Greater Trochanteric Pain SyndromeRENEUNCT07568015
ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain
A study testing Triamcinolone acetate and ReneuRx in people with Greater Trochanteric Pain Syndrome and Greater Trochanteric Pain Syndrome of Both Lower Limbs, run by Brixton Biosciences, Inc. at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Greater Trochanteric Pain Syndrome, Greater Trochanteric Pain Syndrome of Both Lower Limbs, Lateral Hip Pain
- What is being tested?
- Triamcinolone acetate and ReneuRx
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 11 sitesUnited States
- Study dates
- 27 Jul 2026to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Skylight Health Research
Burlington, Massachusetts, 01803
Alisha Garibaldi, 781-328-6185, alisha.garibaldi@skylighthealthresearch.com
Tom McAlindon
- Recruiting
Mass General Brigham
Chestnut Hill, Massachusetts, 02467
Kahtryn Satko, 617-732-9816, ksatko@bwh.harvard.edu
Robert Yong
- Not yet recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Jonathan Thompson, 214-645-2260, jonathan.thompson@utsouthwestern.edu
Kelechi Okoroha
- Recruiting
All-American Orthopedic & Sports
Houston, Texas, 77058
Austin Mercier, 409-904-7991, austin.mercier@elevateclinical.com
Matthew Higgs
- Not yet recruiting
Emory Orthopedics and Spine Center
Johns Creek, Georgia, 30097
Lavanya Veda, 404-778-6608, lavanya.vedanarayanan@emory.edu
Casey Wagner
- Recruiting
Rothman Orthopaedics
King of Prussia, Pennsylvania, 19406
Thema Nicholson, 267-339-3615, Thema.Nicholson@rothmanortho.com
Steve Stache
- Not yet recruiting
Ochsner Health Center
New Orleans, Louisiana, 70121
Latrell Mackey, latrell.mackey@ochsner.org
Maged Guirguis
- Not yet recruiting
Virtua Health
Sewell, New Jersey, 08080
Judith Conner, 856-325-3264, jconner@virtua.org
Sean McMillan
- Recruiting
Pain Diagnostics & Interventional Care
Sewickley, Pennsylvania, 15143
Alyssa Abrams, 412-221-7640, research@davidprovenzanomd.com
David Provenzano
- Recruiting
Healthcare Outcomes Performance Company
Sun City, Arizona, 85023
Alison Klika, 440-343-2001, alison.klika@hopco.com
John Kearney
- Recruiting
The Orthopaedic Center
Tulsa, Oklahoma, 74137
Jessica Good, 918-991-3602, jessicag@emedr.com
Yogesh Mittal
About this study
Official title: ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain: A Multi-Center, Randomized, Controlled Trial (RENEU)
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.
- Conditions
- Greater Trochanteric Pain Syndrome, Greater Trochanteric Pain Syndrome of Both Lower Limbs, Lateral Hip Pain
- Being tested
- Triamcinolone acetate, ReneuRx
- Keywords
- RENEU, ReneuRx™, ReneuRx, GTPS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetateDrug
A single 40mg Triamcinolone dose, prepared as 1ml of steroid mixed with 4ml of saline, of which 3-5ml is injected.
ReneuRxDevice
ReneuRx will be injected around the trochanteric branches of the femoral nerve.
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone acetate | Active comparator | Corticosteroid injection Receives: Drug: Triamcinolone acetate |
| ReneuRx | Experimental | Not described Receives: Device: ReneuRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ≥30% based on the NRS scale at 3 months post treatment
Measured: 3-months post treatment
Primary Safety
Aggregate serious device-related adverse events through final follow-up visit
Measured: Through study completion, an average of 12-months
Secondary outcomes (5)
Secondary Effectiveness
Numeric Rating Scales - The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. With 0 being no pain and 10 being the most pain.
Measured: Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
Secondary Effectiveness
Patient Global Impressions Scale (PGIC) The Patient Global Impression of Change (PGIC) score is a self-reported measure used to assess a patient's perception of their overall improvement or worsening in health status following a specific treatment. It is often used in clinical trials and research studies to gauge the efficacy of interventions from the patient's perspective. The PGIC typically ranges from "very much worse" to "very much improved".
Measured: 3 month and 6 month post-treatment
Secondary Effectiveness
VISA-G (Victorian Institute of Sports Assessment-Gluteal Score) The Victorian Institute of Sport Assessment (VISA-) Gluteal (G) Questionnaire is a self-report clinical outcome measure used in patients with greater trochanteric pain syndrome (GTPS). It consists of eight questions that measure the domains of pain, function in daily living, and sports activities The VISA-G can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention.
Measured: Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
Secondary Effectiveness
Change in Timed-Up and Go (TUG) test scores
Measured: 12 months post-treatment
Pain Relief
Onset of pain relief defined as time in days to pain reduced by 30% based on NRS score from baseline.
Measured: 6-Month, 12-Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start27 Jul 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Greater Trochanteric Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brixton Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568015
- Sponsor's protocol ID
- BTX-786-GTPS-02
- Acronym
- RENEU
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain: A Multi-Center, Randomized, Controlled Trial (RENEU)
- ClinicalTrials.gov ID
- NCT07568015
- Acronym / sponsor ID
- RENEU / BTX-786-GTPS-02
- Conditions
- Greater Trochanteric Pain Syndrome, Greater Trochanteric Pain Syndrome of Both Lower Limbs, Lateral Hip Pain
- Keywords
- RENEU, ReneuRx™, ReneuRx, GTPS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brixton Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone acetate | Active comparator | Drug: Triamcinolone acetateCorticosteroid injection |
| ReneuRx | Experimental | Device: ReneuRx |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone acetateA single 40mg Triamcinolone dose, prepared as 1ml of steroid mixed with 4ml of saline, of which 3-5ml is injected. | Drug | Triamcinolone acetate |
| ReneuRxReneuRx will be injected around the trochanteric branches of the femoral nerve. | Device | ReneuRx |
Primary outcome
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
5 secondary outcomes
Secondary Effectiveness
Time frame: Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
Secondary Effectiveness
Time frame: 3 month and 6 month post-treatment
Secondary Effectiveness
Time frame: Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
Secondary Effectiveness
Time frame: 12 months post-treatment
Pain Relief
Time frame: 6-Month, 12-Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Related trials for Greater Trochanteric Pain Syndrome
Recruiting
Enhancing Exercise Adherence Among Patients With Lateral Hip Pain
Greater Trochanter Pain Syndrome, Hip Pain
Not yet recruiting
Comparing Standard Care Approaches for Greater Trochanteric Pain Syndrome in General Practice
Greater Trochanteric Pain Syndrome, Gluteal Tendinopathy
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Recruiting
HILT in Greater Trochanteric Pain Syndrome
Greater Trochanteric Pain Syndrome
Recruiting
Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)
Greater Trochanteric Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone acetate and ReneuRx in people with Greater Trochanteric Pain Syndrome and Greater Trochanteric Pain Syndrome of Both Lower Limbs, run by Brixton Biosciences, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Curd (314-480-2244, david.curd@brixtonbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness (time frame: 3-months post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.