Alternative and unproven treatments
This page contains notes on all of the treatment alternatives which have come to my notice without there being concrete evidence that they are effective. The proponents of some of the commercialised alternatives will take me to task for saying that they have no proof of efficacy but I am not alone in this - they should consult the Cochrane Database Articles and consider what the standard of proof required is. They appear here in no particular order. I have chosen a representative sample of the 'evidence' for each treatment - often there is only a single published paper supporting one of these therapies. The methods covered are listed here, more or less alphabetically. (New additions not yet incorporated into the alphabetic list will be found at the bottom of the page)
Acupuncture and Laser Acupuncture
Carpal bone mobilization, Neurodynamic mobilization
Cognitive behavioural therapy
ESWT - Extracorporeal shockwave therapy
Hormone replacement therapy
Infra-red therapy gloves***
Iontophoresis and Phonophoresis
Ischaemic compression therapy
Ligament stretching devices 'C-trac'***
Local anaesthetic injection
Oscillatory Biofield Therapy
‘Penetrex’ (Topical herbs and B6)***
Percutaneous needle release
Physiotherapy and exercises
Rest (and job modification)
TENS (Transcutaneous Electrical Nerve Stimulation)
Vitamin B6 (Pyridoxine)
*** A few of these are proprietory remedies which you will find advertised on the internet and elsewhere. I have included their trade names here which may seem to be a breach of my own rules on advertising on this site. There seems to be no way to avoid confusion about which treatments I am discussing without doing this. I must however emphasise that I am NOT endorsing the use of any of these treatments outside the context of a properly conducted, randomised, double blind clinical trial, and I have not provided links to the manufacturers sites. If readers wish to read the manufacturers promotional publicity you will have to search for it.
- May 2002 - is fairly typical of the sort of ‘evidence’ produced to prove not only that CTS is an occupational disease, but also that modifying the workplace can reduce the incidence. The incidence data are derived from occupational health records and work sites with a very high incidence of reported CTS were targeted for inspection. Their incidence of ‘CTS’ then fell precipitously but it is not clear whether this is really due to less cases or simply to more rigorous diagnosis once attention is focussed on the problem.
First reported by Banta 1994, these are promising methods for delivering steroids locally to the carpal tunnel without significant systemic steroid side effects and without having to insert a needle into or near the carpal tunnel. Subsequent studies however have suggested that the effectiveness of steroids delivered in this way is perhaps less and treatment sessions can be long and intrusive.
- have a venerable pedigree as CTS treatment, first reported in the BMJ 50 years ago (Heathfield 1961) and are often prescribed in primary care. However the few randomised controlled double blind trials suggest that they are no more effective than placebo (Pal 1988, Chang 1998)
Despite being widely recommended as an initial treatment for CTS the only reliable placebo controlled trial (Chang 1998) suggests that they are no more effective than placebo. Furthermore, I have been asking patients for years whether their symptoms respond to over the counter NSAID’s such as Ibuprofen and 62% of 6304 CTS patients said no - so if you have hand pain related to CTS and it is not responding to over the counter medicines that is in fact fairly typical.
Local anaesthetics (lidocaine/procaine/benzocaine etc) are frequently given along with steroids as part of injection treatment for CTS. The logic behind this is usually an attempt to either reduce the pain of the injection itself or to demonstrate placement of the injection near the median nerve by producing anaesthesia in the median nerve territory for a while after injection. However a Turkish group has become interested in whether the local anaesthetic itself might have a therapeutic effect in CTS and has published two papers looking into the issue (Karadas 2011 and Karadas 2012). In the first of these, one group of patients was given steroid alone, one group procaine alone, and one group both. The group given both drugs obtained the best outcome but the authors argued that the procaine only group also improved significantly. As there was no true placebo control group in this study we cannot tell if the procaine actually had any effect or whether these patients might have improved without any treatment at all. The same authors then went on to study a group of 22 patients given not only an initial injection of triamcinolone and procaine but also 4 follow up injections of procaine only over a 2 week period. This single cohort of patients showed improvements in symptoms, nerve conduction results and ultrasound measurements of median nerve size at two months follow-up, but again there is no control group and this study does not tell us anything about the efficacy of the additional procaine injections.
