OsteoarthritisPRO-LONCT05705947
PROs Following Low-dose Irradiation for Osteoarthritis
An observational study of Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, aged 55 or above, who are receiving radiation treatment at UNC Radiation Oncology for Osteoarthritis are the intended study population.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Reported Outcomes Following Low-dose Irradiation for Osteoarthritis (PRO-LO): A Single-arm Prospective Registry
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).
Read the 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
- Keywords
- Osteoarthritis, radiation therapy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Pain Scale (VAPS) Score from Baseline to M3 Post Radiation Treatment Completion
The investigators will use the visual analog 0-10 pain scale (VAPS) and compare the baseline pre-radiation measurement to that measured at 3 months post radiation.
Measured: Baseline and 3 months post RT
Secondary outcomes (10)
Change in Visual Analog Pain Scale (VAPS) Score Over Time
The investigators will use the visual analog 0-10 pain scale (VAPS), where 0 is no pain and 10 is the worst physical pain imaginable, and compare the baseline pre-radiation measurement to that assessed at 6 weeks, 6 and 12 months, and yearly up to 5 years post radiation (RT). Higher scores indicate a worse outcome.
Measured: Baseline up to 5 years post RT
Change in Hip Joint-Specific Outcome Over Time
Joint-specific outcomes measures scales will include the Hip Injury and Osteoarthritis Outcome Score (HOOS). With 1 being the most functional usage of the joint, and 5 being least functional usage of the joint. The higher the value, the less functional outcome of the joint. Investigators will compare the baseline pre-radiation measurement to that assessed at 6 weeks, 3, 6 and 12 months, and yearly up to 5 years post radiation.
Measured: Baseline up to 5 years post RT
Change in Knee Joint-Specific Outcome Over Time
Joint-specific outcomes measures scales will include the Knee Injury and Osteoarthritis Outcome Score (KOOS). With 1 being the most functional usage of the joint, and 5 being least functional usage of the joint. The higher the value, the less functional outcome of the joint. It will compare the baseline pre-radiation measurement to that assessed at 6 weeks, 3, 6 and 12 months, and yearly up to 5 years post radiation.
Measured: Baseline up to 5 years post RT
Change in Arm, Shoulder and Hand Joint-Specific Outcome Over Time
Joint-specific outcomes measures scales will include the Disability of Arm Shoulder and Hand (DASH). With 1 being the most functional usage of the joint, and 5 being least functional usage of the joint. The higher the value, the less functional outcome of the joint. It will compare the baseline pre-radiation measurement to that assessed at 6 weeks, 3, 6 and 12 months, and yearly up to 5 years post radiation.
Measured: Baseline up to 5 years post RT
Change in Foot Joint-Specific Outcome Over Time
Joint-specific outcomes measures scales will include the Foot \& Ankle Disability Index Score (FADI). With 1 being the most functional usage of the joint, and 5 being least functional usage of the joint. The higher the value, the less functional outcome of the joint. It will compare the baseline pre-radiation measurement to that assessed at 6 weeks, 3, 6 and 12 months, and yearly up to 5 years post radiation.
Measured: Baseline up to 5 years post RT
Change in NSAID Dosage
The investigator will compare NSAID doses at baseline to that measured at 6 weeks, 3, 6, and 12 months, and yearly up to 5 years post-radiation.
Measured: Baseline up to 5 years post RT
Change in Opioid Dosage
The investigator will compare opioid doses at baseline to that measured at 6 weeks, 3, 6, and 12 months, and yearly up to 5 years post-radiation.
Measured: Baseline up to 5 years post RT
Change in NSAID Frequency
The investigator will compare NSAID frequencies at baseline to that measured at 6 weeks, 3, 6, and 12 months, and yearly up to 5 years post radiation.
Measured: Baseline up to 5 years post RT
Change in Opioid Frequency
The investigator will compare opioid frequencies at baseline to that measured at 6 weeks, 3, 6, and 12 months, and yearly up to 5 years post radiation.
Measured: Baseline up to 5 years post RT
Invasive Procedures
The investigator will report invasive procedures to treat the radiated joint experienced by each subject for the treatment of OA.
Measured: Up to 5 years post RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start31 May 2023
- Primary completion11 Dec 2025
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theodore Yanagihara, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705947
- Sponsor's protocol ID
- 22-3256
- Acronym
- PRO-LO
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2023
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes Following Low-dose Irradiation for Osteoarthritis (PRO-LO): A Single-arm Prospective Registry
- ClinicalTrials.gov ID
- NCT05705947
- Acronym / sponsor ID
- PRO-LO / 22-3256
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, radiation therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- Dec 2030 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, aged 55 or above, who are receiving radiation treatment at UNC Radiation Oncology for Osteoarthritis are the intended study population.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Visual Analog Pain Scale (VAPS) Score from Baseline to M3 Post Radiation Treatment Completion
Time frame: Baseline and 3 months post RT
The investigators will use the visual analog 0-10 pain scale (VAPS) and compare the baseline pre-radiation measurement to that measured at 3 months post radiation.
10 secondary outcomes
Change in Visual Analog Pain Scale (VAPS) Score Over Time
Time frame: Baseline up to 5 years post RT
Change in Hip Joint-Specific Outcome Over Time
Time frame: Baseline up to 5 years post RT
Change in Knee Joint-Specific Outcome Over Time
Time frame: Baseline up to 5 years post RT
Change in Arm, Shoulder and Hand Joint-Specific Outcome Over Time
Time frame: Baseline up to 5 years post RT
Change in Foot Joint-Specific Outcome Over Time
Time frame: Baseline up to 5 years post RT
Change in NSAID Dosage
Time frame: Baseline up to 5 years post RT
Change in Opioid Dosage
Time frame: Baseline up to 5 years post RT
Change in NSAID Frequency
Time frame: Baseline up to 5 years post RT
Change in Opioid Frequency
Time frame: Baseline up to 5 years post RT
Invasive Procedures
Time frame: Up to 5 years post RT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore Yanagihara, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Pain Scale (VAPS) Score from Baseline to M3 Post Radiation Treatment Completion (time frame: Baseline and 3 months post RT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.