Osteoarthitis
Conditions
Keywords
Low Dose Radiotherapy, Osteoarthritis
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONLow 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/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.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure the percentage of subjects who experience a best response of 1 point or more on BPI-SF | Within 1 year | Assess the degree of patient-reported pain prior to and after use of 1-2 courses of LDRT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To measure the percentage of subjects who experience a best response of 1 point or more on BPI-SF | at ~ 3 months | Assess the degree of patient-reported pain prior to and after 1 course of LDRT |
| To measure change in PROMIS scores | From baseline at 3-month and 1-year follow-up | Assess the degree of patient-reported global wellness prior to and after use of 1-2 courses of LDRT |
| To measure change in LEFS scores as measured | From baseline at 3-month and 1-year follow-up | Assess the degree of patient-reported lower extremity function prior to and after use of 1-2 courses of LDRT |
| To measure change in UEFI scores as measured | From baseline at 3-month and 1-year follow-up | Assess the degree of patient-reported upper extremity function prior to and after use of 1-2 courses of LDRT |
Countries
United States
Contacts
CONTACTMarlowe Estioko, BS, MS
CONTACTSonya George, BS
Outcome results
None listed