Ignite Creation Date:
2024-05-06 @ 12:31 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01590745
Status:
COMPLETED
Last Update Posted:
2018-01-31
First Post:
2012-04-26
Brief Title:
Ultrasound Therapy for Carpal Tunnel Syndrome CTS
Sponsor:
East Kent Hospitals University NHS Foundation Trust
Organization:
East Kent Hospitals University NHS Foundation Trust
Study Overview
Official Title:
A Randomised Controlled Double Blind Trial Of Therapeutic Ultrasound in Carpal Tunnel Syndrome CTS
Status:
COMPLETED
Status Verified Date:
2018-01
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:
CTS
Brief Summary:
Carpal Tunnel Syndrome CTS is a recognisable pattern of symptoms and signs which are caused by compression of the median middle nerve as it passes through the carpal tunnel at the wrist
This condition affects individuals by causing pain numbness tingling sensations and sometimes weakness in the fingers and may extend to shoulder and neck areas The cause for most cases is unknown idiopathic though some common conditions are associated with an increased incidence including obesity pregnancy hypothyroidism arthritis diabetes and trauma
Diagnosis is primarily clinical and the condition is easily recognised from the characteristic symptoms in straightforward cases but diagnostic support is provided by investigations such as nerve conduction studies and ultrasound imaging
Treatment may include splinting local steroid injection at wrist activity modificationphysical or occupational therapy controversial medications and surgery Treatment with local therapeutic ultrasound has been suggested to be effective but existing trials are inconclusive
Wrist splinting is only partially effective with a success rate of 34 Steroid injection is followed by frequent relapses and there remains uncertainty about the safety of serial injections Surgery is effective but has a small but significant incidence of permanent complications Any demonstrably effective and safe addition to the therapeutic options would be a significant advance in treatment Therapeutic ultrasound at present appears a promising option having a very good safety record but so far uncertain evidence of efficacy
In our trial patients with mild carpal tunnel syndrome confirmed by nerve conduction studies will all be given wrist splints so that no patients will be left untreated They will be randomly allocated to either therapeutic or sham ultrasound therapy 20 sessions over 7 weeks and followed up for 1year The patients operators of the ultrasound equipment and assessors will all be blind to treatment allocation
The effect of treatment on symptoms will be assessed using a validated questionnaire and nerve conduction studies will be repeated at completion of the ultrasound treatment 6 and 12 months
This study is designed to find out to whether therapeutic ultrasound is an effective treatment for carpal tunnel syndrome CTS
This condition affects individuals by causing pain numbness tingling sensations and sometimes weakness in the fingers and may extend to shoulder and neck areas The cause for most cases is unknown idiopathic though some common conditions are associated with an increased incidence including obesity pregnancy hypothyroidism arthritis diabetes and trauma
Diagnosis is primarily clinical and the condition is easily recognised from the characteristic symptoms in straightforward cases but diagnostic support is provided by investigations such as nerve conduction studies and ultrasound imaging
Treatment may include splinting local steroid injection at wrist activity modificationphysical or occupational therapy controversial medications and surgery Treatment with local therapeutic ultrasound has been suggested to be effective but existing trials are inconclusive
Wrist splinting is only partially effective with a success rate of 34 Steroid injection is followed by frequent relapses and there remains uncertainty about the safety of serial injections Surgery is effective but has a small but significant incidence of permanent complications Any demonstrably effective and safe addition to the therapeutic options would be a significant advance in treatment Therapeutic ultrasound at present appears a promising option having a very good safety record but so far uncertain evidence of efficacy
In our trial patients with mild carpal tunnel syndrome confirmed by nerve conduction studies will all be given wrist splints so that no patients will be left untreated They will be randomly allocated to either therapeutic or sham ultrasound therapy 20 sessions over 7 weeks and followed up for 1year The patients operators of the ultrasound equipment and assessors will all be blind to treatment allocation
The effect of treatment on symptoms will be assessed using a validated questionnaire and nerve conduction studies will be repeated at completion of the ultrasound treatment 6 and 12 months
