PROs Following Low-dose Irradiation for Osteoarthritis

NCT ID: NCT05705947

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2030-12-31

Brief Summary

The goal of this observational registry study is to collect data related to patient reported outcomes (pain, function, quality of life, toxicity) in osteoarthritis (OA) patients receiving standard of care radiation therapy (RT).

Detailed Description

This is a single-institution, single-arm, prospective, observational study of patients with osteoarthritis who are being treated with standard of care radiation therapy (RT). The purpose of this non-interventional study is to systematically collect data related to patient reported outcomes (pain, function, quality of life, toxicity) with the goal of optimizing approaches to management with radiation therapy and clinical care during follow up. The primary endpoint of this study is a change in visual analog pain scale (VAPS) at 3 months post radiation and a variety of secondary endpoints are aimed at assessing disease control, patient function, avoidance of invasive surgery, and toxicity. Participants will complete patient-reported outcome surveys for pain and joint-specific functional assessment.

Conditions

Osteoarthritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with osteoarthritis receiving radiation treatment

Patients with osteoarthritis receiving standard of care radiation treatment at UNC Radiation Oncology clinic. Radiation dose and fractionation prescription is at the physician's discretion.

Typically, this prescription is delivered in 6 fractions, every other day, over 2 weeks.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Willing and able to provide informed consent
• Established diagnosis of OA of at least 1 joint
• Inadequately controlled pain due to OA despite attempts with 2 or more other treatment modalities and Visual Analogue Pain Score of 4 or greater.
• Will undergo radiation as part of their standard of care for OA.
• At least 55 years old
• Ability to read and speak English.

Exclusion Criteria

• Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine ß-HCG results, obtained within 2 weeks of CT simulation for radiation planning, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses).
• Estimated life expectancy less than 6 months.
• Radiation treatment for shoulder OA
• Patient weight greater than 550lbs

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore Yanagihara, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

22-3256

Identifier Type: -

Identifier Source: org_study_id