Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis

Study Overview
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Brief Summary
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A placebo-controlled randomized controlled trial exploring the effect of intraarticular steroids, saline or an occupational therapy intervention in inflammatory carpometacarpal-1 osteoarthritis

Detailed Description
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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).

Official Title
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Painful Inflammatory Carpometacarpal-1 Osteoarthritis Treated With Intraarticular Steroids, Saline or an Occupational Therapy Intervention: the PICASSO Trial.

Conditions
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Osteoarthritis Thumb

Intervention / Treatment
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* Drug: Injection of triamcinolone acetonide into the CMC-1 joint
* Behavioral: Multimodal Occupational therapy for CMC-1 joint OA
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Adult (40-85 years of age) men and women In target joint: OA confirmed by radiographs or ultrasound examination Inflammation by ultrasound (grey scale synovitis grade 1-3) Pain of at least 3 on a 0-10 Numeric Rating Scale (NRS) at both pre-screening and screening. Patient is assessed as eligible for the proposed use of Kenacort-T Exclusion Criteria: Use of thumb orthosis or structured hand exercises in the last 12 weeks Intraarticular injections in the target CMC-1 joint in the last 12 weeks More than 3 previous IACS in the target CMC-1 joint Use of oral or intramuscular steroids in the last 12 weeks Previous surgery of the target CMC-1 joint Planned hand surgery in the coming 24 weeks Do not want to quit using oral or topical NSAIDs (such as ibuprofen, diclofenac, etorocoxib, naproxen) in the next 12 weeks 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) Diagnosis of fibromyalgia Diagnosis of psoriasis Infection, skin disease or wounds at joint injection site Serious comorbidities, cognitive dysfunction, substance/alcohol abuse or any other medical condition that makes adherence to the study protocol difficult Known hypersensitivity to Triamcinolone acetonide (Kenacort) or any of the excipients (sodium carboxymethylcellulose, sodium chloride, polysorbate, benzyl alcohol, sodium hydroxide or hydrochloric acid) Included in another clinical study Use of digitalis glycosides Patients vaccinated or immunized with live virus vaccines in the last 2 weeks Not being able to talk or understand Norwegian Known pregnancy or planned pregnancy in the next 6 months Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraarticular corticosteroid injection (IACS)<br>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<br>* intraarticular injection with triamcinolone acetonide<br>* Other names: Kenacort-T 40 mg/ml;|
| Placebo Comparator: Saline injection<br>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<br>* Intraarticular injection with saline<br>* Other names: Sodium chloride 9 mg/ml;|
| Experimental: Occupational Therapy intervention<br>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<br>* Patient education, instructions about hand exercises, orthosis and training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thumb base joint pain | Change in thumb base joint pain last 24 hours on a Numeric Rating Scale (NRS) | 4 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thumb base joint pain | Change in thumb base joint pain last 24 hours on a Numeric Rating Scale (NRS) | All visits | 
| Finger joint pain | Change in finger joint pain last 24 hours on a Numeric Rating Scale (NRS) | Week 00, 04, 12, 24, 104 | 
| AUSCAN | Change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain, stiffness and function subscales. | Week 00, 04,12, 24 and 104 | 
| OMERACT-OARSI criteria responders | Number of OMERACT-OARSI criteria responders | Week 00, 04, 12, 24, 104 | 
| MAP-Hand | Change in measure of activity performance of the hand | Week 00, 04,12, 24 and 104 | 
| Patient-reported overall disease activity | Change in patient-reported overall disease activity in hands last 24 hours on a Numeric Rating Scale (NRS) | Week 00, 04, 12, 24, 104 | 
| Assessor-reported overall disease activity | Change in assessor-reported overall disease activity in hands on a Numeric Rating Scale (NRS) | Week 00, 04, 12, 24, 104 | 
| Pain in finger joints (hand figure) | Change in pain in finger joints last 24 hours (hand figure) | Week 00, 04, 12, 24, 104 | 
| Grip strength | Change in grip strength | Week 00, 04, 12, 24, 104 | 
| Use of analgesics | Change in use of analgesics | Week 00, 04, 12, 24, and 104 | 
| Use of NSAIDs | Change in use of NSAIDs | Week 00, 04, 12, 24, and 104 | 
| Arthritis self-efficacy scale | Change in arthritis self-efficacy scale | Week 00, 04, 12, 24, 104 | 
| Patient satisfaction | Number of responders regarding patient satisfaction | Week 04, 12 | 
| EuroQol 5 dimensions 5-levels (EQ-5D-5L) | Change in EuroQol 5 dimensions 5-levels (EQ-5D-5L) | Week 00, 04, 12, 24,104 | 
| Tender hand joints | Change in number of tender hand joints | Week 00, 04, 12, 24, 104 | 
| Swollen hand joints | Change in number of swollen hand joints | Week 00, 04, 12, 24, 104 | 
| Ultrasound synovitis in the CMC-1 joint | Change in ultrasound synovitis in the CMC-1 joint | Week 00, 04,12, 24, W104 | 
| Synovitis in the CMC-1 joint | Change in MRI synovitis in the CMC-1 joint on contrast-enhanced MRI | Week 00, 04 | 
| Bone marrow lesions in the CMC-1 joint | Change in bone marrow lesions in the CMC-1 joint on contrast-enhanced MRI | Week 00, 04 | 
| Structural progression | Change in structural progression by Kellgren-Lawrence | Week 00, 104 | 
| Osteophytes | Change in osteophytes by OARSI atlas | Week 00, 104 | 
| Joint space narrowing | Change in joint space narrowing by OARSI atlas | Week 00, 104 | 
| Subluxation of the CMC-1 joint | Change in subluxation of the CMC-1 joint | Week 00, 104 | 
| Adverse events | Number of adverse events | Week 00, 04, 12, 24, 104 | 
| Serious adverse events | Number of serious adverse events | Week 00, 04, 12, 24, 104 | 
| Withdrawals because of adverse events | Number of withdrawals because of adverse events | Week 00, 04, 12, 24, 104 | 
| Use of healthcare services | Questions about use of healthcare services | Week 00, 12, 24, 104 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thumb, pain, inflammation, steroids, RCT, Occupational Therapy, Carpometacarpal-1, HappyHands, CMC-1, Picasso, intraarticular corticosteroid injections, IACS injections, thumb base pain, triamcinolone acetonide, Kenacort-T, osteoarthritis, OA