Ignite Creation Date:
2024-05-06 @ 6:21 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05637294
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2022-10-18
Brief Title:
Effect of Night-time and Full-time Splinting for Carpal Tunnel Syndrome
Sponsor:
Tampere University Hospital
Organization:
Tampere University Hospital
Study Overview
Official Title:
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
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FINCROSS
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None