Ignite Creation Date:
2024-05-06 @ 2:22 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02038452
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2014-01-09
Brief Title:
Injection Versus Splinting in Carpal Tunnel Syndrome
Sponsor:
Keele University
Organization:
Keele University
Study Overview
Official Title:
Randomised Multicentre Open Label Parallel Group Pragmatic Clinical Trial of Local Steroid Injection Versus Night Splinting in Mild to Moderate Carpal Tunnel Syndrome CTS
Status:
COMPLETED
Status Verified Date:
2023-03
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:
INSTinCTS
Brief Summary:
Carpal Tunnel Syndrome CTS is a common condition in which a nerve known as the median nerve is squeezed where it passes through the wrist It can cause pain or aching tingling or numbness in the affected hand It may disturb sleep or affect ability to do day to day things
There have been several studies into the best treatment of patients with severe symptoms of CTS who are referred to a hospital for treatment However little is known about the best treatments for patients with mild to moderate symptoms who visit their GP but do not require hospital treatment
The study will investigate whether a steroid injection is clinically effective in reducing symptoms and improving function in the short term 6 weeks compared to a night splint in people consulting with mild to moderate CTS in primary careWe will study the effects of these 2 treatments over 6 weeks and at 6 months Subject to further funding the Study will also look at whether these 6 weeks of treatment are effective 1 year and 2 years later
The study will take place in up to 50 GP practices and hospital clinics across the UK Patients aged 18 and over who have been diagnosed with mild to moderate CTS which has been present for at least 6 weeks will be eligible for inclusion
The steroid is a drug called DepoMedrone This drug is already widely used to treat CTS In this study one injection will be given The splint is made of elastic and has an aluminium bar which sits on the palm of the hand In this study the splint will be worn at night for 6 weeks Each participant will receive either a single steroid injection or a splint and will be asked to complete up to 5 questionnaires over 2 years
There have been several studies into the best treatment of patients with severe symptoms of CTS who are referred to a hospital for treatment However little is known about the best treatments for patients with mild to moderate symptoms who visit their GP but do not require hospital treatment
The study will investigate whether a steroid injection is clinically effective in reducing symptoms and improving function in the short term 6 weeks compared to a night splint in people consulting with mild to moderate CTS in primary careWe will study the effects of these 2 treatments over 6 weeks and at 6 months Subject to further funding the Study will also look at whether these 6 weeks of treatment are effective 1 year and 2 years later
The study will take place in up to 50 GP practices and hospital clinics across the UK Patients aged 18 and over who have been diagnosed with mild to moderate CTS which has been present for at least 6 weeks will be eligible for inclusion
The steroid is a drug called DepoMedrone This drug is already widely used to treat CTS In this study one injection will be given The splint is made of elastic and has an aluminium bar which sits on the palm of the hand In this study the splint will be worn at night for 6 weeks Each participant will receive either a single steroid injection or a splint and will be asked to complete up to 5 questionnaires over 2 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20105 | OTHER_GRANT | None | None |
| 2013-001435-48 | EUDRACT_NUMBER | None | None |
| 13NW0280 | OTHER | None | None |
| 09392969 | REGISTRY | ISRCTN | None |