Health TrialsbyHealthPanel

Low Dose Radiotherapy for Osteoarthritis

ConditionOsteoarthitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Unable to reasonably complete study instruments.

Trial design

Design model

Single group

Treatments tested in this trial

  • Low Dose Radiation Therapy

    Radiation

    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.

Treatment groups

113 Participants
are divided into 1 treatment group
Group A: SingleOther 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

Source ClinicalTrials.gov
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