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

NCT06084364 | Recruiting Phase 4

• 1 other identifier: 2023-505254-17-00
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 6

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

Conditions

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

Outcome Measures

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.

  4 and 12 weeks

Secondary Outcomes (29)

• Pain during activities in thumb base joint

  All visits

• Pain at rest in thumb base joint

  Week 00, 04, 12, 24, 104

• Pain during activities in finger joints

  Week 00, 04, 12, 24, 104

• Pain at rest in finger joints

  Week 00, 04, 12, 24, 104

• AUSCAN (Australian/Canadian hand index)

  Week 00, 04,12, 24 and 104

Study Arms (3)

Intraarticular corticosteroid injection (IACS)

EXPERIMENTAL

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

Saline injection

PLACEBO COMPARATOR

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

Occupational Therapy intervention

EXPERIMENTAL

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

Multimodal Occupational therapy for CMC-1 joint OA BEHAVIORAL

Patient education, instructions about hand exercises, orthosis and training

Occupational Therapy intervention

Injection of triamcinolone acetonide into the CMC-1 joint DRUG

intraarticular injection with triamcinolone acetonide

Also known as: Kenacort-T 40 mg/ml

Intraarticular corticosteroid injection (IACS)

Placebo DRUG

Intraarticular injection with saline

Also known as: Sodium chloride 9 mg/ml

Saline injection

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haugesund Rheumatism Hospital: collaborator
• Nordlandssykehuset HF: collaborator
• Diakonhjemmet Hospital: lead
• Vestre Viken Hospital Trust: collaborator
• Helse Stavanger HF: collaborator
• St. Olavs Hospital: collaborator

Study Sites (6)

Nordlands Hospital

Bodø, Norway

RECRUITING

Haugesund Rheumatism Hospital

Haugesund, Norway

RECRUITING

Diakonhjemmet Hospital

Oslo, Norway

RECRUITING

Martina Hansens Hospital

Sandvika, Norway

ACTIVE NOT RECRUITING

Stavanger University Hospital

Stavanger, Norway

RECRUITING

St Olavs Hospital

Trondheim, Norway

RECRUITING

Related Publications (1)

• 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.

  PMID: 39669005 DERIVED

MeSH Terms

Conditions

Pain; Inflammation; Osteoarthritis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ida Kristin Haugen, MD, PhD

  Diakonhjemmet Hospital

  STUDY DIRECTOR

• Marte Ingeborg Sæther

  Martina Hansens Hospital

  PRINCIPAL INVESTIGATOR

• Elisabet Esperø

  Haugesund Rheumatism Hospital

  PRINCIPAL INVESTIGATOR

• Katrine Brække Norheim

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

• Mari Hoff

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

• Göran Karlsson

  Nordland Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ida Kristin Haugen, MD, PhD

CONTACT

+4795859884; Ida.Haugen@diakonsyk.no

Marthe Gløersen, MD

CONTACT

+4748109310; Marthe.Gloersen@diakonsyk.no

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants and the occupational therapist who examine the patients are blinded for the content of the intraarticular injections. The rheumatologist who perform the intraarticular injection will not be blinded for the content.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rheumatologist, senior researcher

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 16, 2023
• Study Start: November 3, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

NO (6)