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Effect of Night-time and Full-time Splinting for Carpal Tunnel Syndrome

Study acronym: FINCROSS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Dec 2026 → Dec 2028
See other at-risk trials from Tampere University Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Dec 2026 to Dec 2028
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 6 of 15 entries
  2. Minor Eligibility criteria expanded, about 5 wordsv7
  3. Notable Primary and study completion dates: Dec 2025 to Dec 2026
    • Study sites: 5 to 6
    • Collaborators: 2 to 3
    v6
  4. Minor Eligibility criteria expanded, about 21 wordsv5
  5. Minor Study sites: 4 to 5
    • Collaborators: 1 to 2
    • Eligibility criteria shortened, about 4 words
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Start date changed from estimate of Dec 2022 to Feb 15, 2023v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 4 of 4 sites
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a common compression neuropathy of upper extremities. Its usual symptoms are pain, numbness and tingling of fingers, which tend to be worse at night. Splinting the wrist with an external orthosis is usually a first-line treatment provided to most people with mild to moderate disease. The FINCROSS trial (randomized cross-over trial) aims to assess the effect of night-time and full-time splinting in comparison with no-treatment. It also aims to identify possible subgroups of people who would benefit from splinting, as well as assess if positive response to splinting is associated with subsequent lower need of surgery. The trial will recruit 110 people with carpal tunnel syndrome in Finland. Each participant will undergo all three treatment periods in a randomised order: 1) splinting at night-time for six weeks, 2) splinting both day and night for six weeks; and 3) be assessed under a six weeks long control period of no-treatment. Each treatment period will be separated with a three-week washout period. Therefore, the whole treatment sequence for each participant lasts 24 weeks after randomization. The participant will be followed-up to 1 year after the randomisation. Additionally, the participants will get instructions for self-administered stretching exercises to perform throughout the study. All participants will be asked to avoid any intervention administered or supervised by medical personnel (such as structured supervised exercises, manual therapy, steroid injections, surgery, etc.).
Trial Details
NCT Number NCT05637294
Lead Sponsor Tampere University Hospital
Collaborators: Terveystalo, Hospital Nova, Central Finland, Mikkeli Central Hospital
Conditions
(from sponsor)
Carpal Tunnel Syndrome
Related terms Carpal Tunnel Syndrome
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov