PROs Following Low-dose Irradiation for Osteoarthritis

Osteoarthritis Clinical Trial

— PRO-LO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705947
• Other study ID #: 22-3256
• Status: Recruiting
• Start date: May 31, 2023
• Est. completion date: May 2034

Study information

• Verified date: May 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Victoria Xu
• Phone: 984-974-8744
• Email: victoria_xu[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2034
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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 60 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.

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline up to 5 years post RT
Secondary	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.	Baseline up to 5 years post RT
Secondary	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.	Baseline up to 5 years post RT
Secondary	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.	Baseline up to 5 years post RT
Secondary	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.	Baseline up to 5 years post RT
Secondary	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.	Baseline up to 5 years post RT
Secondary	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.	Baseline up to 5 years post RT
Secondary	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.	Baseline up to 5 years post RT
Secondary	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.	Baseline up to 5 years post RT
Secondary	Invasive Procedures	The investigator will report invasive procedures to treat the radiated joint experienced by each subject for the treatment of OA.	Up to 5 years post RT