The Vitamin B6 (Pyridoxine) story dates back to a series of publications by Ellis and co-workers beginning in 1976 (Ellis 1976, Folkers 1976) These are very poor quality studies with small numbers of patients, often very scanty evidence that the subjects actually had CTS, poor or no control patients and questionable evidence of B6 deficiency. Nevertheless these studies sparked a small industry in treating CTS with vitamin B6. When good quality studies were eventually done they generally showed no significant therapeutic effect of pyridoxine (Franzblau 1996). A recent review of the literature relating to therapeutic uses of Vitamin B6 in the Journal of Evidence-Based Complementary and Alternative Medicine has again concluded that there is no reliable evidence that pyridoxine has any beneficial effect on CTS (Bender 2011).
Rifampicin (Namazi 2008)
It has been suggested that the anti-tuberculosis drug Rifampicin, which has effects on the immune system, including the downregulation of interleukin-1, interleukin-17, Tumour Necrosis Factor(TNF) and Transforming Growth Factor-beta (TGF-β), might be useful as a treatment for CTS. TGF-β is a potent stimulator of fibrosis and is present in CTS tissue samples. This suggestion is logical but has not, so far as I know, been tried out in practice. No route of administration was suggested and rifampicin is of course not without side effects including, though rarely, serious liver disease.
Exercise programmes (nerve/tendon gliding) (Akalin 2002)
A small, unblinded study which randomly allocated 28 patients to treatment with either splinting alone, or splinting with additional nerve and tendon gliding exercises. 4 patients in each group of 14 had bilateral symptoms so 18 hands were treated in each group. No statistically significant differences in outcome were detected either at the end of treatment after 4 weeks or during an average period of 8 months follow-up, though both patient groups showed considerable improvement in symptoms. The major problems with this study are the lack of blinding of both patients and assessors, it's small size which gives it insufficient power to detect a modest treatment effect, and the fact that both treatment groups were given splints which may have accounted for the improvements seen.
A more recent study (Horng 2011) purports to show that tendon gliding exercises produce more improvement in hand function than nerve gliding exercises or splinting but again there are problems with the study including small size (20 patients per group), short follow up (8 weeks) poor blinding (neither patients nor those delivering the treatment blind to treatment allocation) and the fact that all three patient groups were treated with splinting and parrafin(wax) baths - a form of local heat treatment. A curious feature of this study is that the exercises involved are described and that the 'tendon gliding exercises' are in fact very similar to the 'nerve gliding exercises' - the principal difference being that the nerve version included some forced extension of the thumb. An alternative interpretation of their data might be that the nerve gliding exercises were actually detrimental.
Leaflets illustrating suitable exercises can be found at the Chartered Society of Physiotherapists website or in this leaflet from my own hospital physiotherapy department There are no good quality studies to show that such exercises actually help but they are unlikely to do any harm
Carpal Bone Mobilisation, Neurodynamic Mobilisation (Tal-Akabi 2000)
This study, which claims to support the use pf physiotherapy interventions for CTS, well illustrates the poor quality of much of the scientific literature. The study was carried out on only 21 patients who were divided into three groups - 7 untreated, 7 treated by 'neurodynamic mobilisation' and 7 by 'carpal bone mobilisation'. Neither the patients, nor the people delivering the treatment were blind to the treatment allocation. The investigators making the assessments of outcomes were apparently blind to the treatment allocation though this was not clearly stated in the original publication. Data from these tiny groups of patients was subjected to multiple statistical analyses on numerous different outcome measures, greatly increasing the risk that that one statistical test would come up 'positive' purely by chance. Only one statistically significant result is reported - better scores on a pain relief scale in the treatment groups, assessed using the Kruskal-Wallis statistical test. This test requires that the observations in the two groups being examined are drawn from populations with similarly shaped frequency distributions and this was not demonstrated in this paper - indeed it would be very hard to reliably assess the frequency distribution of these observations in samples of 7. This test is generally considered unreliable with sample sizes of less than 5 and samples of 7 leave little room for error. Like many others in the scientific literature these authors succumb to the temptation to report 'findings' which are not statistically significant but which they wish were true - to quote "In visual terms a clear trend was demonstrated between subjects who received treatment compared to those who were not treated, in particular the descriptive analysis of results for ULTT2a and numbers of patients continuing to surgery. " but the 'trend' was not statistically significant and a more truthful way of stating the findings here would be 'We could not show a difference between the treated and untreated groups except in one measure of pain relief'. Having said all that, there is one interesting observation here in that 6 of the 7 untreated patients went on to have surgery while only 3 of the 14 treated with physiotherapy did so. Unfortunately we do not know how long these subjects were followed up for - all the authors say is 'short term' and it is entirely possible that a few months of follow up might have changed these figures dramatically. A Cochrane review of this type of intervention is underway.