This study is designed to find out to whether therapeutic ultrasound is an effective treatment for carpal tunnel syndrome CTS
Detailed Description:
Carpal tunnel syndrome CTS is the commonest peripheral nerve disorder in the UK Average annual incidences per 100 000 were 1394 for women and 672 for men in East Kent UK
It has significant economic impact on average having the largest recuperation period of all injuries illness that require days away from work It causes tingling numbness or pain in the distribution of the median nerve the thumb index and middle fingers and half the ring finger that is often worse at night and causes wakening The pathology of idiopathic CTS is a non-inflammatory fibrosis of the subsynovial connective tissue surrounding the flexor tendons but the causes are not fully understood
Many treatments have been proposed but reviews performed by the Cochrane collaboration have found firm evidence in support of only
1 Surgical decompression of the carpal tunnel
2 Steroid therapy local injection or systemic administration
3 Neutral angle wrist splinting
None of the available evidence based treatments for CTS are entirely satisfactory Splinting is only partially effective with a success rate of 34 Steroid injection is followed by frequent relapses and there remains uncertainty about the safety of serial injections Surgery results in a small but significant incidence of permanent morbidity from complications
Any demonstrably effective and safe addition to the therapeutic options would be a significant advance Of the many candidate treatments therapeutic ultrasound at present appears the most promising and is therefore the subject of this proposal Therapeutic ultrasound has a very good safety record and is essentially non-invasive
In this trial patients with mild carpal tunnel syndrome confirmed by nerve conduction studies will all be given wrist splints They will be randomly allocated to either real or sham ultrasound therapy 20 sessions over 7 weeks and followed up for 1 year The effect of treatment on symptoms will be assessed using a validated questionnaire and nerve conduction studies will be repeated at completion of the ultrasound treatment at 7th week and further after 6 and 12 months time
This will be a randomised double blind single-centre clinical trial conducted by East Kent Hospitals University Foundation Trusts Kent and Canterbury Hospital with follow-up for 1 year from completion of treatment Following randomisation patients will be required to attend the clinic for 20 sessions over a 7 weeks period 5x weekly for 2 weeks then 2x weekly for 5 weeks
It has significant economic impact on average having the largest recuperation period of all injuries illness that require days away from work It causes tingling numbness or pain in the distribution of the median nerve the thumb index and middle fingers and half the ring finger that is often worse at night and causes wakening The pathology of idiopathic CTS is a non-inflammatory fibrosis of the subsynovial connective tissue surrounding the flexor tendons but the causes are not fully understood
Many treatments have been proposed but reviews performed by the Cochrane collaboration have found firm evidence in support of only
1 Surgical decompression of the carpal tunnel
2 Steroid therapy local injection or systemic administration
3 Neutral angle wrist splinting
None of the available evidence based treatments for CTS are entirely satisfactory Splinting is only partially effective with a success rate of 34 Steroid injection is followed by frequent relapses and there remains uncertainty about the safety of serial injections Surgery results in a small but significant incidence of permanent morbidity from complications
Any demonstrably effective and safe addition to the therapeutic options would be a significant advance Of the many candidate treatments therapeutic ultrasound at present appears the most promising and is therefore the subject of this proposal Therapeutic ultrasound has a very good safety record and is essentially non-invasive
In this trial patients with mild carpal tunnel syndrome confirmed by nerve conduction studies will all be given wrist splints They will be randomly allocated to either real or sham ultrasound therapy 20 sessions over 7 weeks and followed up for 1 year The effect of treatment on symptoms will be assessed using a validated questionnaire and nerve conduction studies will be repeated at completion of the ultrasound treatment at 7th week and further after 6 and 12 months time
This will be a randomised double blind single-centre clinical trial conducted by East Kent Hospitals University Foundation Trusts Kent and Canterbury Hospital with follow-up for 1 year from completion of treatment Following randomisation patients will be required to attend the clinic for 20 sessions over a 7 weeks period 5x weekly for 2 weeks then 2x weekly for 5 weeks
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