Osteoarthritis HandPhase 4NCT07217405
Radiotherapy Compared to Corticosteroid Injection for Treatment of Hand Osteoarthritis
A Phase 4 study testing Corticosteroid injection (CSI) and Low-dose radiotherapy (LDRT) in people with Osteoarthritis Hand and Osteoarthritis Wrist, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to compare low-dose radiotherapy to corticosteroid injection for treatment of hand/wrist osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis Hand, Osteoarthritis Wrist
- What is being tested?
- Corticosteroid injection (CSI) and Low-dose radiotherapy (LDRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2025to 1 Oct 2027
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at Mayo Clinic, Rochester, MN
- Age 50 years or older
- Mild, moderate, or severe hand OA (Kellgren and Lawrence classification grade 2, 3, or 4) on hand radiographs within the last 24 months
- Hand OA pain with a minimum VAS score relating to hand pain of ≥40 (on a 100-point scale) when using the affected hand
- Ability to complete study questionnaires
Who cannot join
- History of previous surgery to the affected hand(s)
- Autoimmune joint disease such as rheumatoid arthritis or psoriatic arthritis
- Active confounding hand condition such as stenosing tenosynovitis or Dupuytren's contracture
- Recent injury (within last 1 month) to the affected hand causing current pain
- History of crystalline arthritis (gout or pseudogout) flare in the affected hand(s)
- Active use of opioid pain medication(s) or oral steroids within the last 3 months
Show all 12Show fewer
- Fibromyalgia or central sensitization syndrome
- Hand CSI or other hand injection within the past 3 months
- History of hand LDRT within the past 3 months
- Poorly controlled diabetes (HbA1c > 10%)
- Active infection
- Current pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Tochukwu Iyke-Nzeocha, (507) 422-3201, iyke-nzeocha.tochukwu@mayo.edu
Melissa Wang, M.A., CCRP, (507) 266-6911, wang.melissa@mayo.edu
About this study
Official title: Low-Dose Radiotherapy Compared to Corticosteroid Injection for Treatment of Hand Osteoarthritis
The purpose of this research is to compare low-dose radiotherapy to corticosteroid injection for treatment of hand/wrist osteoarthritis.
- Conditions
- Osteoarthritis Hand, Osteoarthritis Wrist
- Being tested
- Corticosteroid injection (CSI), Low-dose radiotherapy (LDRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid injection (CSI)Drug
Also called Methylprednisolone, Lidocaine
A maximum of 3 joints will be treated with standard a standard combination of methylprednisolone and lidocaine:
- 1st Carpometacarpal (CMC) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine*
- Radiocarpal (RC) joint - 40 mg methylprednisolone/1 mL 1% lidocaine*
- Scaphotrapeziotrapezoidal (STT) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine*
- Metacarpophalangeal (MCP) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine
- Interphalangeal (IP) joint - 10 mg methylprednisolone/0.25 mL 1% lidocaine
Low-dose radiotherapy (LDRT)Radiation
Subjects will be treated with low-dose radiotherapy of 300cGy in 6 fractions, 2-3 times per week on non-consecutive days.
Non-responders to the initial LDRT treatment will receive a second treatment course of 300cGy in 6 fractions to be given 2-3 times per week on non-consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose radiotherapy (LDRT) | Experimental | Subjects will receive a total of six (6) low-dose radiotherapy (LDRT) treatments for hand osteoarthritis. Receives: Radiation: Low-dose radiotherapy (LDRT) |
| Corticosteroid injection (CSI) | Active comparator | Subjects will receive standard of care corticosteroid injection (CSI) therapy for hand osteoarthritis. Receives: Drug: Corticosteroid injection (CSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) score
Pain values reported by participants will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score.
Measured: Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention
Secondary outcomes (3)
Change in Cochin Hand Function Scale scores
The Cochin Hand Function Scale (CHFS) uses an 18-item, 5-point Likert scale (0 to 5) for scoring, where higher scores indicate greater difficulty with hand function. Scores range from 0 (no difficulty) to 90 (impossible to complete) by summing the ratings for all 18 items. This scale measures the ability to perform daily activities related to the hand, such as kitchen tasks, dressing, and hygiene.