Closely related to this therapy are forms of massage of the wrist and forearm practiced by many physiotherapists but there are no satisfactory trials of such methods. You can also purchase a machine designed to apply this sort of massage automatically but again there is no published evidence of efficacy.
Yoga (Garfinkel 1998)
Randomised 26 patients to neutral angle wrist splinting and 25 to a programme of 'Yoga based' exercises - 60-90 minutes per session, twice weekly for 8 weeks - quite a demanding treatment programme. The Yoga group showed significant improvement in pain and grip strength over the course of treatment while the control group did not. Neither group showed any improvement in sleep disturbance or nerve conduction study results. The complete lack of response to splinting is a little odd but we are not told when patients were advised to use their splints and we have little idea of how severely affected the patients were. All we know is that they all had 'characteristic symptoms of CTS and abnormal nerve conduction studies'. Although the authors themselves described this as a 'preliminary' study it does not appear to have been followed up or repeated elsewhere.
Chiropractic manipulation (Davis 1998)
This study randomly allocated 91 patients with clinically diagnosed and neurophysiologically confirmed CTS to either splinting and analgesics OR splinting and analgesics plus chiropractic therapy and ultrasound therapy. The chiropractic consisted of manipulation of the soft tissues and bony joints of the upper limb and cervical spine for 16 sessions spread over 9 weeks and patients were followed up for a further month after finishing treatment. Both treatment groups improved and there was no detectable difference between them. The improvements may well have been entirely due to splinting.
Local ultrasound (Oztas 1998, Ebenbichler 1998, Koyuncu 1995)
Three trials of local ultrasound therapy for CTS have been considered methodologically good enough for inclusion in a meta-analysis by the Cochrane collaboration. The study by Ebenbichler et al was the largest (45 patients, 90 hands) and used the most intensive treatment regime (20 x 15 minute sessions of ultrasound spread over 7 weeks. Outcome measures were change in symptoms assessed using visual analog scales and change in nerve conduction measurements. 11 patients did not complete the treatment either because they could not manage to attend all the treatment sessions or because symptoms were worsening and required other interventions. 30 of the remaining 34 patients were followed up for 6 months. In each patient, one hand was given 'real' and one 'sham' ultrasound treatment. 23 out of 34 actively treated wrists had a satisfactory improvement in symptoms by the end of treatment compared to 13 out of 24 sham treated wrists. 22 out of 30 and 6 out of 30 were still in remission at 6 months follow up. Nerve conduction studies also improved significantly in the active but not the sham treated hands. In this study therefore the hands treated with ultrasound seemed to do better. The authors did not check how successful blinding had been. In contrast, smaller studies by Koyuncu et al (16 patients) and Oztas et al (18 patients), using less intensive treatment regimes failed to show any significant treatment response. This treatment modality seems worthy of further investigation though the exisiting evidence that ultrasound treatment has any effect on tissue other than a mild heating effect is somewhat doubtful.
Low level laser acupuncture (Branco 1999)
These authors tried low-level laser acupunture and microamps TENS treatment on 31 patients who MAY have had CTS. only 6 had nerve conduction studies to demonstrate a median nerve abnormality and 14 hands had previously had surgery for CTS either once or sometimes twice without benefit - rather suggesting that their problem might not have been CTS. Some of the patients were in addition given various Chinese herbal remedies so whether the results are telling us anything about laser acupuncture or microamps TENS is doubtful. There was no control group, no blinding of either patients or investigators, and the only outcome measure of any use was a pain score. The results claimed are significant pain reduction in 33 of 36 hands.
I would like to know the findings of this trial - but have been unable to find a published result as yet. Another trial is trying to compare acupuncture with oral carbamazepine. One study has been pubished comparing acupuncture with a short course of oral prednisolone (Yang 2009). Both groups seem to have improved to a more or less equal extent at 4 weeks but it is hard to draw any conclusions from this. The same patient cohort was followed up and a subsequent paper reported their outcomes after 1 year of follow up (Yang 2011). The acupuncture group seemed to do better in the longer follow-up also but as this was an unblinded study, in both reports, the findings should be treated with some caution. There is also now a systematic review of acupuncture for CTS (Sim 2011) which found a total of six trials for review, four of them from China. The methodological quality of the studies was judged to be poor and their conclusion in the summary was "The existing evidence is not convincing enough to suggest that acupuncture is an effective therapy for CTS". If one reads the article in full, in their discussion towards the end they phrase this rather differently, saying "...evidence of the effectiveness of acupuncture as a symptomatic treatment for CTS is encouraging but not convincing". The latter version, interestingly, is the one quoted by the British Acupuncture Council on their website. It seems clear that better quality trials are needed if we are ever to know for certain whether acupuncture is useful for CTS or not and until they are performed it is not possible to actively recommend this treatment.
...is a drug frequently used for nerve related pain and it might reasonably be expected to have some effect on pain occurring in carpal tunnel syndrome. A good quality randomised controlled clinical trial has now been completed and published (Hui 2011). 71 patients were given Gabapentin, aiming for a dose of 900mg daily and 69 were given a similar regimen of placebo. 8 patients withdrew from the placebo arm and 9 from the gabapentin arm because of side effects or lack of efficacy. The remainder were assessed at 8 weeks. Patients in both groups improved as assessed by a global symptom score, the improvements being similar. The conclusion is that Gabapentin is no more effective than placebo in treating CTS in the short term. It is notable that the symptomatic improvements in both groups over this short period of follow up were substantial - the global symptom score improving from 24 out of 50 to 13 out of 50 for example in the gabapentin group.
Another trial of Gabapentin was apparently carried out in Turkey (Arinci Incel N, Sezgin M, Aksit C, Sahin G. Effect of gabapentin in carpal tunnel syndrome: a controlled clinical trial [Karpal tunnel sendromunda gabapentin tedavisinin etkinligi: karsilastirmali klinik calisma]. Journal of Rheumatology and Medical Rehabilitation 2005;16(4):224-230.) but I have not seen this paper, which is presumably in Turkish - if anyone knows of it and would like to provide a translated copy that would be much appreciated.
Microamps TENS (Branco 1999, Naeser 2002)
For Branco see above. The study by Naeser is methodologically better. it was a single blind (the patients did not know whether they were getting real or sham treatment) randomised crossover trial (one in which all patients received both real and sham treatment in a random order) but was carried out on only 11 subjects so it is a very small study. The patients at least all had documented CTS based on both a clinical diagnosis and nerve conduction studies but again some had failed to respond to surgical treatment for CTS. As with the study by Branco microamps TENS was not the only intervention and various forms of acupuncture and laser application were also used. Subjects reported an improvement in pain scores after the real treatments but not after the sham ones. It is said that improvements in symptoms were maintained for 1-3 years of follow-up.
Cognitive behavioural therapy (Spence 1991)
This was a small study of 19 subjects with a variety of upper limb symptoms which had been attributed to occupational overuse. We do not know whether any of them actually had CTS. They were followed up 2 years after the course of therapy and compared with 14 patients drawn from a waiting list of subjects with similar problems but these waiting list controls did not include patients who had been on the waiting list for 2 years and the study is therefore actually comparing outcomes at 2 years after CBT with outcomes after 10 weeks of waiting. The treated patients seemed to do better on some measures but this study is probably telling us more about how people can be taught to cope with chronic symptoms than it is about treatment of CTS.
Hormone Replacement Therapy (Confino-Cohen 1991)
This report concerns only two female patients with CTS, one of whom had already failed to respond to carpal tunnel surgery on one hand. The main observation of interest is of relapses of symptoms each time the hormone replacement treatment was interrupted. No real conclusions can be drawn from two cases however.
