Low Dose Radiotherapy for Osteoarthritis

Abramson Cancer Center at Penn Medicine113 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

113

Conditions

Osteoarthitis

Interventions

Low Dose Radiation TherapyRADIATION

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/or 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * Unable to reasonably complete study instruments.

Locations (2)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

RECRUITING

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Within 1 year

Secondary Outcomes

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 1 course of LDRT

Time frame: at ~ 3 months

To measure change in the Patient-Reported Outcomes Measurement Information System (PROMIS) scores

Assess the degree of patient-reported global wellness prior to and after use of 1-2 courses of LDR.

Time frame: From baseline at 3-month and 1-year follow-up

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

Time frame: From baseline at 3-month and 1-year follow-up

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

Time frame: From baseline at 3-month and 1-year follow-up

Central Contacts

Marlowe Estioko, BS, MS

CONTACT

267-343-6483 Marlowe.Estioko@Pennmedicine.upenn.edu

Sonya George, BS

CONTACT

267-760-7636 Sonya.George@PennMedicine.upenn.edu

Data from ClinicalTrials.gov

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