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

Phase 4RecruitingNCT06084364

Diakonhjemmet Hospital354 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

354

Conditions

Osteoarthritis Thumb

Interventions

Injection of triamcinolone acetonide into the CMC-1 jointDRUG

intraarticular injection with triamcinolone acetonide

Multimodal Occupational therapy for CMC-1 joint OABEHAVIORAL

Patient education, instructions about hand exercises, orthosis and training

PlaceboDRUG

Intraarticular injection with saline

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (6)

Nordlands Hospital

Bodø, Norway

RECRUITING

Haugesund Rheumatism Hospital

Haugesund, Norway

RECRUITING

Diakonhjemmet Hospital

Oslo, Norway

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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

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

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

Central Contacts

Ida Kristin Haugen, MD, PhD

CONTACT

+4795859884 Ida.Haugen@diakonsyk.no

Marthe Gløersen, MD

CONTACT

+4748109310 Marthe.Gloersen@diakonsyk.no

Data from ClinicalTrials.gov

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