Non-invasive laser neurolysis (Weintraub 1997)
An unblinded, uncontrolled study of laser application over the median nerve - the exact site of stimulation is not specified but treatment was delivered to 5 points for up to 15 treatment sessions. 30 hands in 23 patients were treated. 23 hands in 19 patients were said to recover completely. No further follow-up seems to have been carried out after completion of treatment and we do not know how long these improvements lasted.
A high quality trial of laser treatment has since been carried out (Irvine 2004) and found no difference between real and sham laser treatment. The treatment has also been assessed by the Blue Cross and Blue Shield/Kaiser Permanente health technology assessment programme who included four studies in their meta-analysis and concluded that there was inufficient quality evidence to draw any firm conclusion about the effectiveness of the treatment and on that basis it could not be recommended for routine use.
Either this or the 'low-level' laser used with acupuncture mentioned a few paragraphs above may be termed 'cold' laser therapy by practitioners and in adverts - the various terms are often not clearly defined. Another group has recently been promoting 'interferential' laser therapy, which sounds very scientific but is probably no different to any other laser variation.
Biofeedback (Thomas 1993)
This small study assessed whether EMG based biofeedback in a working environment on a production line had any effect on symptoms. It is by no means certain that the subjects actually had CTS but the intervention did not have any demonstrable effect anyway.
Ligament stretching devices (Porrata 2007)
One small uncontrolled study of this device has been published which suffers from some shortcomings. Most significantly it was carried out by the doctors who designed the C-trac device and who also market it themselves so that there is a clear conflict of interest. Having said that the trial results are interesting enough that this device deserves further study. The device is designed to apply traction along the length of the transverse carpal ligament in order to stretch it. The authors describe radologically visible widening of the carpal arch in two subjects while the device is in use but it is not clear whether this persists when the device is removed (as it does with surgery). The effect of application of the device on carpal tunnel pressure is unknown but one might wonder from a mechanical point of view whether it might be expected to increase it while being used. 19 patients were recruited all of whom had CTS as judged by clinical diagnosis and all of whom had abnormal nerve conduction studies as confirmation, though in one case from a long time before the study. All had tried conservative therapy with some combination of neutral angle wrist splinting, non-steroidal anti-inflammatory drugs, iontophoresis (with what?), stretching, moist heat, active and passive range of motion exercises, acupuncture, cortisone injections and massage. Oddly 18 of the 19 patients were said to have declined surgery when offered though the reasons are not stated. It is slightly unusual for patients with severe symptoms unresponsive to conservative measures to decline surgery and one of the inclusion criteria for this study was a high pain score on a visual analogue scale so one might suspect that there was something slightly atypical about this group of patients. They seem to have been highly motivated to avoid surgery in some way. All 19 patients reported a good response to treatment after 4 weeks and 16 out of 18 who were followed up for 7 months reported good results then also. 15 of them continued to use the device intermittently with varying frequency. Potential drawbacks to this device are cost ($299 in the USA originally, since reduced to about $150) and the inconvenience of the treatment schedule - the device was used three times daily for 5 minute sessions for 4 weeks initially and then as required afterwards - though this is only a little more onerous than conventional night splinting.
An independent trial of the C-trac device has now been completed and published by the Pulvertaft Hand Centre in Derbyshire (Storey 2013). They randomly allocated patients with mild to moderate CTS to treatment with either the C-trac or a conventional neutral angle wrist splint and assessed the outcomes at 8 weeks, six months and one year. 24 patients received the C-trac and 25 the conventional splint. No significant differences were detected in the effect on CTS symptoms and patient satisfaction at any of the three follow-up intervals. However the cost of treatment with C-trac, including replacement of worn out or faulty splints was £146.25 per patient compared to £13.20 per patient for the conventional splint. They also observed two examples of possible side-effects from the C-trac device (One case of de Quervain's tenosynovitis and one case of thumb base arthritic pain). Neither the patients nor the assessors were blind to treatment allocation and the severity of CTS was assessed in a relatively unsophisticated manner but nevertheless this trial provides a better assessment of this device than the manufacturers own data. I am pleased to see that the paper is available in full as a pdf file to the general public from the journal's website.
