Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05637294

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

Led by Tampere University Hospital · Updated on 2025-08-12

110

Participants Needed

6

Research Sites

197 weeks

Total Duration

On this page

Sponsors

T

Tampere University Hospital

Lead Sponsor

T

Terveystalo

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinically confirmed carpal tunnel syndrome of any severity with symptoms like numbness, pain, or tingling in the median nerve area
  • Symptoms present for at least 3 weeks
  • No corticosteroid injections for carpal tunnel syndrome in the past 6 months
  • No prior surgery for carpal tunnel syndrome
  • Age 18 years or older
  • Able to complete electronic self-report questionnaires
  • Able to understand Finnish language
  • Willing to participate and follow study instructions
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Nerve root or plexus disorders causing similar symptoms, such as cervical radiculopathy or thoracic outlet syndrome
  • Other neurological conditions affecting hand function, including Multiple Sclerosis or previous nerve injury
  • Active rheumatoid arthritis or other inflammatory joint diseases affecting the hand
  • Thenar muscle atrophy
  • Untreated hypothyroidism
  • Known allergy to splint materials
  • Long-term treatment for carpal tunnel syndrome over 4 months without response
  • Any other condition preventing participation during the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Terveystalo Kamppi

Helsinki, Finland

Actively Recruiting

2

Hospital Nova of Central Finland

Jyväskylä, Finland

Actively Recruiting

3

Terveystalo Jyväskylä

Jyväskylä, Finland

Actively Recruiting

4

Mikkeli Central Hospital

Mikkeli, Finland

Actively Recruiting

5

Tampere University Hospital

Tampere, Finland

Active, Not Recruiting

6

Terveystalo Tampere

Tampere, Finland

Actively Recruiting

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Research Team

V

Vieda Lusa

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

6

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