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

Primary Purpose

Osteoarthritis Thumb

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Injection of triamcinolone acetonide into the CMC-1 joint
Multimodal Occupational therapy for CMC-1 joint OA
Placebo
Sponsored by
Diakonhjemmet Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Thumb focused on measuring 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

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Adult (40-85 years of age) men and women In target joint: OA confirmed by radiographs or ultrasound examination Inflammation by ultrasound (grey scale synovitis grade 1-3) Pain of at least 3 on a 0-10 Numeric Rating Scale (NRS) at both pre-screening and screening. Patient is assessed as eligible for the proposed use of Kenacort-T Exclusion Criteria: Use of thumb orthosis 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 or intramuscular 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 (such as ibuprofen, diclofenac, etorocoxib, 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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Arm Label

    Intraarticular corticosteroid injection (IACS)

    Saline injection

    Occupational Therapy intervention

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Thumb base joint pain
    Change in thumb base joint pain last 24 hours on a Numeric Rating Scale (NRS)

    Secondary Outcome Measures

    Thumb base joint pain
    Change in thumb base joint pain last 24 hours on a Numeric Rating Scale (NRS)
    Finger joint pain
    Change in finger joint pain last 24 hours on a Numeric Rating Scale (NRS)
    AUSCAN
    Change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain, stiffness and function subscales.
    OMERACT-OARSI criteria responders
    Number of OMERACT-OARSI criteria responders
    MAP-Hand
    Change in measure of activity performance of the hand
    Patient-reported overall disease activity
    Change in patient-reported overall disease activity in hands last 24 hours on a Numeric Rating Scale (NRS)
    Assessor-reported overall disease activity
    Change in assessor-reported overall disease activity in hands on a Numeric Rating Scale (NRS)
    Pain in finger joints (hand figure)
    Change in pain in finger joints last 24 hours (hand figure)
    Grip strength
    Change in grip strength
    Use of analgesics
    Change in use of analgesics
    Use of NSAIDs
    Change in use of NSAIDs
    Arthritis self-efficacy scale
    Change in arthritis self-efficacy scale
    Patient satisfaction
    Number of responders regarding patient satisfaction
    EuroQol 5 dimensions 5-levels (EQ-5D-5L)
    Change in EuroQol 5 dimensions 5-levels (EQ-5D-5L)
    Tender hand joints
    Change in number of tender hand joints
    Swollen hand joints
    Change in number of swollen hand joints
    Ultrasound synovitis in the CMC-1 joint
    Change in ultrasound synovitis in the CMC-1 joint
    Synovitis in the CMC-1 joint
    Change in MRI synovitis in the CMC-1 joint on contrast-enhanced MRI
    Bone marrow lesions in the CMC-1 joint
    Change in bone marrow lesions in the CMC-1 joint on contrast-enhanced MRI
    Structural progression
    Change in structural progression by Kellgren-Lawrence
    Osteophytes
    Change in osteophytes by OARSI atlas
    Joint space narrowing
    Change in joint space narrowing by OARSI atlas
    Subluxation of the CMC-1 joint
    Change in subluxation of the CMC-1 joint
    Adverse events
    Number of adverse events
    Serious adverse events
    Number of serious adverse events
    Withdrawals because of adverse events
    Number of withdrawals because of adverse events
    Use of healthcare services
    Questions about use of healthcare services

    Full Information

    First Posted
    October 11, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Diakonhjemmet Hospital
    Collaborators
    Martina Hansen's Hospital, Helse Stavanger HF, Haugesund Rheumatism Hospital, St. Olavs Hospital, Nordlandssykehuset HF
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06084364
    Brief Title
    Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
    Acronym
    PICASSO
    Official Title
    Painful Inflammatory Carpometacarpal-1 Osteoarthritis Treated With Intraarticular Steroids, Saline or an Occupational Therapy Intervention: the PICASSO Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2025 (Anticipated)
    Study Completion Date
    October 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Diakonhjemmet Hospital
    Collaborators
    Martina Hansen's Hospital, Helse Stavanger HF, Haugesund Rheumatism Hospital, St. Olavs Hospital, Nordlandssykehuset HF

