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NCT Number: NCT05705947

PROs Following Low-dose Irradiation for Osteoarthritis

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Chapel Hill

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Visual Analog Pain Scale (VAPS) Score Over Time

    Time frame: Baseline up to 5 years post RT

    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.

  2. Change in Hip Joint-Specific Outcome Over Time

    Time frame: Baseline up to 5 years post RT

    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.

  3. Change in Knee Joint-Specific Outcome Over Time

    Time frame: Baseline up to 5 years post RT

    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.

  4. Change in Arm, Shoulder and Hand Joint-Specific Outcome Over Time

    Time frame: Baseline up to 5 years post RT

    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.

  5. Change in Foot Joint-Specific Outcome Over Time

    Time frame: Baseline up to 5 years post RT

    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.

  6. Change in NSAID Dosage

    Time frame: Baseline up to 5 years post RT

    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.

  7. Change in Opioid Dosage

    Time frame: Baseline up to 5 years post RT

    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.

  8. Change in NSAID Frequency

    Time frame: Baseline up to 5 years post RT

    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.

  9. Change in Opioid Frequency

    Time frame: Baseline up to 5 years post RT

    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.

  10. Invasive Procedures

    Time frame: Up to 5 years post RT

    The investigator will report invasive procedures to treat the radiated joint experienced by each subject for the treatment of OA.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Patient Reported Outcomes Following Low-dose Irradiation for Osteoarthritis (PRO-LO): A Single-arm Prospective Registry

Acronym: PRO-LO

Important dates

Study start
2023
Primary completion
2025
Study completion
2030
First posted
Jan 31, 2023
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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