Measured: Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention
Change in analgesic medication use
Change in analgesic medication use will be assessed using the Qualitative Analgesic Questionnaire [QAC]. The QAC is a 3 question self-report survey tracking current use of pain medications.
Measured: Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention
Patient experience, as measured by Was It Worth It questionnaire
The Was It Worth It questionnaire is a 4-question survey consisting of yes/no questions regarding the treatment experience. The greater number of questions with a 'yes' response indicate a higher level of patient satisfaction.
Measured: 6 months and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start19 Dec 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis HandStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terin T. Sytsma, Mayo Clinic
- Investigators
- Terin Sytsma, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217405
- Sponsor's protocol ID
- 24-010252
- Status last verified
- Apr 2026
- First submitted
- 14 Oct 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Radiotherapy Compared to Corticosteroid Injection for Treatment of Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT07217405
- Acronym / sponsor ID
- 24-010252
- Conditions
- Osteoarthritis Hand, Osteoarthritis Wrist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 16 Oct 2025 (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 purpose of this research is to compare low-dose radiotherapy to corticosteroid injection for treatment of hand/wrist osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose radiotherapy (LDRT) | Experimental | Radiation: Low-dose radiotherapy (LDRT)Subjects will receive a total of six (6) low-dose radiotherapy (LDRT) treatments for hand osteoarthritis. |
| Corticosteroid injection (CSI) | Active comparator | Drug: Corticosteroid injection (CSI)Subjects will receive standard of care corticosteroid injection (CSI) therapy for hand osteoarthritis. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient at Mayo Clinic, Rochester, MN
- Age 50 years or older
- Mild, moderate, or severe hand OA (Kellgren and Lawrence classification grade 2, 3, or 4) on hand radiographs within the last 24 months
- Hand OA pain with a minimum VAS score relating to hand pain of ≥40 (on a 100-point scale) when using the affected hand
- Ability to complete study questionnaires
Key exclusion criteria (12 listed)
- History of previous surgery to the affected hand(s)
- Autoimmune joint disease such as rheumatoid arthritis or psoriatic arthritis
- Active confounding hand condition such as stenosing tenosynovitis or Dupuytren's contracture
- Recent injury (within last 1 month) to the affected hand causing current pain
- History of crystalline arthritis (gout or pseudogout) flare in the affected hand(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroid injection (CSI)Also: Methylprednisolone, LidocaineA maximum of 3 joints will be treated with standard a standard combination of methylprednisolone and lidocaine: * 1st Carpometacarpal (CMC) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine* * Radiocarpal (RC) joint - 40 mg methylprednisolone/1 mL 1% lidocaine* * Scaphotrapeziotrapezoidal (STT) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine* * Metacarpophalangeal (MCP) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine * Interphalangeal (IP) joint - 10 mg methylprednisolone/0.25 mL 1% lidocaine | Drug | Corticosteroid injection (CSI) |
| Low-dose radiotherapy (LDRT)Subjects will be treated with low-dose radiotherapy of 300cGy in 6 fractions, 2-3 times per week on non-consecutive days. Non-responders to the initial LDRT treatment will receive a second treatment course of 300cGy in 6 fractions to be given 2-3 times per week on non-consecutive days. | Radiation | Low-dose radiotherapy (LDRT) |
Primary outcome
Change in Visual Analog Scale (VAS) score
Time frame: Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention
Pain values reported by participants will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score.
3 secondary outcomes
Change in Cochin Hand Function Scale scores
Time frame: Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention
Change in analgesic medication use
Time frame: Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention
Patient experience, as measured by Was It Worth It questionnaire
Time frame: 6 months and 12 months post-intervention
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 24 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Terin Sytsma, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Corticosteroid injection (CSI) and Low-dose radiotherapy (LDRT) in people with Osteoarthritis Hand and Osteoarthritis Wrist, run by Mayo Clinic 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 24 Apr 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Tochukwu Iyke-Nzeocha ((507) 422-3201, Iyke-Nzeocha.Tochukwu@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) score (time frame: Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention). 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 24 Apr 2026.