100 Participants NeededMy employer runs this trial

ReneuRx for Lateral Hip Pain

(RENEU Trial)

Recruiting at 10 trial locations
DC
Overseen ByDavid Curd
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brixton Biosciences, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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

Agree to see study investigator and study team for hip pain during the study period
I am able to complete electronic health surveys and questionnaires.
I am between 22 and 80 years old.
See 4 more

Exclusion Criteria

I have had Chilblain's disease in my legs or feet.
History of cold urticaria
Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline
See 25 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the ReneuRx™ device or a corticosteroid injection for lateral hip pain

3 months
Multiple visits for treatment and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6-12 months
Regular follow-up visits

Long-term follow-up

Participants continue to be monitored for long-term outcomes and safety

12 months post-treatment

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

Group I: ReneuRxExperimental Treatment1 Intervention
Group II: Triamcinolone acetateActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brixton Biosciences, Inc.

Lead Sponsor

Trials
1
Recruited
260+

MCRA

Industry Sponsor

Trials
40
Recruited
11,100+

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 ...

Management 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 ...