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Tendon needling versus platelet-rich plasma in gluteal muscle inflammation: clinical trial

Tendon fenestration versus platelet rich plasma in trochanteric syndrome : a randomized clinical trial - PRP Platelet Rich Plasma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2ycrhb3
Enrollment
52
Registered
2026-02-12
Start date
2025-06-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gluteal tendinitis

Interventions

This is a prospective, randomized, controlled, double-blinded, two-arm clinical trial. Experimental group: 26 patients with a clinical diagnosis of greater trochanteric pain syndrome will receive a pl

Sponsors

Irmandade da Santa Casa de Misericórdia de São Paulo
Lead Sponsor
Irmandade da Santa Casa de Misericórdia de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged over 18 years; presence of lateral hip pain for at least 3 months refractory to conservative treatment including physiotherapy and analgesia; score greater than 5 on the visual analog scale for pain during daily activities; clinical diagnosis of greater trochanteric pain syndrome according to the physical examination cluster with tenderness on palpation of the greater trochanter and reproduction of pain with resisted hip abduction in flexion; signature of the informed consent form

Exclusion criteria

Exclusion criteria: Patients allergic to the medications used that cannot be substituted in our service; use of ciprofloxacin in the past year; prior tendon infiltration in the past year; presence of active autoimmune or rheumatologic diseases such as rheumatoid arthritis or systemic lupus erythematosus; active local or systemic infections including osteomyelitis or cellulitis in the hip region; uncontrolled diabetes mellitus with HbA1c greater than or equal to 8%; difficulty or uncertainty in returning for periodic follow-up visits; pregnancy or breastfeeding; chronic use of anticoagulants or other medications that contraindicate the proposed procedures; participation in other concurrent clinical studies that may interfere with the results; degenerative or mechanical joint changes of the hip evidenced on radiographs in the presence of clinical suspicion

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of gluteus medius tendon fenestration associated with local anesthetic injection, compared with platelet-rich plasma injection and local anesthetic, in the control of pain among patients clinically diagnosed with greater trochanteric pain syndrome. Pain intensity will be assessed using the visual analog pain scale, applied before the intervention and during follow-up (15 days, 1 month, 3 months, and 6 months). The outcome will be considered achieved when there is a minimum reduction of 2 points on the visual analog pain scale compared to baseline, a difference considered clinically meaningful and statistically significant (p = 0.05).

Secondary

MeasureTime frame
To evaluate the improvement in functionality and quality of life of patients undergoing both therapeutic methods. Functionality will be analyzed using the VISA-G questionnaire, and quality of life will be assessed with the SF-36 questionnaire, both applied before and after the intervention at the established follow-up periods (1 month, 3 months, and 6 months). The outcome will be considered achieved when there is a significant increase in VISA-G and SF-36 scores compared to baseline values, with a statistically significant difference (p = 0.05) between the groups.

Countries

Brazil

Contacts

Public ContactAndre Sau

Irmandade da Santa Casa de Misericórdia de São Paulo

grupocirurgiadoquadrildot@gmail.com+55 (11) 2176-7000

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026