NCT07715188

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
35mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jun 2029

Study Start

First participant enrolled

June 24, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

2.9 years

First QC Date

July 15, 2026

Last Update Submit

July 15, 2026

Conditions

Keywords

Low Dose RadiotherapyOsteoarthritis

Outcome Measures

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

    Within 1 year

Secondary Outcomes (4)

  • To measure the percentage of subjects who experience a best response of 1 point or more on BPI-SF

    at ~ 3 months

  • To measure change in PROMIS scores

    From baseline at 3-month and 1-year follow-up

  • To measure change in LEFS scores as measured

    From baseline at 3-month and 1-year follow-up

  • To measure change in UEFI scores as measured

    From baseline at 3-month and 1-year follow-up

Study Arms (1)

Single

OTHER

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.

Radiation: Low Dose Radiation Therapy

Interventions

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.

Single

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to reasonably complete study instruments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 20, 2026

Study Start

June 24, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations