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

Osteoarthritis Thumb Clinical Trial

— PICASSO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084364
• Other study ID #: 2023-505254-17-00
• Status: Recruiting
• Phase: Phase 4
• Start date: November 3, 2023
• Est. completion date: November 2027

Study information

• Verified date: January 2024
• Source: Diakonhjemmet Hospital
• Contact: Ida Kristin Haugen, MD, PhD
• Phone: +4795859884
• Email: Ida.Haugen[@]diakonsyk.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: November 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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 rest or during activities at both pre-screening and screening.

• Patient is assessed as eligible for the proposed use of Kenacort-T

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Thumb

Intervention

Drug:
• Injection of triamcinolone acetonide into the CMC-1 joint
intraarticular injection with triamcinolone acetonide

Behavioral:
• Multimodal Occupational therapy for CMC-1 joint OA
Patient education, instructions about hand exercises, orthosis and training

Drug:
• Placebo
Intraarticular injection with saline

Locations

Country	Name	City	State
Norway	Nordlands Hospital	Bodø
Norway	Haugesund Rheumatism Hospital	Haugesund
Norway	Diakonhjemmet Hospital	Oslo
Norway	Martina Hansens Hospital	Sandvika
Norway	Stavanger University Hospital	Stavanger
Norway	St Olavs Hospital	Trondheim

Sponsors (6)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	Haugesund Rheumatism Hospital, Helse Stavanger HF, Martina Hansen's Hospital, Nordlandssykehuset HF, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during activities in thumb base joint	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.	4 and 12 weeks
Secondary	Pain during activities in thumb base joint	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.	All visits
Secondary	Pain at rest in thumb base joint	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.	Week 00, 04, 12, 25, 104
Secondary	Pain during activities in finger joints	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.	Week 00, 04, 12, 24, 104
Secondary	Pain at rest in finger joints	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.	Week 00, 04, 12, 24, 104
Secondary	AUSCAN (Australian/Canadian hand index)	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.	Week 00, 04,12, 24 and 104
Secondary	OMERACT-OARSI criteria responders	Number of OMERACT-OARSI criteria responders	Week 00, 04, 12, 24, 104
Secondary	MAP-Hand	Change in measure of activity performance of the hand	Week 00, 04,12, 24 and 104
Secondary	Patient-reported overall disease activity	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.	Week 00, 04, 12, 24, 104
Secondary	Assessor-reported overall disease activity	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.	Week 00, 04, 12, 24, 104
Secondary	Pain in finger joints (hand figure)	Change in pain in finger joints last 24 hours (hand figure)	Week 00, 04, 12, 24, 104
Secondary	Grip strength	Change in grip strength	Week 00, 04, 12, 24, 104
Secondary	Use of analgesics	Change in use of analgesics	Week 00, 04, 12, 24, and 104
Secondary	Use of NSAIDs	Change in use of non-steroidal anti-inflammatory drugs (NSAIDs)	Week 00, 04, 12, 24, and 104
Secondary	Arthritis self-efficacy scale	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.	Week 00, 04, 12, 24, 104
Secondary	Patient satisfaction	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.	Week 04, 12
Secondary	EuroQol 5 dimensions 5-levels (EQ-5D-5L)	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.	Week 00, 04, 12, 24,104
Secondary	Tender hand joints	Change in number of tender hand joints	Week 00, 04, 12, 24, 104
Secondary	Swollen hand joints	Change in number of swollen hand joints	Week 00, 04, 12, 24, 104
Secondary	Ultrasound synovitis in the CMC-1 joint	Change in ultrasound synovitis in the CMC-1 joint	Week 00, 04,12, 24, W104
Secondary	Synovitis in the CMC-1 joint	Change in MRI synovitis in the CMC-1 joint on contrast-enhanced MRI	Week 00, 04
Secondary	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
Secondary	Structural progression	Change in structural progression by Kellgren-Lawrence	Week 00, 104
Secondary	Osteophytes	Change in osteophytes by OARSI atlas	Week 00, 104
Secondary	Joint space narrowing	Change in joint space narrowing by OARSI atlas	Week 00, 104
Secondary	Subluxation of the CMC-1 joint	Change in subluxation of the CMC-1 joint	Week 00, 104
Secondary	Adverse events	Number of adverse events	Week 00, 04, 12, 24, 104
Secondary	Serious adverse events	Number of serious adverse events	Week 00, 04, 12, 24, 104
Secondary	Withdrawals because of adverse events	Number of withdrawals because of adverse events	Week 00, 04, 12, 24, 104
Secondary	Use of healthcare services	Questions about use of healthcare services	Week 00, 12, 24, 104