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Osteoarthritis ThumbPhase 4PICASSONCT06084364

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

A Phase 4 study testing Injection of triamcinolone acetonide into the CMC-1 joint and Multimodal Occupational therapy for CMC-1 joint OA in people with Osteoarthritis Thumb, run by Diakonhjemmet Hospital at 6 sites in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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 Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Osteoarthritis Thumb
What is being tested?
Injection of triamcinolone acetonide into the CMC-1 joint and Multimodal Occupational therapy for CMC-1 joint OA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
354 participants
Where
6 sitesNorway
Study dates
3 Nov 2023to Nov 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Norway6 sites

  • Nordlands Hospital

    Bodø

  • Haugesund Rheumatism Hospital

    Haugesund

  • Diakonhjemmet Hospital

    Oslo

  • Martina Hansens Hospital

    Sandvika

  • Stavanger University Hospital

    Stavanger

  • St Olavs Hospital

    Trondheim

Other trials in Norway

About this study

Official title: 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

Read the 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).

Being tested
Injection of triamcinolone acetonide into the CMC-1 joint, Multimodal Occupational therapy for CMC-1 joint OA, Placebo
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
Medical subject headings
Pain, Inflammation, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injection of triamcinolone acetonide into the CMC-1 jointDrug

    Also called Kenacort-T 40 mg/ml

    intraarticular injection with triamcinolone acetonide

  • Multimodal Occupational therapy for CMC-1 joint OABehavioural

    Patient education, instructions about hand exercises, orthosis and training

  • PlaceboDrug

    Also called Sodium chloride 9 mg/ml

    Intraarticular injection with saline

Study groups in NCT06084364
Study groupRoleWhat they receive
Intraarticular corticosteroid injection (IACS)ExperimentalA 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.
Receives: Drug: Injection of triamcinolone acetonide into the CMC-1 joint
Saline injectionPlacebo comparatorA 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.
Receives: Drug: Placebo
Occupational Therapy interventionExperimentalPatient 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.
Receives: Behavioral: Multimodal Occupational therapy for CMC-1 joint OA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 and 12 weeks

Secondary outcomes (29)

  1. 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.

    Measured: All visits

  2. 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.

    Measured: Week 00, 04, 12, 24, 104

  3. 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.

    Measured: Week 00, 04, 12, 24, 104

  4. 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.

    Measured: Week 00, 04, 12, 24, 104

  5. AUSCAN (Australian/Canadian hand index)

    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.

    Measured: Week 00, 04,12, 24 and 104

  6. OMERACT-OARSI criteria responders

    Number of OMERACT-OARSI criteria responders

    Measured: Week 00, 04, 12, 24, 104

  7. MAP-Hand

    Change in measure of activity performance of the hand

    Measured: Week 00, 04,12, 24 and 104

  8. 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 disease activity and 10 being the worst disease activity imaginable.

    Measured: Week 00, 04, 12, 24, 104

  9. 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 disease activity and 10 being the worst disease activity imaginable.

    Measured: Week 00, 04, 12, 24, 104

  10. Pain in finger joints (hand figure)

    Change in pain in finger joints last 24 hours (hand figure)

    Measured: Week 00, 04, 12, 24, 104

  11. Grip strength

    Change in grip strength

    Measured: Week 00, 04, 12, 24, 104

  12. Use of analgesics

    Change in use of analgesics

    Measured: Week 00, 04, 12, 24, and 104

  13. Use of NSAIDs

    Change in use of non-steroidal anti-inflammatory drugs (NSAIDs)

    Measured: Week 00, 04, 12, 24, and 104

  14. 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.

    Measured: Week 00, 04, 12, 24, 104

  15. 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.

    Measured: Week 04, 12

  16. 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. 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.

    Measured: Week 00, 04, 12, 24,104

  17. Tender hand joints

    Change in number of tender hand joints

    Measured: Week 00, 04, 12, 24, 104

  18. Swollen hand joints

    Change in number of swollen hand joints

    Measured: Week 00, 04, 12, 24, 104

  19. Ultrasound synovitis in the CMC-1 joint

    Change in ultrasound synovitis in the CMC-1 joint

    Measured: Week 00, 04,12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.

  20. Synovitis in the CMC-1 joint

    Change in MRI synovitis in the CMC-1 joint on contrast-enhanced MRI

    Measured: Week 00, 04

  21. Bone marrow lesions in the CMC-1 joint

    Change in bone marrow lesions in the CMC-1 joint on contrast-enhanced MRI

    Measured: Week 00, 04

  22. Structural progression

    Change in structural progression by Kellgren-Lawrence

    Measured: Week 00, 104

  23. Osteophytes

    Change in osteophytes by OARSI atlas

    Measured: Week 00, 104

  24. Joint space narrowing

    Change in joint space narrowing by OARSI atlas

    Measured: Week 00, 104

  25. Subluxation of the CMC-1 joint

    Change in subluxation of the CMC-1 joint

    Measured: Week 00, 104

  26. Adverse events

    Number of adverse events

    Measured: Week 00, 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.

  27. Serious adverse events

    Number of serious adverse events

    Measured: Week 00, 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.

  28. Withdrawals because of adverse events

    Number of withdrawals because of adverse events

    Measured: Week 04, 12, 24, 104. Will also be assessed in relation to additional injections in Phase 2.

  29. Use of healthcare services

    Questions about use of healthcare services

    Measured: Week 00, 12, 24, 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2023
  2. Study start3 Nov 2023
  3. Primary completionFeb 2027 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
354 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06084364
Sponsor's protocol ID
2023-505254-17-00
Other IDs
2023
Acronym
PICASSO
Status last verified
Oct 2026
First submitted
11 Oct 2023
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gloersen M, Kjeken I, Tveter AT, Kazemi A, Sexton J, Dziedzic K, Felson DT, Stamm TA, Guermazi A, Hermann-Eriksen M, Saether MI, Lundby K, Espero EL, Olsen M, Norheim KB, Fister EB, Hoff M, Uleberg JK, Midtgard IP, Andreassen T, Sjolie D, Sletten H, Hammer HB, Haugen IK; PICASSO study team. Study protocol for the PICASSO trial: A randomized placebo-controlled trial to investigate the efficacy and safety of intraarticular steroid injections and an occupational therapy intervention in painful inflammatory carpometacarpal-1 osteoarthritis. Osteoarthr Cartil Open. 2024 Nov 19;7(1):100542. doi: 10.1016/j.ocarto.2024.100542. eCollection 2025 Mar.

    PubMed 39669005

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Injection of triamcinolone acetonide into the CMC-1 joint and Multimodal Occupational therapy for CMC-1 joint OA in people with Osteoarthritis Thumb, run by Diakonhjemmet Hospital at 6 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain during activities in thumb base joint (time frame: 4 and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06084364, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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