Clinical trial NCT06084364: Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
Official title: Painful Inflammatory Carpometacarpal-1 Osteoarthritis Treated With Intraarticular Steroids, Saline or an Occupational Therapy Intervention: the PICASSO Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Osteoarthritis Thumb
Keywords: 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
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: Martina Hansen's Hospital
name: Helse Stavanger HF
name: Haugesund Rheumatism Hospital
name: St. Olavs Hospital
name: Nordlandssykehuset HF
First posted: 2023-10-16
Enrollment: 354
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Pain during activities in thumb base joint
timeFrame: 4 and 12 weeks
Secondary outcomes:
measure: Pain during activities in thumb base joint
timeFrame: All visits
measure: Pain at rest in thumb base joint
timeFrame: Week 00, 04, 12, 25, 104
measure: Pain during activities in finger joints
timeFrame: Week 00, 04, 12, 24, 104
measure: Pain at rest in finger joints
timeFrame: Week 00, 04, 12, 24, 104
measure: AUSCAN (Australian/Canadian hand index)
timeFrame: Week 00, 04,12, 24 and 104
measure: OMERACT-OARSI criteria responders
timeFrame: Week 00, 04, 12, 24, 104
measure: MAP-Hand
timeFrame: Week 00, 04,12, 24 and 104
measure: Patient-reported overall disease activity
timeFrame: Week 00, 04, 12, 24, 104
measure: Assessor-reported overall disease activity
timeFrame: Week 00, 04, 12, 24, 104
measure: Pain in finger joints (hand figure)
timeFrame: Week 00, 04, 12, 24, 104
measure: Grip strength
timeFrame: Week 00, 04, 12, 24, 104
measure: Use of analgesics
timeFrame: Week 00, 04, 12, 24, and 104
measure: Use of NSAIDs
timeFrame: Week 00, 04, 12, 24, and 104
measure: Arthritis self-efficacy scale
timeFrame: Week 00, 04, 12, 24, 104
measure: Patient satisfaction
timeFrame: Week 04, 12
measure: EuroQol 5 dimensions 5-levels (EQ-5D-5L)
timeFrame: Week 00, 04, 12, 24,104
measure: Tender hand joints
timeFrame: Week 00, 04, 12, 24, 104
measure: Swollen hand joints
timeFrame: Week 00, 04, 12, 24, 104
measure: Ultrasound synovitis in the CMC-1 joint
timeFrame: Week 00, 04,12, 24, W104
measure: Synovitis in the CMC-1 joint
timeFrame: Week 00, 04
measure: Bone marrow lesions in the CMC-1 joint
timeFrame: Week 00, 04
measure: Structural progression
timeFrame: Week 00, 104
measure: Osteophytes
timeFrame: Week 00, 104
measure: Joint space narrowing
timeFrame: Week 00, 104
measure: Subluxation of the CMC-1 joint
timeFrame: Week 00, 104
measure: Adverse events
timeFrame: Week 00, 04, 12, 24, 104
measure: Serious adverse events
timeFrame: Week 00, 04, 12, 24, 104
measure: Withdrawals because of adverse events
timeFrame: Week 00, 04, 12, 24, 104
measure: Use of healthcare services
timeFrame: Week 00, 12, 24, 104
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Nordlands Hospital
city: Haugesund
country: Norway
facility: Haugesund Rheumatism Hospital
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
city: Sandvika
country: Norway
facility: Martina Hansens Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Ida Kristin Haugen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Martina Hansens Hospital
name: Marte Ingeborg Sæther
role: PRINCIPAL_INVESTIGATOR
affiliation: Haugesund Rheumatism Hospital
name: Elisabet Esperø
role: PRINCIPAL_INVESTIGATOR
affiliation: Helse Stavanger HF
name: Katrine Brække Norheim
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Olavs Hospital
name: Mari Hoff
role: PRINCIPAL_INVESTIGATOR
affiliation: Nordland Hospital
name: Göran Karlsson
role: PRINCIPAL_INVESTIGATOR
References: