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

Официальное название

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

Обзор

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

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

• Pain during activities in thumb base joint [Срок оценки: 4 and 12 weeks]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

\- 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Норвегия · 6 центров

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

Публикации

• 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

Идентификаторы

NCT: NCT06084364 · 2023-505254-17-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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