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

February 6, 2026 updated by: Ida Kristin Haugen, Diakonhjemmet Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
354

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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
        • Active, not recruiting
        • Martina Hansens Hospital
      • Stavanger, Norway
        • Recruiting
        • Stavanger University Hospital
        • Contact:
          • Katrine Brække Norheim
      • Trondheim, Norway
        • Recruiting
        • St Olavs Hospital
        • Contact:
          • Mari Hoff

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 CMC-1 joint:

  • OA confirmed by radiographs or ultrasound examination, and
  • Inflammation by ultrasound (grey scale synovitis grade 1-3), and
  • 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, intramuscular or intravenous 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 on the hands (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
  • Severe or uncontrolled infections
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain during activities in thumb base joint
Time Frame: 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.
4 and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
OMERACT-OARSI criteria responders
Time Frame: Week 00, 04, 12, 24, 104
Number of OMERACT-OARSI criteria responders
Week 00, 04, 12, 24, 104
MAP-Hand
Time Frame: Week 00, 04,12, 24 and 104
Change in measure of activity performance of the hand
Week 00, 04,12, 24 and 104
Pain in finger joints (hand figure)
Time Frame: Week 00, 04, 12, 24, 104
Change in pain in finger joints last 24 hours (hand figure)
Week 00, 04, 12, 24, 104
Grip strength
Time Frame: Week 00, 04, 12, 24, 104
Change in grip strength
Week 00, 04, 12, 24, 104
Use of analgesics
Time Frame: Week 00, 04, 12, 24, and 104
Change in use of analgesics
Week 00, 04, 12, 24, and 104
Tender hand joints
Time Frame: Week 00, 04, 12, 24, 104
Change in number of tender hand joints
Week 00, 04, 12, 24, 104
Swollen hand joints
Time Frame: Week 00, 04, 12, 24, 104
Change in number of swollen hand joints
Week 00, 04, 12, 24, 104
Synovitis in the CMC-1 joint
Time Frame: Week 00, 04
Change in MRI synovitis in the CMC-1 joint on contrast-enhanced MRI
Week 00, 04
Bone marrow lesions in the CMC-1 joint
Time Frame: Week 00, 04
Change in bone marrow lesions in the CMC-1 joint on contrast-enhanced MRI
Week 00, 04
Structural progression
Time Frame: Week 00, 104
Change in structural progression by Kellgren-Lawrence
Week 00, 104
Osteophytes
Time Frame: Week 00, 104
Change in osteophytes by OARSI atlas
Week 00, 104
Joint space narrowing
Time Frame: Week 00, 104
Change in joint space narrowing by OARSI atlas
Week 00, 104
Subluxation of the CMC-1 joint
Time Frame: Week 00, 104
Change in subluxation of the CMC-1 joint
Week 00, 104
Use of healthcare services
Time Frame: Week 00, 12, 24, 104
Questions about use of healthcare services
Week 00, 12, 24, 104
Pain during activities in thumb base joint
Time Frame: 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.
All visits
Pain during activities in finger joints
Time Frame: 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.
Week 00, 04, 12, 24, 104
Pain at rest in finger joints
Time Frame: 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.
Week 00, 04, 12, 24, 104
Use of NSAIDs
Time Frame: Week 00, 04, 12, 24, and 104
Change in use of non-steroidal anti-inflammatory drugs (NSAIDs)
Week 00, 04, 12, 24, and 104
Arthritis self-efficacy scale
Time Frame: 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.
Week 00, 04, 12, 24, 104
Patient satisfaction
Time Frame: 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.
Week 04, 12
Pain at rest in thumb base joint
Time Frame: Week 00, 04, 12, 24, 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.
Week 00, 04, 12, 24, 104
AUSCAN (Australian/Canadian hand index)
Time Frame: Week 00, 04,12, 24 and 104
Change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain, stiffness and function subscales. Sum scores for pain (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
Time Frame: 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 disease activity and 10 being the worst disease activity imaginable.
Week 00, 04, 12, 24, 104
Assessor-reported overall disease activity
Time Frame: 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 disease activity and 10 being the worst disease activity imaginable.
Week 00, 04, 12, 24, 104
EuroQol 5 dimensions 5-levels (EQ-5D-5L)
Time Frame: 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. On the EQ-VAS the participant is instructed to self-rate their health on a 0-100 scale, where 0=worst health and 100=best health.
Week 00, 04, 12, 24,104
Ultrasound synovitis in the CMC-1 joint
Time Frame: Week 00, 04,12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.
Change in ultrasound synovitis in the CMC-1 joint
Week 00, 04,12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.
Adverse events
Time Frame: Week 00, 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.
Number of adverse events
Week 00, 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.
Serious adverse events
Time Frame: Week 00, 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.
Number of serious adverse events
Week 00, 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.
Withdrawals because of adverse events
Time Frame: Week 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.
Number of withdrawals because of adverse events
Week 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Diakonhjemmet Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vestre Viken Hospital Trust
Helse Stavanger HF
St. Olavs Hospital
Nordlandssykehuset HF
Haugesund Rheumatism Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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