PROs Following Low-dose Irradiation for Osteoarthritis

NCT05705947 | Active Not Recruiting

• 1 other identifier: 22-3256
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis

Keywords

Osteoarthritis; radiation therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 3 months post RT

Secondary Outcomes (10)

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

  Baseline up to 5 years post RT

• Change in Hip Joint-Specific Outcome Over Time

  Baseline up to 5 years post RT

• Change in Knee Joint-Specific Outcome Over Time

  Baseline up to 5 years post RT

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

  Baseline up to 5 years post RT

• Change in Foot Joint-Specific Outcome Over Time

  Baseline up to 5 years post RT

Study Arms (1)

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.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients, aged 55 or above, who are receiving radiation treatment at UNC Radiation Oncology for Osteoarthritis are the intended study population.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Theodore Yanagihara, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 31, 2023
• Study Start: May 31, 2023
• Primary Completion: December 11, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)