Trials in Canterbury
As there are considerable uncertainties about the effectiveness of several forms of therapy for carpal tunnel syndrome we are planning a small selection of treatment trials in Canterbury. These trials are in various states of preparation as noted below. If you wish to participate in any of these please discuss it with us when you attend for testing.
2007 cohort study
We have recently attempted to follow up all of the patients who were first seen by us for carpal tunnel syndrome in 2007 and began treatment with local steroid injection. Some of you we have seen recently and we already know how your symptoms have responded to treatment but there are 235 patients with whom we have had no contact for more than a year. We wrote to these 235 patients during the week beginning 13th April 2015 with an invitation to participate in this small study. The only action required of patients who received one of these letters was to reply to us with some further information about the current state of their CTS symptoms and any further treatment they have had. Patients are however welcome to contact us through the website forums or by other means to ask further questions. We obtained full follow-up data from 157 patients, 22 were deceased and 75 either could not be contacted or declined to provide full information on their current symptoms and treatment. The resulting paper is currently being considered for publication and results will be summarised here once it is published.
This is a pilot study funded by the British Society for Surgery of the Hand which takes patients with moderately severe CTS and randomly allocates them to either local steroid injection or surgery as first line treatment. The aim is to collect 40 patients across 4 different UK hospitals and to follow them up for 1 year to assess the outcomes. This is mostly being done as a afeasibility study for a larger multi-centre study.
Therapeutic ultrasound for CTS
The three existing methodologically reasonable trials of ultrasound treatment have conflicting results. We are therefore carrying out a further randomised, double blind trial of this treatment to try and resolve the issue once and for all, replicating the methodology of the one existing trial which reported a positive effect of ultrasound. Ultrasound treatment is very safe and painless but is quite time consuming - five visits per week for two weeks followed by two visits per week for 5 weeks - each taking about 20 minutes or so. It therefore requires a good deal of time and commitment from the patient. We carry out these treatments in the early evening so that hopefully they can be after work for most people. We are now recruiting patients who would like to try this treatment but you must appreciate that, as this is a randomised double blind placebo controlled trial, that only half of the patients who volunteer will actually be treated with ultrasound. If you would like to participate in this trial please ask us when you attend for testing.
'C-trac' splinting for CTS
The C-trac splint is a US patented device which attempts to stretch the transverse carpal ligament using externally applied pressure. We have no business connection with the manufacturer/vendor and we are planning to complete a trial which has been performed partially in Canada. This is awaiting ethical committee approval here in the UK at present.
Single or double local steroid injections for CTS
One previous study comparing surgery with steroid injection for CTS used an unusual injection protocol in which one injection was given initially. The patients were then reviewed two weeks later and, if there were still ANY residual symptoms, given a second injection. Thus only patients who were totally asymptomatic after one injection received a single dose. All other patients (the majority) had two consecutive injections two weeks apart. The study is interesting because the clinical outcomes in the injection group were unusually good for a steroid injection study. We would like to compare this 'conditional second injection' approach with our current policy of using a single injection only as initial treatment to see if it really is more effective. This idea has not yet been submitted for research governance/ethics approval however and is unlikely to start for some time.
Choice of steroid and dose for CTS injection
There are only two previous studies comparing different steroids/doses in the treatment of CTS, one small and methodologically poor one (O'gradaigh 2000) and one very good one (Atroshi 2013 - see the trial evidence page). At present most trials which have reported good results from steroid injection have used 40mg methyprednisolone or equivalent. Dr Atroshi's study suggests that those given 80mg had a lower rate of surgery at one year, whereas Dr O'Gradaigh's paper suggested that dose and steroid choice made little difference. More work is clearly needed and we may consider a study in Canterbury comparing doses and steroids.
There is a fair amount of research interest in carpal tunnel syndrome at present and the following are links to significant trials in progress now:
INSTINCTS - Coordinated by the University of Keele, this prospective, randomised study compares a single injection of 20mg depo-medrone with 6 weeks of splinting in patients diagnosed as having CTS by their general practitioner or a hospital clinic on clinical grounds (ie without confirmation by nerve conduction studies). The intention is to follow up patients for 2 years.
CAPS - Imperial College is conductiing a study of pain in CTS, attemting to elucidate the impact of neuropathic pain and somatosensory phenotype on post-operative outcome. This study needs more patients and may try to recruit some patients in Canterbury if we can arrange facilities and research governance approval in time.
PALMS - a prospective, observational study of prognostic factors in the treatment of CTS is coordinated form the University of East Anglia in Norwich. It has finished recruiting and is following up a cohort of patients for 2 years without interfering in their treatment to try and identify prognostic factors.
Revision date - 2nd May 2016