NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis
ConditionThumb Osteoarthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorMayo Clinic
About this trial
The Researchers are trying to compare two different types of intraarticular injections (injection in the joint) for treating the symptoms of moderate to advanced basilar thumb arthritis. One injection is ketorolac (an NSAID) and the other is triamcinolone (a corticosteroid).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults >40 years of age
Pain at the thumb base brought on by direct pressure (grind test) and with movement
Pain resistant to previous conservative management (including over the counter medications (ibuprofen/acetaminophen), icing, splinting/braces, or topical analgesics)
Radiological observation indicative of arthritis based on the Eaton-Littler classification system (stages 1 through 4)
Disqualifiers
• Known allergy to either of the treatment products
Patient's analgesic treatment regimen or other modalities of managing symptoms/pain associated with their hand pathology was modified within four weeks before trial inclusion
Symptomatic Scaphoid-trapezial arthritis present
Localized or systemic infection
Trial design
Design model
Parallel
Treatments tested in this trial
Ketorolac
DrugIntervention will be an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).
Triamcinolone
DrugIntervention will be an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Non-steroidal anti-inflammatory drug (NSAID)Experimental treatment 1 intervention
Group B: CorticosteroidActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analogue Scale (VAS) of Pain
Patient-reported VAS score with both motion and rest of the CMC joint. The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.
Time frame
At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.Secondary outcomes
1
Michigan Hand Outcomes Questionnaire (MHQ)
The Michigan Hand Outcomes Questionnaire (MHQ) is patient-reported. An overall MHQ score can be obtained by summing the scores for all six scales after reversing the pain scale (pain=100-pain score) and then dividing by six. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.
Time frame
At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.2
Grip Strength
Grip strength measured with a dynamometer, reported in kilograms. Measurements will be performed three times, with the mean value of the three repetitions used as the reported value.
Time frame
At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.3
Apposition Strength
Apposition strength measured with a dynamometer, reported in kilograms. Measurements will be performed three times, with the mean value of the three repetitions used as the reported value.
Time frame
At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.4
Opposition Strength
Opposition strength measured with a dynamometer, reported in kilograms. Measurements will be performed three times, with the mean value of the three repetitions used as the reported value.
Time frame
At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.Sponsors and contacts
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Source ClinicalTrials.gov