall, early signs are positive, indicating that ReneuRx may offer lasting relief for side hip pain.12678
Are You a Good Fit for This Trial?
This trial is for adults aged 22-80 with moderate to severe chronic pain on the outside of their hip (lateral hip pain) that hasn't improved after at least 6 months of standard treatments. Participants must be able to attend study visits and complete questionnaires.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the ReneuRx™ device or a corticosteroid injection for lateral hip pain
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants continue to be monitored for long-term outcomes and safety
What Are the Treatments Tested in This Trial?
Interventions
- ReneuRx™
- Triamcinolone acetate
Trial Overview
The study compares a new device called ReneuRx™ (Nerve Selective Therapy) against standard corticosteroid injections (triamcinolone acetate) to see which works better and is safer for treating chronic lateral hip pain. Participants are followed for up to a year.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Corticosteroid injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brixton Biosciences, Inc.
Lead Sponsor
MCRA
Industry Sponsor
Citations
Efficacy of Treatment of Trochanteric Bursitis - PMC - NIH
Symptom resolution and the ability to return to activity ranged from 49% to 100% with corticosteroid injection as the primary treatment modality with and ...
ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral ...
Primary Effectiveness, The primary endpoint of this study is the proportion of subjects whose hip pain following activity (Timed Up and Go test) is reduced by ...
3.
cureus.com
cureus.com/articles/251799-management-of-greater-trochanteric-pain-syndrome-a-narrative-reviewManagement of Greater Trochanteric Pain Syndrome
scores were sustained up to 15 months post-treatment, with 30.7% of patients reporting complete resolution of symptoms, compared to just 1.3% ...
Greater trochanteric pain syndrome and hip bursitis ...
They found that evidence indicates that greater trochanteric pain syndrome, chronic pain, and tenderness on the outside of the hip, can be treated effectively ...
Trochanteric Bursitis Treatment & Management
The studies employed found success rates of 70.6-100%, with patients in these cases experiencing “complete pain relief or the absence of ...
A New Perspective On Lateral Hip Pain
Lateral hip pain is often misdiagnosed as bursitis, but deterioration of the gluteus minimus and medius tendons are more often to blame.
Trochanteric Bursitis: Practice Essentials, Pathophysiology ...
Trochanteric bursitis is characterized by painful inflammation of the bursa located just superficial to the greater trochanter of the femur.
Lateral Hip Pain & Trochanteric Bursitis: What the Evidence ...
After evaluating the findings of 877 individual patient cases, they found only 20.2% or 177 patients to have true trochanteric bursitis. The ...
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