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NCT07568015 · Brixton Biosciences, Inc.

ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain

(RENEU)

What this study is about

The goal of this clinical trial is to evaluate the safety and analgesic performance of the ReneuRx™ device in subjects with moderate to severe chronic lateral hip pain compared to subjects receiving treatment with corticosteroid injection in adults aged 22-80 years. Participants will attend study visits and complete quality of life questionnaires.

View original scientific description

The goal of this clinical trial is to evaluate the safety and analgesic performance of the ReneuRx™ device in subjects with moderate to severe chronic lateral hip pain compared to subjects receiving treatment with corticosteroid injection in adults aged 22-80 years. Participants will attend study visits and complete quality of life questionnaires. Participants will be followed for approximately 6-12 months after the study procedure.

Interventions

DRUG

Triamcinolone acetate

A single 40mg Triamcinolone dose, prepared as 1ml of steroid mixed with 4ml of saline, of which 3-5ml is injected.

DEVICE

ReneuRx

ReneuRx will be injected around the trochanteric branches of the femoral nerve.

Primary outcome measures

Primary Effectiveness

Time frame: 3-months post treatment

The primary endpoint of this study is the proportion of subjects whose hip pain following activity (Timed Up and Go test) is reduced by ≥30% based on the NRS scale at 3 months post treatment

Primary Safety

Time frame: Through study completion, an average of 12-months

Aggregate serious device-related adverse events through final follow-up visit

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Age 22 to 80, inclusive of any gender
  • Baseline pain intensity of \>5 of the Numeric Rating Scale (NRS) localized to the lateral aspect of the hip (with or without radiation to lateral thigh or buttock) despite current treatment
  • Tenderness to palpation of the peritrochanteric space of the lateral hip in adults with Greater Trochanteric Pain Syndrome.
  • At least 6 months of previous conservative treatments for subject's lateral hip pain (NSAID, acetaminophen, physical therapy, and/or cortisone injections) that are not currently providing relief
  • Agree to see study investigator and study team for hip pain during the study period
  • Willing/able to understand the informed consent form and provide written informed consent
  • Able to complete outcome measures (including electronic patient reported outcome measures)

Exclusion criteria

  • Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline
  • History of cryoglobulinemia
  • History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
  • History of cold urticaria
  • History of Chilblain's (pernio) disease in the lower extremities
  • History of Raynaud's disease
  • Open and/or infected wounds or active tumor at or near the treatment site
  • History of vascular surgery involving femoral vessels on theinjection side
  • History of hip surgery of any kind to the index side within the past 6 months (e.g., arthroscopy, arthroplasty, etc.)
  • History of trochanteric osteotomy, femoral osteotomy, amputation, or pseudoarthrosis.
  • Active bacterial or fungal infection that, at the discretion of the investigator, would preclude study participation
  • Currently taking \>60 MME/day
  • History of systemic inflammatory conditions such as rheumatoid arthritis
  • Bleeding disorders, unless appropriately stopped or reversed for the procedure at investigator's discretion
  • Any neuropathic pain condition (e.g. - complex regional pain syndrome, lumbar radiculopathy) in the area of pain
  • Presence of unstable psychiatric disease
  • Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index hip(s) within the past 12 months
  • Corticosteroid injection within the previous 3 months or orthobiologic therapy such as platelet rich plasma injections, or shockwave therapy for the index hip(s) within the previous 6 months
  • Known contraindication to use of a regional anesthetic block
  • Pregnant, nursing, or intent of becoming pregnant during the study period
  • Documented evidence of an overlapping pain pattern from another source that the Investigator believes to be indistinguishable from lateral hip pain
  • Lumbar or sacroiliac fusion within the previous 6 months
  • Any other condition (such as history of deep vein thrombosis, significant cardiovascular, renal failure/dialysis, hepatic or other systemic comorbidity/chronic pain condition including cancer) or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data
  • Body habitus/hip anatomy that would preclude the use of the product injection needle size
  • Participation in any clinical study of a therapeutic investigational product within 30 days prior to enrollment
  • Pending litigation or disability status
  • Unwilling to refrain from any scheduled surgeries that would impact the collection of study endpoint data during the duration of the study
  • Subject is a prisoner

Where

  • Sun City, Arizona
  • Johns Creek, Georgia
  • New Orleans, Louisiana
  • Burlington, Massachusetts
  • Chestnut Hill, Massachusetts
  • Sewell, New Jersey
  • Tulsa, Oklahoma
  • King of Prussia, Pennsylvania
  • Sewickley, Pennsylvania
  • Dallas, Texas
  • Houston, Texas

Collaborators

MCRA

Related conditions & keywords

Greater Trochanteric Pain SyndromeGreater Trochanteric Pain Syndrome of Both Lower LimbsLateral Hip PainRENEUReneuRx™ReneuRxGTPS

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Aug 4, 2026 · Source of record for eligibility and locations

📊
1 of 100 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

NOT_YET_RECRUITING

Sun City

Arizona

Location available
NOT_YET_RECRUITING

Johns Creek

Georgia

Location available
NOT_YET_RECRUITING

New Orleans

Louisiana

Location available
NOT_YET_RECRUITING

Burlington

Massachusetts

Location available
NOT_YET_RECRUITING

Chestnut Hill

Massachusetts

Location available
NOT_YET_RECRUITING

Sewell

New Jersey

Location available
NOT_YET_RECRUITING

Tulsa

Oklahoma

Location available
View Tulsa location page
NOT_YET_RECRUITING

King of Prussia

Pennsylvania

Location available
NOT_YET_RECRUITING

Sewickley

Pennsylvania

Location available

And 2 more locations available.

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Chronic Pain Trials by City

Browse all chronic pain clinical trials in these cities — not just this study.

Looking for Greater Trochanteric Pain Syndrome Treatment in Sun City?

Join others in Arizona exploring innovative treatment options through clinical research

Greater Trochanteric Pain Syndrome Treatment Options in Sun City, Arizona

If you're searching for Greater Trochanteric Pain Syndrome treatment in Sun City, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Sun City, Johns Creek, New Orleans and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Greater Trochanteric Pain Syndrome. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 100 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Greater Trochanteric Pain Syndrome?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Greater Trochanteric Pain Syndrome

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Greater Trochanteric Pain Syndrome Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07568015. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.