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    The participants and the occupational therapist who examine the patients are blinded for the content of the intraarticular injections. The rheumatologist who perform the intrarticular injection will not be blinded for the content.
    Allocation
    Randomized
    Enrollment
    354 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intraarticular corticosteroid injection (IACS)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Saline injection
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Occupational Therapy intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Injection of triamcinolone acetonide into the CMC-1 joint
    Other Intervention Name(s)
    Kenacort-T 40 mg/ml
    Intervention Description
    intraarticular injection with triamcinolone acetonide
    Intervention Type
    Behavioral
    Intervention Name(s)
    Multimodal Occupational therapy for CMC-1 joint OA
    Intervention Description
    Patient education, instructions about hand exercises, orthosis and training
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Sodium chloride 9 mg/ml
    Intervention Description
    Intraarticular injection with saline
    Primary Outcome Measure Information:
    Title
    Thumb base joint pain
    Description
    Change in thumb base joint pain last 24 hours on a Numeric Rating Scale (NRS)
    Time Frame
    4 and 12 weeks
    Secondary Outcome Measure Information:
    Title
    Thumb base joint pain
    Description
    Change in thumb base joint pain last 24 hours on a Numeric Rating Scale (NRS)
    Time Frame
    All visits
    Title
    Finger joint pain
    Description
    Change in finger joint pain last 24 hours on a Numeric Rating Scale (NRS)
    Time Frame
    Week 00, 04, 12, 24, 104
    Title
    AUSCAN
    Description
    Change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain, stiffness and function subscales.
    Time Frame
    Week 00, 04,12, 24 and 104
    Title
    OMERACT-OARSI criteria responders
    Description
    Number of OMERACT-OARSI criteria responders
    Time Frame
    Week 00, 04, 12, 24, 104
    Title
    MAP-Hand
    Description
    Change in measure of activity performance of the hand
    Time Frame
    Week 00, 04,12, 24 and 104
    Title
    Patient-reported overall disease activity
    Description
    Change in patient-reported overall disease activity in hands last 24 hours on a Numeric Rating Scale (NRS)
    Time Frame
    Week 00, 04, 12, 24, 104
    Title
    Assessor-reported overall disease activity
    Description
    Change in assessor-reported overall disease activity in hands on a Numeric Rating Scale (NRS)
    Time Frame
    Week 00, 04, 12, 24, 104
    Title
    Pain in finger joints (hand figure)
    Description
    Change in pain in finger joints last 24 hours (hand figure)
    Time Frame
    Week 00, 04, 12, 24, 104
    Title
    Grip strength
    Description
    Change in grip strength
    Time Frame
    Week 00, 04, 12, 24, 104
    Title
    Use of analgesics
    Description
    Change in use of analgesics
    Time Frame
    Week 00, 04, 12, 24, and 104
    Title
    Use of NSAIDs
    Description
    Change in use of NSAIDs
    Time Frame
    Week 00, 04, 12, 24, and 104
    Title
    Arthritis self-efficacy scale
    Description
    Change in arthritis self-efficacy scale
    Time Frame
    Week 00, 04, 12, 24, 104
    Title
    Patient satisfaction
    Description
    Number of responders regarding patient satisfaction
    Time Frame
    Week 04, 12
    Title
    EuroQol 5 dimensions 5-levels (EQ-5D-5L)
    Description
    Change in EuroQol 5 dimensions 5-levels (EQ-5D-5L)
    Time Frame
    Week 00, 04, 12, 24,104
    Title
    Tender hand joints
    Description
    Change in number of tender hand joints
    Time Frame
    Week 00, 04, 12, 24, 104
    Title
    Swollen hand joints
    Description
    Change in number of swollen hand joints
    Time Frame
    Week 00, 04, 12, 24, 104
    Title
    Ultrasound synovitis in the CMC-1 joint
    Description
    Change in ultrasound synovitis in the CMC-1 joint
    Time Frame
    Week 00, 04,12, 24, W104
    Title
    Synovitis in the CMC-1 joint
    Description
    Change in MRI synovitis in the CMC-1 joint on contrast-enhanced MRI
    Time Frame
    Week 00, 04
    Title
    Bone marrow lesions in the CMC-1 joint
    Description
    Change in bone marrow lesions in the CMC-1 joint on contrast-enhanced MRI
    Time Frame
    Week 00, 04
    Title
    Structural progression
    Description
    Change in structural progression by Kellgren-Lawrence
    Time Frame
    Week 00, 104
    Title
    Osteophytes
    Description
    Change in osteophytes by OARSI atlas
    Time Frame
    Week 00, 104
    Title
    Joint space narrowing
    Description
    Change in joint space narrowing by OARSI atlas
    Time Frame
    Week 00, 104
    Title
    Subluxation of the CMC-1 joint
    Description
    Change in subluxation of the CMC-1 joint
    Time Frame
    Week 00, 104
    Title
    Adverse events
    Description
    Number of adverse events
    Time Frame
    Week 00, 04, 12, 24, 104
    Title
    Serious adverse events
    Description
    Number of serious adverse events
    Time Frame
    Week 00, 04, 12, 24, 104
    Title
    Withdrawals because of adverse events
    Description
    Number of withdrawals because of adverse events
    Time Frame
    Week 00, 04, 12, 24, 104
    Title
    Use of healthcare services
    Description
    Questions about use of healthcare services
    Time Frame
    Week 00, 12, 24, 104

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Adult (40-85 years of age) men and women In target joint: OA confirmed by radiographs or ultrasound examination Inflammation by ultrasound (grey scale synovitis grade 1-3) Pain of at least 3 on a 0-10 Numeric Rating Scale (NRS) at both pre-screening and screening. Patient is assessed as eligible for the proposed use of Kenacort-T Exclusion Criteria: Use of thumb orthosis 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 or intramuscular 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 (such as ibuprofen, diclofenac, etorocoxib, 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ida Kristin Haugen, MD, PhD
    Phone
    +4795859884
    Email
    Ida.Haugen@diakonsyk.no
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marthe Gløersen, MD
    Phone
    +4748109310
    Email
    Marthe.Gloersen@diakonsyk.no
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ida Kristin Haugen, MD, PhD
    Organizational Affiliation
    Diakonhjemmet Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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