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NCT05617911
Clinical Comparison of Patellofemoral Pain Syndrome Outcomes After Blood Flow Restriction Therapy
Conditions: Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome
Sex: All
Ages: 15 Years – N/A
Phase: NA
Enrollment: 96
Sponsor: Gaylord Hospital, Inc
Location: United States
Summary
The purpose of this study is to determine if Blood Flow Restriction therapy improves patient related outcomes in those diagnosed with Patellofemoral Pain Syndrome compared to those in the sham comparator control group.
Eligibility Criteria
Inclusion Criteria:Diagnosis of patellofemoral pain syndrome (PFPS) or non-specific anterior knee pain (NSAKP) and plan to attend Gaylord Specialty Healthcare Physical TherapyExclusion Criteria:Member of a defined vulnerable population, women who are or suspected to be pregnant, prisoners, children under 15, or other protected populationsBody mass of the leg preventing the cuff from fitting properlyRadiographic evidence of osteoarthritis (≥ Kellgren-Lawrence Grade 2)History of intra-articular injection into either knee within 3 -monthsUncontrolled or untreated inflammatory disorderAcute inflammatory disorderUncontrolled Diabetes and/or peripheral neuropathy, impaired circulationUncontrolled cardiac conditions including uncontrolled hypertensionAreas of thrombophlebitis, thrombosisDistal wounds or pain below the knee >4/10History of or current rhabdomyolysisProlonged immobilization (>3 months)Sickle cell anemiaLymphadenectomyVaricose veins, or a history of personal or immediate family history (parental or sibling) of deep vein thrombosisCurrent infection at or below the level of cuff placementMalignancies in or below the area to be treatedOther conditions/medications that would interfere with subject safety or data collection in the opinion of the PISubjects with an increased risk of non-response as determined by the therapistOnce entered in the study, a diagnosis change that affects participation
Source: ClinicalTrials.gov (NCT05617911). StuddyBuddy aggregates publicly available trial information.