Overview

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.

Eligibility

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