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

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

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

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis Thumb
• Intervention / Treatment: Drug: Injection of triamcinolone acetonide into the CMC-1 joint; Drug: Placebo; Behavioral: Multimodal Occupational therapy for CMC-1 joint OA

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 Type: Interventional
• Enrollment (Estimated): 354
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ida Kristin Haugen, MD, PhD; Phone Number: +4795859884; Email: Ida.Haugen@diakonsyk.no
• Study Contact Backup: Name: Marthe Gløersen, MD; Phone Number: +4748109310; Email: Marthe.Gloersen@diakonsyk.no

Study Locations

• Norway
  • Bodø, Norway
    • Recruiting
    • Nordlands Hospital
    • Contact: Göran Karlsson
  • Haugesund, Norway
    • Recruiting
    • Haugesund Rheumatism Hospital
    • Contact: Elisabet Esperø
  • Oslo, Norway
    • Recruiting
    • Diakonhjemmet Hospital
    • Contact: Ida Kristin Haugen
  • Sandvika, Norway
    • Recruiting
    • Martina Hansens Hospital
    • Contact: Marte Ingeborg Sæther
  • Stavanger, Norway
    • Recruiting
    • Stavanger University Hospital
    • Contact: Katrine Brække Norheim
  • Trondheim, Norway
    • Recruiting
    • St Olavs Hospital
    • Contact: Mari Hoff

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
Use of NSAIDs	Change in use of non-steroidal anti-inflammatory drugs (NSAIDs)	Week 00, 04, 12, 24, and 104
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
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
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

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Collaborators: Helse Stavanger HF; St. Olavs Hospital; Nordlandssykehuset HF; Haugesund Rheumatism Hospital; Martina Hansen's Hospital
• Investigators: Study Director: Ida Kristin Haugen, MD, PhD, Diakonhjemmet Hospital; Principal Investigator: Marte Ingeborg Sæther, Martina Hansens Hospital; Principal Investigator: Elisabet Esperø, Haugesund Rheumatism Hospital; Principal Investigator: Katrine Brække Norheim, Helse Stavanger HF; Principal Investigator: Mari Hoff, St. Olavs Hospital; Principal Investigator: Göran Karlsson, Nordland Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: osteoarthritis; pain; Occupational Therapy; RCT; inflammation; steroids; OA; triamcinolone acetonide; thumb; Carpometacarpal-1; HappyHands; CMC-1; Picasso; intraarticular corticosteroid injections; IACS injections; thumb base pain; Kenacort-T
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 2023-505254-17-00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No