Effect of Night-time and Full-time Splinting for Carpal Tunnel Syndrome: a Multi-center, Three-period, Randomized Cross-over Superiority Trial (FINCROSS - Finnish Crossover Trial for Carpal Tunnel Syndrome)

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Clinically 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),

• Symptom duration of CTS for at least 3 weeks,

• No previous corticosteroid injection for CTS during last 6 months,

• No previous surgery for 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.

Locations
Other Locations
Finland
Terveystalo Kamppi
RECRUITING
Helsinki
Hospital Nova of Central Finland
RECRUITING
Jyväskylä
Terveystalo Jyväskylä
RECRUITING
Jyväskylä
Mikkeli Central Hospital
RECRUITING
Mikkeli
Tampere University Hospital
ACTIVE_NOT_RECRUITING
Tampere
Terveystalo Tampere
RECRUITING
Tampere
Contact Information
Primary
Vieda Lusa
fincross.trial@gmail.com
+358408713465
Time Frame
Start Date: 2023-02-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 110
Treatments
Other: Sequence of three treatment periods in the following order: ABC
Splinting at night while sleeping for 6 weeks (period A), then no treatment for 6 weeks (period B), then splinting at day and night for 6 weeks (period C). Each treatment period will be separated by 3-week washout period.
Other: Sequence of three treatment periods in the following order: ACB
Splinting at night while sleeping for 6 weeks (period A), then splinting at day and night for 6 weeks (period C), then no treatment for 6 weeks (period B). Each treatment period will be separated by 3-week washout period.
Other: Sequence of three treatment periods in the following order: BAC
No treatment for 6 weeks (period B), then splinting at night while sleeping for 6 weeks (period A), then splinting at day and night for 6 weeks (period C). Each treatment period will be separated by 3-week washout period.
Other: Sequence of three treatment periods in the following order: BCA
No treatment for 6 weeks (period B), then splinting at day and night for 6 weeks (period C), then splinting at night while sleeping for 6 weeks (period A). Each treatment period will be separated by 3-week washout period.
Other: Sequence of three treatment periods in the following order: CAB
Splinting at day and night for 6 weeks (period C), then splinting at night while sleeping for 6 weeks (period A), then no treatment for 6 weeks (period B). Each treatment period will be separated by 3-week washout period.
Other: Sequence of three interventions/treatments in the following order: CBA
Splinting at day and night for 6 weeks (period C), then no treatment for 6 weeks (period B), then splinting at night while sleeping for 6 weeks (period A). Each treatment period will be separated by 3-week washout period.
Sponsors
Collaborators: Terveystalo, Mikkeli Central Hospital, Hospital Nova of Central Finland
Leads: Tampere University Hospital

This content was sourced from clinicaltrials.gov