[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07715188":3,"trial-entities:NCT07715188":107,"trial-summary:NCT07715188":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":68,"locations":71,"central_contacts":101,"overall_officials":104,"references":105,"see_also_links":106},"NCT07715188","UPCC 02025","Low Dose Radiotherapy for Osteoarthritis","A Prospective Study of Low Dose Radiotherapy for Osteoarthritis","RECRUITING","2029-06","2026-07","2026-07-20","2026-06-24","Abramson Cancer Center at Penn Medicine","OTHER",false,"This single institution, multi-site, single arm prospective study will enroll patients with a history of OA and assess changes in pain and function after treatment with LDRT as measured by patient-reported outcomes.","To evaluate the use of select instruments (BPI-SF, LEFS, UEFI, PROMIS Global) to detect changes in pain, function, and well-being in patients with OA who are refractory to or otherwise unable to receive other standard of care therapies.",[19],"Osteoarthitis",[21,22],"Low Dose Radiotherapy","Osteoarthritis","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},113,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"RADIATION","Low Dose Radiation Therapy","Participants will complete study intervention which consists of the BPI-SF, PROMIS Global v1.2, UEFI (for those with joint pain of the upper extremity) and\u002For LEFS (for those joint pain of the lower extremity) at baseline, 3-month and 1-year follow-up following 1 or 2 courses of standard of care LDRT.",[36],"Single",[38],{"measure":39,"description":40,"timeFrame":41},"To measure the percentage of subjects who experience a best response of 1 point or more on BPI-SF","Assess the degree of patient-reported pain prior to and after use of 1-2 courses of LDRT","Within 1 year",[43,46,50,53],{"measure":39,"description":44,"timeFrame":45},"Assess the degree of patient-reported pain prior to and after 1 course of LDRT","at ~ 3 months",{"measure":47,"description":48,"timeFrame":49},"To measure change in PROMIS scores","Assess the degree of patient-reported global wellness prior to and after use of 1-2 courses of LDRT","From baseline at 3-month and 1-year follow-up",{"measure":51,"description":52,"timeFrame":49},"To measure change in LEFS scores as measured","Assess the degree of patient-reported lower extremity function prior to and after use of 1-2 courses of LDRT",{"measure":54,"description":55,"timeFrame":49},"To measure change in UEFI scores as measured","Assess the degree of patient-reported upper extremity function prior to and after use of 1-2 courses of LDRT","ALL","18 Years",null,{"inclusion":60,"exclusion":65,"raw_text":67},[61,62,63,64],"18 years or older","Diagnosis of OA \\>3 months in hips, knees, hands, shoulders, ankles or elbows.","Refractory to standard of care therapies for OA or those who are being considered for more aggressive interventional treatment such as joint replacement, but more conservative treatment is desired.","Provision of signed and dated informed consent.",[66],"Unable to reasonably complete study instruments.","Inclusion Criteria:\n\n* 18 years or older\n* Diagnosis of OA \\>3 months in hips, knees, hands, shoulders, ankles or elbows.\n* Refractory to standard of care therapies for OA or those who are being considered for more aggressive interventional treatment such as joint replacement, but more conservative treatment is desired.\n* Provision of signed and dated informed consent.\n\nExclusion Criteria:\n\n* Unable to reasonably complete study instruments.",[69,70],"ADULT","OLDER_ADULT",[72,94],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":91},"Penn Presbyterian Medical Center","Philadelphia","Pennsylvania","19104","United States",[79,84,88],{"name":80,"role":81,"phone":82,"email":83},"Marlowe Estioko, BS, MS","CONTACT","267-343-6483","Marlowe.Estioko@Pennmedicine.upenn.edu",{"name":85,"role":81,"phone":86,"email":87},"Sonya George, BS","267-760-7636","Sonya.George@PennMedicine.upenn.edu",{"name":89,"role":90},"John Plastaras, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":92,"lon":93},39.95238,-75.16362,{"facility":95,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":96,"geoPoint":100},"Perelman Center for Advanced Medicine",[97,98,99],{"name":80,"role":81,"phone":82,"email":83},{"name":85,"role":81,"phone":86,"email":87},{"name":89,"role":90},{"lat":92,"lon":93},[102,103],{"name":80,"role":81,"phone":82,"email":83},{"name":85,"role":81,"phone":86,"email":87},[],[],[],{"nct_id":4,"conditions":108,"biomarkers":109},[22],[],{"nct_id":4,"found":111,"summary":112,"prompt_version":121},true,{"design":113,"status":114,"heading":6,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This is a single-arm study, meaning all participants receive the same intervention, and plans to enroll 113 people. It is a single institution, multi-site study.","completed","This study is testing Low Dose Radiation Therapy (LDRT) for people with osteoarthritis (OA) in joints like hips, knees, hands, shoulders, ankles, or elbows. You might be able to join if you are 18 or older, have had OA for over 3 months, and your current treatments haven't worked well, or you're considering more aggressive options like joint replacement but prefer a less invasive approach. The study aims to see if LDRT can reduce pain by measuring changes in your pain levels. The current status of this study is unclear, but it plans to enroll 113 participants.","Participants will be followed for up to 1 year after treatment.",97,"You will complete questionnaires (BPI-SF, PROMIS Global v1.2, UEFI, and\u002For LEFS) at the start, and again at 3 months and 1 year after receiving 1 or 2 courses of standard care.","Not stated in the trial record.",[33],"v2"]