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

Sponsor

Diakonhjemmet Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06084364

Collaborator

Martina Hansen's Hospital (Other), Helse Stavanger HF (Other), Haugesund Rheumatism Hospital (Other), St. Olavs Hospital (Other), Nordlandssykehuset HF (Other)

354

Enrollment

Arms

Anticipated Duration (Months)

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
Osteoarthritis Thumb	Drug: Injection of triamcinolone acetonide into the CMC-1 joint Behavioral: Multimodal Occupational therapy for CMC-1 joint OA Drug: Placebo	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

Study Type:

Interventional

Anticipated Enrollment :

354 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

The participants and the occupational therapist who examine the patients are blinded for the content of the intraarticular injections. The rheumatologist who perform the intrarticular injection will not be blinded for the content.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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: Kenacort-T 40 mg/ml
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: Sodium chloride 9 mg/ml
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

Arm

Intervention/Treatment

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:

Kenacort-T 40 mg/ml

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:

Sodium chloride 9 mg/ml

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

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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