Menu
Recruiting NCT06084364

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

Phase IV Interventional Osteoarthritis Thumb

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Injection of triamcinolone acetonide into the CMC-1 joint, Multimodal Occupational therapy for CMC-1 joint OA, Placebo.
Who it may be relevant to
Registry conditions: Osteoarthritis Thumb. Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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).

Interventions

  • Drug Injection of triamcinolone acetonide into the CMC-1 joint
    intraarticular injection with triamcinolone acetonide
  • Behavioral Multimodal Occupational therapy for CMC-1 joint OA
    Patient education, instructions about hand exercises, orthosis and training
  • Drug Placebo
    Intraarticular injection with saline

Primary outcome measures

  • Pain during activities in thumb base joint [Time frame: 4 and 12 weeks]
Secondary outcome measures (12)
  • Pain during activities in thumb base joint [Time frame: All visits]
  • Pain at rest in thumb base joint [Time frame: Week 00, 04, 12, 24, 104]
  • Pain during activities in finger joints [Time frame: Week 00, 04, 12, 24, 104]
  • Pain at rest in finger joints [Time frame: Week 00, 04, 12, 24, 104]
  • AUSCAN (Australian/Canadian hand index) [Time frame: Week 00, 04,12, 24 and 104]
  • OMERACT-OARSI criteria responders [Time frame: Week 00, 04, 12, 24, 104]
  • MAP-Hand [Time frame: Week 00, 04,12, 24 and 104]
  • Patient-reported overall disease activity [Time frame: Week 00, 04, 12, 24, 104]
  • Assessor-reported overall disease activity [Time frame: Week 00, 04, 12, 24, 104]
  • Pain in finger joints (hand figure) [Time frame: Week 00, 04, 12, 24, 104]
  • Grip strength [Time frame: Week 00, 04, 12, 24, 104]
  • Use of analgesics [Time frame: Week 00, 04, 12, 24, and 104]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Norway · 6 centers
  • Nordlands Hospital — Bodø
  • Haugesund Rheumatism Hospital — Haugesund
  • Diakonhjemmet Hospital — Oslo
  • Martina Hansens Hospital — Sandvika
  • Stavanger University Hospital — Stavanger
  • St Olavs Hospital — Trondheim

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 PMID 39669005

Identifiers

NCT: NCT06084364 · 2023-505254-17-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