ReneuRx for lateral hip pain: a treatment option for people with GTPS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares the safety and pain-relief performance of the ReneuRx device to corticosteroid injections in adults aged 22 to 80 with chronic lateral hip pain due to greater trochanteric pain syndrome. Participants will attend study visits, complete quality of life and outcome questionnaires, and be followed for about 6 to 12 months after the procedure. Eligibility requires persistent lateral hip pain (NRS > 5) despite prior conservative treatments and tenderness in the peritrochanteric region. Exclusion criteria include known allergies to materials used in the treatment and specific medical histories that may complicate participation. Lead sponsor is Brixton Biosciences, with collaborators and multiple clinical sites participating in the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 22 to 80, inclusive of any gender
2. 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
3. Tenderness to palpation of the peritrochanteric space of the lateral hip in adults with Greater Trochanteric Pain Syndrome.
4. 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
5. Agree to see study investigator and study team for hip pain during the study period
6. Willing/able to understand the informed consent form and provide written informed consent
7. Able to complete outcome measures (including electronic patient reported outcome measures)

Exclusion Criteria:

1. Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline
2. History of cryoglobulinemia
3. History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
4. History of cold urticaria
5. History of Chilblain's (pernio) disease in the lower extremities
6. History of Raynaud's disease
7. Open and/or infected wounds or active tumor at or near the treatment site
8. History of vascular surgery involving femoral vessels on theinjection side
9. History of hip surgery of any kind to the index side within the past 6 months (e.g., arthroscopy, arthroplasty, etc.)
10. History of trochanteric osteotomy, femoral osteotomy, amputation, or pseudoarthrosis.
11. Active bacterial or fungal infection that, at the discretion of the investigator, would preclude study participation
12. Currently taking \>60 MME/day
13. History of systemic inflammatory conditions such as rheumatoid arthritis
14. Bleeding disorders, unless appropriately stopped or reversed for the procedure at investigator's discretion
15. Any neuropathic pain condition (e.g. - complex regional pain syndrome, lumbar radiculopathy) in the area of pain
16. Presence of unstable psychiatric disease
17. Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index hip(s) within the past 12 months
18. 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
19. Known contraindication to use of a regional anesthetic block
20. Pregnant, nursing, or intent of becoming pregnant during the study period
21. Documented evidence of an overlapping pain pattern from another source that the Investigator believes to be indistinguishable from lateral hip pain
22. Lumbar or sacroiliac fusion within the previous 6 months
23. 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
24. Body habitus/hip anatomy that would preclude the use of the product injection needle size
25. Participation in any clinical study of a therapeutic investigational product within 30 days prior to enrollment
26. Pending litigation or disability status
27. Unwilling to refrain from any scheduled surgeries that would impact the collection of study endpoint data during the duration of the study
28. Subject is a prisoner

Where it's running

• Healthcare Outcomes Performance Company
  Sun City, Arizona, United States Recruiting
• Skylight Health Research
  Burlington, Massachusetts, United States Recruiting
• Mass General Brigham
  Chestnut Hill, Massachusetts, United States Recruiting
• The Orthopaedic Center
  Tulsa, Oklahoma, United States Recruiting
• Rothman Orthopaedics
  King of Prussia, Pennsylvania, United States Recruiting
• Pain Diagnostics & Interventional Care
  Sewickley, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: David Curd
• Email: david.curd@brixtonbio.com
• Phone: 314-480-2244

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• High-Intensity Laser Therapy for Greater Trochanteric Pain Syndrome

  This trial tests whether high-intensity laser therapy can reduce pain and improve function for adults with GTPS compared with a sham treatment.

  Recruiting Ankara Etlik City Hospital · Ankara, Yenimahalle · NCT07749066

• ESWT versus conventional physical therapy for Greater Trochanteric Pain Syndrome

  This trial will try Extracorporeal Shockwave Therapy (ESWT) against usual physical therapy to see which reduces pain and improves function in adults with Greater Trochanteric Pain Syndrome.

  Recruiting Kanuni Sultan Suleyman Training and Research Hospital · Istanbul · NCT07243327

• Exercise and education program for lateral hip pain

  This study is testing whether a special exercise program and education can help people with lateral hip pain feel better after 12 weeks of treatment.

  Recruiting Horsens Hospital · Horsens, Horsens · NCT06418217

• Evaluating TENEX for hip pain relief

  This study is testing if a special ultrasound-guided procedure called TENEX can help people with chronic hip pain feel better and move easier when other treatments haven't worked.

  Recruiting Montefiore Medical Center · The Bronx, New York · NCT05710627

• Improve how people with GTPS do their hip exercises by timing and reminders

  This study tests a timing-based approach, with or without reminders, to help adults with GTPS stick to a hip exercise program.

  Recruiting Loughborough University · Leicester, Leictershaire · NCT07597343

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.