Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
- Conditions
- Osteoarthritis Thumb
- Interventions
- Behavioral: Multimodal Occupational therapy for CMC-1 joint OADrug: Placebo
- Registration Number
- NCT06084364
- Lead Sponsor
- Diakonhjemmet Hospital
- 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
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 354
- 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 rest or during activities at both pre-screening and screening.
- Patient is assessed as eligible for the proposed use of Kenacort-T
- Use of thumb orthosis on most of the days 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, etoricoxib, 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intraarticular corticosteroid injection (IACS) Injection of triamcinolone acetonide into the CMC-1 joint 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. Occupational Therapy intervention Multimodal Occupational therapy for CMC-1 joint OA 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. Saline injection Placebo 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.
- Primary Outcome Measures
Name Time Method Pain during activities in thumb base joint 4 and 12 weeks Change in thumb base joint pain during activities last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable.
- Secondary Outcome Measures
Name Time Method Use of analgesics Week 00, 04, 12, 24, and 104 Change in use of analgesics
Serious adverse events Week 00, 04, 12, 24, 104 Number of serious adverse events
Pain during activities in finger joints Week 00, 04, 12, 24, 104 Change in finger joint pain during activities last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable.
OMERACT-OARSI criteria responders Week 00, 04, 12, 24, 104 Number of OMERACT-OARSI criteria responders
Pain during activities in thumb base joint All visits Change in thumb base joint pain during activities last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable.
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 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable.
Joint space narrowing Week 00, 104 Change in joint space narrowing by OARSI atlas
Use of healthcare services Week 00, 12, 24, 104 Questions about use of healthcare services
Pain at rest in thumb base joint Week 00, 04, 12, 25, 104 Change in thumb base joint pain at rest last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable.
MAP-Hand Week 00, 04,12, 24 and 104 Change in measure of activity performance of the hand
Assessor-reported overall disease activity Week 00, 04, 12, 24, 104 Change in assessor-reported overall disease activity in hands on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable.
Pain in finger joints (hand figure) Week 00, 04, 12, 24, 104 Change in pain in finger joints last 24 hours (hand figure)
Arthritis self-efficacy scale Week 00, 04, 12, 24, 104 Change in arthritis self-efficacy scale. The response categories are 10-100 with 10 points increment between each response category. A sum score is created based on the average of the five questions. Higher scores represent better self-efficacy.
Tender hand joints Week 00, 04, 12, 24, 104 Change in number of tender hand joints
Ultrasound synovitis in the CMC-1 joint Week 00, 04,12, 24, W104 Change in ultrasound synovitis in the CMC-1 joint
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
Pain at rest in finger joints Week 00, 04, 12, 24, 104 Change in finger joint pain in rest last 24 hours on a 0-10 Numeric Rating Scale (NRS). 0 being no pain and 10 being the worst pain imaginable.
AUSCAN (Australian/Canadian hand index) Week 00, 04,12, 24 and 104 Change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain, stiffness and function subscales. Sum scores for pan (range: 0-20), stiffness (range: 0-4) and function (range: 0-36) can be calculated with higher scores representing worse health.
Grip strength Week 00, 04, 12, 24, 104 Change in grip strength
Use of NSAIDs Week 00, 04, 12, 24, and 104 Change in use of non-steroidal anti-inflammatory drugs (NSAIDs)
Osteophytes Week 00, 104 Change in osteophytes by OARSI atlas
Withdrawals because of adverse events Week 00, 04, 12, 24, 104 Number of withdrawals because of adverse events
Patient satisfaction Week 04, 12 Number of responders regarding self-reported perceived effect of treatment (yes/no). Patient satisfaction will be assessed with a question about whether the participants believe that they have had effect of the received treatment.
EuroQol 5 dimensions 5-levels (EQ-5D-5L) Week 00, 04, 12, 24,104 Change in EuroQol 5 dimensions 5-levels (EQ-5D-5L). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Swollen hand joints Week 00, 04, 12, 24, 104 Change in number of swollen hand joints
Synovitis in the CMC-1 joint Week 00, 04 Change in MRI synovitis in the CMC-1 joint on contrast-enhanced MRI
Structural progression Week 00, 104 Change in structural progression by Kellgren-Lawrence
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
Trial Locations
- Locations (6)
Nordlands Hospital
🇳🇴Bodø, Norway
Haugesund Rheumatism Hospital
🇳🇴Haugesund, Norway
Stavanger University Hospital
🇳🇴Stavanger, Norway
Diakonhjemmet Hospital
🇳🇴Oslo, Norway
Martina Hansens Hospital
🇳🇴Sandvika, Norway
St Olavs Hospital
🇳🇴Trondheim, Norway