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A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome

Study acronym: NOR-CACTUS
StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 5 of 5 sites
    v9
  2. Primary completion date: Dec 2025 to Mar 2027
    • Study completion date: Dec 2026 to Mar 2028
    v8
  3. Study sites: 4 to 5
    • Collaborators: 3 to 4
    v7
  4. Interventions: Injection, Triamcinolone Hexacetonide (Drug), Surgical carpal tunnel release (Procedure) to Injection, Triamcinolone Hexacetonide, Per 5 Mg (Drug), Surgical carpal tunnel release (Procedure)v6
  5. Primary completion date: Dec 2024 to Dec 2025
    • Study completion date: Dec 2025 to Dec 2026
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Site details revised at 2 of 4 sitesv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2022 to Apr 8, 2022
    • Site details revised at 4 of 4 sites
    v3
  3. Start date: Mar 2022 to Apr 2022
    • Secondary endpoints: details revised at 1 of 44 entries
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Carpal tunnel syndrome (CTS) causes numbness and pain in the hand and arm, and is an important cause of work absence and disability. The aim of the NOR-CACTUS Trial is to compare outcomes of a treatment strategy where the initial treatment is up to two ultrasound-guided corticosteroid injections, followed by scheduled clinical assessment of treatment effect, and subsequent surgery if needed, to a treatment strategy where surgery is the first-line treatment. Participants will be randomized to one of the treatment strategies, and followed up for two years after start of the study intervention. Outcomes will include patient-reported, clinical, functional and neurophysiological measures, and health-economic aspects. The hypothesis of the study is that there is no difference between the two treatment groups in the percentage of patients with a satisfactory symptom relief (treatment success) one year after the initial therapeutic intervention.
Trial Details
NCT Number NCT05306548
Lead Sponsor Diakonhjemmet Hospital
Collaborators: Oslo University Hospital, Vestre Viken Hospital Trust, South-Eastern Norway Regional Health Authority, University Hospital, Akershus
Conditions
(from sponsor)		 Carpal Tunnel Syndrome
Related terms Carpal Tunnel Syndrome
Enrollment 258 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov