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Recruiting NCT05637294

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

Conditions: Carpal Tunnel Syndrome

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 110
Sponsor: Tampere University Hospital

Location: Finland

Summary

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 previously untreated 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.).

Eligibility Criteria

Inclusion Criteria:Clinically and electro-diagnostically confirmed carpal tunnel syndrome (CTS) of any severity level (diagnostic criteria: numbness, pain or paraesthesia in the median nerve distribution area of wrist and fingers; electrodiagnostic findings consistent with CTS: delayed motor or sensory latency, decreased conduction velocity, reduced amplitude of sensory nerve action potential),Symptom duration of CTS for at least 3 weeks,Treatment naive CTS,Aged 18 years or older,Able to complete self-report questionnaires electronically,Able to understand Finnish,Willing to join the study and follow the study protocol instructions,Sign informed consent.Exclusion Criteria:Cervical radiculopathy,Other neurological condition affecting the function of the hand such as Multiple Sclerosis, previous nerve injury,Active Rheumatoid arthritis or any other active inflammatory joint disease affecting the hand,Thenar muscle atrophy,Hypothyroidism,Known allergy to any of the splint materials (self-reported by patient),Any other known reason that could prevent from participation for the study time.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05637294). StuddyBuddy aggregates publicly available trial information.