ClinicalTrials.gg
Active, not recruitingNCT06084364PICASSOUpdated Nov 2, 2026

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

A Phase 4 interventional study of Injection of triamcinolone acetonide into the CMC-1 joint and Multimodal Occupational therapy for CMC-1 joint OA in Osteoarthritis Thumb, sponsored by Diakonhjemmet Hospital. Active, not recruiting at 6 sites in Norway. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Diakonhjemmet Hospital · Phase 4, Interventional, and Treatment

Updated Nov 2, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
354
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • 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
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 354 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Diakonhjemmet Hospital is the lead sponsor of 62 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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 to Triamcinolone acetonide (Kenacort) or any of the (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 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
354 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugInjection of triamcinolone acetonide into the CMC-1 joint

    intraarticular injection with triamcinolone acetonide

    Also known as: Kenacort-T 40 mg/ml

  • BehavioralMultimodal Occupational therapy for CMC-1 joint OA

    Patient education, instructions about hand exercises, orthosis and training

  • DrugPlacebo

    Intraarticular injection with saline

    Also known as: Sodium chloride 9 mg/ml

06

What researchers measure

Primary outcomes

  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.

    Time frame: 4 and 12 weeks

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Week 00, 04,12, 24 and 104

  6. OMERACT-OARSI criteria responders

    Number of OMERACT-OARSI criteria responders

    Time frame: Week 00, 04, 12, 24, 104

  7. MAP-Hand

    Change in measure of activity performance of the hand

    Time frame: 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.

    Time frame: 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.

    Time frame: Week 00, 04, 12, 24, 104

  10. Pain in finger joints (hand figure)

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

    Time frame: Week 00, 04, 12, 24, 104

  11. Grip strength

    Change in grip strength

    Time frame: Week 00, 04, 12, 24, 104

  12. Use of analgesics

    Change in use of analgesics

    Time frame: Week 00, 04, 12, 24, and 104

  13. Use of NSAIDs

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Week 00, 04, 12, 24,104

  17. Tender hand joints

    Change in number of tender hand joints

    Time frame: Week 00, 04, 12, 24, 104

  18. Swollen hand joints

    Change in number of swollen hand joints

    Time frame: Week 00, 04, 12, 24, 104

  19. Ultrasound synovitis in the CMC-1 joint

    Change in 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.

  20. Synovitis in the CMC-1 joint

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

    Time frame: 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

    Time frame: Week 00, 04

  22. Structural progression

    Change in structural progression by Kellgren-Lawrence

    Time frame: Week 00, 104

  23. Osteophytes

    Change in osteophytes by OARSI atlas

    Time frame: Week 00, 104

  24. Joint space narrowing

    Change in joint space narrowing by OARSI atlas

    Time frame: Week 00, 104

  25. Subluxation of the CMC-1 joint

    Change in subluxation of the CMC-1 joint

    Time frame: Week 00, 104

  26. Adverse events

    Number of adverse events

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Week 00, 12, 24, 104

07

Study locations

6 sites
08

References and documents

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 ↗
09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Nov 2, 2026
Primary completion
Jan 2027→Feb 2027
Nov 2, 2026
Study completion
Oct 2028→Nov 2028
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Recruiting→Active, not recruiting
    Primary completion Jan 2027→Feb 2027
    Study completion Oct 2028→Nov 2028
    + 4 other changes: identifiers, verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06084364
Lead sponsor
Diakonhjemmet Hospital
Collaborators
Vestre Viken Hospital Trust, Helse Stavanger HF, Haugesund Rheumatism Hospital, St. Olavs Hospital, Nordlandssykehuset HF
Responsible party
Ida Kristin Haugen (Rheumatologist, senior researcher, Diakonhjemmet Hospital) — Principal investigator
First posted
Oct 16, 2023
Start date
Nov 3, 2023
Primary completion
Feb 2027 (estimated)
Completion
Nov 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

Ida Kristin Haugen, MD, PhD
study director · Diakonhjemmet Hospital
Marte Ingeborg Sæther
principal investigator · Martina Hansens Hospital
Elisabet Esperø
principal investigator · Haugesund Rheumatism Hospital
Katrine Brække Norheim
principal investigator · Helse Stavanger HF
Mari Hoff
principal investigator · St. Olavs Hospital
Göran Karlsson
principal investigator · Nordland Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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