Carpal Tunnel Syndrome Clinical Trial
Official title:
A Randomised Controlled Double Blind Trial Of Therapeutic Ultrasound in Carpal Tunnel Syndrome (CTS)
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
modification,physical 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).
Carpal tunnel syndrome (CTS) is the commonest peripheral nerve disorder in the UK. Average
annual incidences (per 100 000) were 139.4 for women and 67.2 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).
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