PICASSO: Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
Study Details
Study Description
Brief Summary
A placebo-controlled randomized controlled trial exploring the effect of intraarticular steroids, saline or an occupational therapy intervention in inflammatory carpometacarpal-1 osteoarthritis
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Detailed Description
The primary aim of the PICASSO trial is to examine the efficacy and safety of intraarticular corticosteroid injections and a multimodal occupational therapy intervention in patients with CMC-1 OA (Phase 1). By comparing available non-pharmacological and pharmacological treatments head-to-head, our results will be of interest to the range of health professionals who are involved in the management of CMC-1 OA patients. By including patients who are likely to benefit from the intervention (painful and inflammatory CMC-1 OA), appropriate dosage of drug and ultrasound-guided injections, our trial is more guarded against possible false negative results than previous studies. We will also explore predictors for treatment effects. Due to the heterogeneous presentation of OA, it is unlikely that one treatment will fit all, and treatment should be tailored to the patients´ clinical presentation. Second, we will explore the long-term safety of IACS, and whether the occupational therapy intervention can prevent or halt CMC-1 subluxation (Phase 2).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Intraarticular corticosteroid injection (IACS) A single ultrasound-guided intraarticular injection of 0.50 ml of 40 mg/ml triamcinolone acetonide at baseline. A smaller dosage can be considered if there is increased resistance during injection. The same injection procedure will be repeated after 12 weeks if there is pain (NRS≥3) and inflammation (grey scale synovitis grade 1-3) present in the CMC-1 joint. |
Drug: Injection of triamcinolone acetonide into the CMC-1 joint
intraarticular injection with triamcinolone acetonide
Other Names:
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Placebo Comparator: Saline injection A single ultrasound-guided intraarticular injection of 0.50 ml of sodium chloride 9 mg/ml at baseline. A smaller dosage can be considered if there is increased resistance during injection. The same injection procedure will be repeated after 12 weeks if there is pain (NRS≥3) and inflammation (grey scale synovitis grade 1-3) present in the CMC-1 joint. |
Drug: Placebo
Intraarticular injection with saline
Other Names:
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Experimental: Occupational Therapy intervention Patient education, instructions about hand exercises and training in the Happy Hands app. Administration of day and night orthosis. The Happy Hands app involves a 12 week intervention. |
Behavioral: Multimodal Occupational therapy for CMC-1 joint OA
Patient education, instructions about hand exercises, orthosis and training
|
Outcome Measures
Primary Outcome Measures
- Thumb base joint pain [4 and 12 weeks]
Change in thumb base joint pain last 24 hours on a Numeric Rating Scale (NRS)
Secondary Outcome Measures
- Thumb base joint pain [All visits]
Change in thumb base joint pain last 24 hours on a Numeric Rating Scale (NRS)
- Finger joint pain [Week 00, 04, 12, 24, 104]
Change in finger joint pain last 24 hours on a Numeric Rating Scale (NRS)
- AUSCAN [Week 00, 04,12, 24 and 104]
Change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain, stiffness and function subscales.
