Collecting patient feedback on low-dose radiation for osteoarthritis
Patient Reported Outcomes Following Low-dose Irradiation for Osteoarthritis (PRO-LO): A Single-arm Prospective Registry
University of North Carolina, Chapel Hill · NCT05705947
This study is trying to see how low-dose radiation therapy affects pain and quality of life for people with osteoarthritis by collecting their feedback after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05705947 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on patient-reported outcomes such as pain, function, and quality of life in individuals with osteoarthritis receiving standard radiation therapy. It is a single-institution, single-arm study that will systematically collect information to optimize radiation therapy management and clinical care. The primary focus is on changes in pain levels measured by a visual analog scale three months after treatment, alongside secondary endpoints assessing disease control and potential surgery avoidance. Participants will complete surveys to report their experiences and outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 and older with osteoarthritis in at least one joint, experiencing inadequately controlled pain despite previous treatments.
Not a fit: Patients who are pregnant, have a life expectancy of less than six months, or have shoulder osteoarthritis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of osteoarthritis through improved understanding of radiation therapy's effects on pain and function.
How similar studies have performed: While there is limited data on the specific use of low-dose radiation for osteoarthritis, similar approaches in pain management have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- UNC Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Theodore Yanagihara, MD, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Victoria Xu
- Email: victoria_xu@med.unc.edu
- Phone: 984-974-8744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoarthritis, radiation therapy