Radiotherapy Compared to Corticosteroid Injection for Treatment of Hand Osteoarthritis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorMayo Clinic
About this trial
The purpose of this research is to compare low-dose radiotherapy to corticosteroid injection for treatment of hand/wrist osteoarthritis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Corticosteroid injection (CSI)
DrugA 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)
RadiationSubjects 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.
Treatment groups
165 Participants
are divided into 2 treatment groupsGroup A: Low-dose radiotherapy (LDRT)Experimental treatment 1 intervention
Group B: Corticosteroid injection (CSI)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-interventionSecondary outcomes
1
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.
Time frame
Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention2
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.
Time frame
Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention3
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.
Time frame
6 months and 12 months post-interventionSponsors and contacts
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Source ClinicalTrials.gov