- OMERACT-OARSI criteria responders [Week 00, 04, 12, 24, 104]
Number of OMERACT-OARSI criteria responders
- MAP-Hand [Week 00, 04,12, 24 and 104]
Change in measure of activity performance of the hand
- Patient-reported overall disease activity [Week 00, 04, 12, 24, 104]
Change in patient-reported overall disease activity in hands last 24 hours on a Numeric Rating Scale (NRS)
- Assessor-reported overall disease activity [Week 00, 04, 12, 24, 104]
Change in assessor-reported overall disease activity in hands on a Numeric Rating Scale (NRS)
- Pain in finger joints (hand figure) [Week 00, 04, 12, 24, 104]
Change in pain in finger joints last 24 hours (hand figure)
- Grip strength [Week 00, 04, 12, 24, 104]
Change in grip strength
- Use of analgesics [Week 00, 04, 12, 24, and 104]
Change in use of analgesics
- Use of NSAIDs [Week 00, 04, 12, 24, and 104]
Change in use of NSAIDs
- Arthritis self-efficacy scale [Week 00, 04, 12, 24, 104]
Change in arthritis self-efficacy scale
- Patient satisfaction [Week 04, 12]
Number of responders regarding patient satisfaction
- EuroQol 5 dimensions 5-levels (EQ-5D-5L) [Week 00, 04, 12, 24,104]
Change in EuroQol 5 dimensions 5-levels (EQ-5D-5L)
- Tender hand joints [Week 00, 04, 12, 24, 104]
Change in number of tender hand joints
- Swollen hand joints [Week 00, 04, 12, 24, 104]
Change in number of swollen hand joints
- Ultrasound synovitis in the CMC-1 joint [Week 00, 04,12, 24, W104]
Change in ultrasound synovitis in the CMC-1 joint
- Synovitis in the CMC-1 joint [Week 00, 04]
Change in MRI synovitis in the CMC-1 joint on contrast-enhanced MRI
- Bone marrow lesions in the CMC-1 joint [Week 00, 04]
Change in bone marrow lesions in the CMC-1 joint on contrast-enhanced MRI
- Structural progression [Week 00, 104]
Change in structural progression by Kellgren-Lawrence
- Osteophytes [Week 00, 104]
Change in osteophytes by OARSI atlas
- Joint space narrowing [Week 00, 104]
Change in joint space narrowing by OARSI atlas
- Subluxation of the CMC-1 joint [Week 00, 104]
Change in subluxation of the CMC-1 joint
- Adverse events [Week 00, 04, 12, 24, 104]
Number of adverse events
- Serious adverse events [Week 00, 04, 12, 24, 104]
Number of serious adverse events
- Withdrawals because of adverse events [Week 00, 04, 12, 24, 104]
Number of withdrawals because of adverse events
- Use of healthcare services [Week 00, 12, 24, 104]
Questions about use of healthcare services
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult (40-85 years of age) men and women
In target joint:
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OA confirmed by radiographs or ultrasound examination
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Inflammation by ultrasound (grey scale synovitis grade 1-3)
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Pain of at least 3 on a 0-10 Numeric Rating Scale (NRS) at both pre-screening and screening.
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Patient is assessed as eligible for the proposed use of Kenacort-T
Exclusion Criteria:
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Use of thumb orthosis or structured hand exercises in the last 12 weeks
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Intraarticular injections in the target CMC-1 joint in the last 12 weeks
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More than 3 previous IACS in the target CMC-1 joint
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Use of oral or intramuscular steroids in the last 12 weeks
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Previous surgery of the target CMC-1 joint
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Planned hand surgery in the coming 24 weeks
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Do not want to quit using oral or topical NSAIDs (such as ibuprofen, diclofenac, etorocoxib, naproxen) in the next 12 weeks
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Systemic inflammatory joint diseases (such as rheumatoid arthritis (RA), psoriatic arthritis or gout) or other conditions that can better explain the hand pain (such as thoracic outlet syndrome, carpal tunnel disease, diabetic cheiropathy, hand injury in previous six months, or palmar tenosynovitis/trigger finger)
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Diagnosis of fibromyalgia
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Diagnosis of psoriasis
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Infection, skin disease or wounds at joint injection site
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Serious comorbidities, cognitive dysfunction, substance/alcohol abuse or any other medical condition that makes adherence to the study protocol difficult
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Known hypersensitivity to Triamcinolone acetonide (Kenacort) or any of the excipients (sodium carboxymethylcellulose, sodium chloride, polysorbate, benzyl alcohol, sodium hydroxide or hydrochloric acid)
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Included in another clinical study
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Use of digitalis glycosides
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Patients vaccinated or immunized with live virus vaccines in the last 2 weeks
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Not being able to talk or understand Norwegian
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Known pregnancy or planned pregnancy in the next 6 months
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Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Diakonhjemmet Hospital
- Martina Hansen's Hospital
- Helse Stavanger HF
- Haugesund Rheumatism Hospital
- St. Olavs Hospital
- Nordlandssykehuset HF
Investigators
- Principal Investigator: Ida Kristin Haugen, MD, PhD, Diakonhjemmet Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-505254-17-00