Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05306548
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2022-03-14
Brief Title:
A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome
Sponsor:
Diakonhjemmet Hospital
Organization:
Diakonhjemmet Hospital
Study Overview
Official Title:
The NOR-CACTUS Trial - A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome
Status:
RECRUITING
Status Verified Date:
2024-04
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:
NOR-CACTUS
Brief Summary:
Carpal tunnel syndrome CTS causes numbness and pain in the hand and arm and is an important cause of work absence and disability The aim of the NOR-CACTUS Trial is to compare outcomes of a treatment strategy where the initial treatment is up to two ultrasound-guided corticosteroid injections followed by scheduled clinical assessment of treatment effect and subsequent surgery if needed to a treatment strategy where surgery is the first-line treatment Participants will be randomized to one of the treatment strategies and followed up for two years after start of the study intervention Outcomes will include patient-reported clinical functional and neurophysiological measures and health-economic aspects The hypothesis of the study is that there is no difference between the two treatment groups in the percentage of patients with a satisfactory symptom relief treatment success one year after the initial therapeutic intervention
Detailed Description:
CTS is the most common non-traumatic hand disorder prevalent in approximately 4 of the adult population The condition may have a substantial impact on an individuals quality of life ability to accomplish activities of daily living and to perform occupational duties Associated healthcare costs represent a significant socioeconomic burden
Currently many patients with mild and moderate CTS treated surgically without a preceding trial of less invasive non-surgical therapies An increase in the use of non-surgical first-line therapies eg corticosteroid injection into the carpal tunnel while reserving surgery for refractory cases aim to optimize the trade-off between treatment risk and benefit while also ensuring appropriate use of health resources However there is a lack of studies directly comparing the efficacy of corticosteroid injections to surgery and the long-term safety of corticosteroid injections has not been investigated
It is not well-known if patients who are initially treated with corticosteroid injections will eventually need to proceed to surgery and therefore may have to endure the symptoms for a longer period of time with potentially worse long-term outcomes compared to patients who has surgery as first-line treatment On the other hand it is not beneficial if patients are unnecessarily exposed to the risks associated with surgery if symptoms could have been satisfactory resolved with a non-surgical method
The current study will assess if first-line treatment with up to two ultrasound-guided corticosteroid injections is non-inferior to surgery with regards to treatment success A less invasive treatment approach might result in important benefits to the patient eg less pain reduced risk of complications and faster return to work and activities This might also be of importance to family members as many CTS patients are at an age where they have care responsibilities Non-surgical treatments might benefit society by decreasing work absence and reducing health expenditure and allowing better access to surgical services for other patient groups High quality documentation is needed to provide a base for future treatment guidelines Evidence based clinical guidelines provide treatment decision support and help reduce national and regional differences in treatment practices and ensure that all patients have equal access to evidence-based treatment
In the NOR-CACTUS trial adult individuals with idiopathic CTS of a mild-to-moderate degree will be randomized to receive either A Primary open surgical carpal tunnel release or B Up to two ultrasound-guided corticosteroid triamcinolone hexacetonide injections in the carpal tunnel and subsequent open surgical carpal tunnel release in case of unsatisfactory treatment result Participants will be randomized to receive one of the treatment strategies and followed for two years with the primary endpoint being successful treatment result one year after start of the intervention
The hypothesis of the study is that the percentage of patients with a satisfactory symptom relief treatment success one year after the initial therapeutic intervention in the injection treatment strategy arm is non-inferior to that of the surgery treatment arm The primary outcome is based on the disease-specific patient-reported outcome Boston Carpal Tunnel Questionnaire BCTQ symptom severity scale SSS Further outcomes will include other patient-reported clinical functional and neurophysiological measures and health-economic aspects
Currently many patients with mild and moderate CTS treated surgically without a preceding trial of less invasive non-surgical therapies An increase in the use of non-surgical first-line therapies eg corticosteroid injection into the carpal tunnel while reserving surgery for refractory cases aim to optimize the trade-off between treatment risk and benefit while also ensuring appropriate use of health resources However there is a lack of studies directly comparing the efficacy of corticosteroid injections to surgery and the long-term safety of corticosteroid injections has not been investigated
It is not well-known if patients who are initially treated with corticosteroid injections will eventually need to proceed to surgery and therefore may have to endure the symptoms for a longer period of time with potentially worse long-term outcomes compared to patients who has surgery as first-line treatment On the other hand it is not beneficial if patients are unnecessarily exposed to the risks associated with surgery if symptoms could have been satisfactory resolved with a non-surgical method
The current study will assess if first-line treatment with up to two ultrasound-guided corticosteroid injections is non-inferior to surgery with regards to treatment success A less invasive treatment approach might result in important benefits to the patient eg less pain reduced risk of complications and faster return to work and activities This might also be of importance to family members as many CTS patients are at an age where they have care responsibilities Non-surgical treatments might benefit society by decreasing work absence and reducing health expenditure and allowing better access to surgical services for other patient groups High quality documentation is needed to provide a base for future treatment guidelines Evidence based clinical guidelines provide treatment decision support and help reduce national and regional differences in treatment practices and ensure that all patients have equal access to evidence-based treatment
In the NOR-CACTUS trial adult individuals with idiopathic CTS of a mild-to-moderate degree will be randomized to receive either A Primary open surgical carpal tunnel release or B Up to two ultrasound-guided corticosteroid triamcinolone hexacetonide injections in the carpal tunnel and subsequent open surgical carpal tunnel release in case of unsatisfactory treatment result Participants will be randomized to receive one of the treatment strategies and followed for two years with the primary endpoint being successful treatment result one year after start of the intervention
The hypothesis of the study is that the percentage of patients with a satisfactory symptom relief treatment success one year after the initial therapeutic intervention in the injection treatment strategy arm is non-inferior to that of the surgery treatment arm The primary outcome is based on the disease-specific patient-reported outcome Boston Carpal Tunnel Questionnaire BCTQ symptom severity scale SSS Further outcomes will include other patient-reported clinical functional and neurophysiological measures and health-economic aspects
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