Pineapples have been recommended! (courtesy of a dietician writing in a newspaper - unsubstantiated by any evidence)
Insulin Injection at the carpal tunnel (Ozkul 2001, Ashraf 2008)
At first glance this appears a bizarre choice of intervention. The logic for giving insulin as a treatment for CTS is that it has been 'suggested' that insulin has an effect on nerve regeneration similar to that of nerve growth factor. 70 hands in 50 non-insulin dependent diabetic patients were randomly allocated to either insulin injection or physiotherapy. Two insulin injections were given two weeks apart and patients were then followed up for a further 4 weeks. Both groups of patients showed symptomatic and electrophysiological improvement but there was no difference in outcome between the two groups. The trial is described as 'single blind' but the method of blinding is uncertain - the patients themselves obviously knew whether they had injections or not. The authors conclusion that 'Local insulin injection is an effective and safe treatment for carpal tunnel syndrome in NIDDM patients as physiotherapy' is insupportable. All they have shown is that non-insulin dependent diabetic patients with CTS tend to improve if observed for a few weeks, not that either 'treatment' actually has an effect on carpal tunnel syndrome. This phenomenon is a common finding in observational studies of diseases which have a naturally relapsing and remitting course. Patients tend to turn up for treatment at a time when symptoms are severe, ie at a peak in the natural course of the disease, which will of course tend to be followed by a trough and improvement in symptoms whatever treatment is applied. This should be allowed for in short term clinical trials like this one by the inclusion of an untreated control group.
In a second paper (Ozkul) non-insulin dependet diabetic patients were treated with a moderate dose of steroid by injection (20mg methyprednisolone) followed by either a course of insulin injections or a course of placebo saline injections. The insulin group was suggested to do better on a subjective measure of symptom severity and some neurophysiological measures
Autologous blood injection (Jazayeri 2009)
Another proposed treatment based on flimsy logic - the authors suggesting that injecting a little of the patient's own blood into the carpal tunnel might 'provide the necessary cellular and humoral mediators to induce a healing cascade'. 20 patients were treated and assessed 3 weeks after injection. Their pain scores and nerve conduction measurements improved but there was no control group so this does not mean a lot.
The Iranian herb ‘bunge’ (Laciniata E.) applied as an ointment (Eftekharsadat 2010)
This herb is native to Iran, Turkey and Azerbaijan and is traditionally used as a local analgesic and anti-inflammatory agent. 40 patients with 60 affected hands were randomly alllocated to treatment with an ointment containing an extract of the herb or a placebo ointment. All patients were also treated with splinting and a conventional anti-inflammatory agent (sodium diclofenac) and were asked to rest the hands. All patients had clinically diagnosed CTS confirmed by nerve conduction studies but subjects with other coincident pathologies were excluded. Both patients and investigators were blind to treatment allocation and a variety of outcome measures were evaluated after 4 weeks of treatment. Both groups improved and on most outcome measures the improvement in the bunge group was no better or worse than that in the placebo group. On one measure of hand strength the active treatment group improved slightly more than the placebo group. The most interesting outcome measure was the use of a visual analog scale for severity of pain and tingling. Again both groups improved over the course of treatment. In the bunge group the change was from 6.53 to 4.33 (out of 10), while the placebo group improved from 5.16 to 4.63. This change in the placebo group was not statistically significant but the change in the active treatment group was significant (p<0.001) and was also significantly better than that in the placebo group (also p<0.001). No adverse effects of treatment were recorded. This result is sufficiently striking to be worth further investigation. One might express slight reservations over this study in that, the analysis was carried out by hand rather than by patient, and that the VAS scores in the placebo group before treatment were already lower than those in the active treatment group and the placebo group therefore had less 'room for improvement' to begin with. This trial should be repeated by other investigators but I am aware of no readily available source outside the Middle East for the ointment.
Lidocaine patches (Nalamachu 2006)
This unblinded study randomly allocated 20 patients each to treatment with either an injection of 40mg Depo-Medrol + lidocaine, or application of a lidocaine containing skin patch over the flexor aspect of the wrist for 4 weeks. Outcome assessment was focussed specifically on relief of pain, after 4 weeks of treatment. Both groups improved but the lidocaine patch group seemed to do rather better with 80% of the patch group reporting themselves 'satisfied' or 'very satisfied' with treatment compared to 59% of the injected group. A longer term follow-up of these patients would be desirable and a properly blinded trial could easily be devised. This article is freely available online - here
Traditional ‘Cupping’ (Michalsen 2009)
This was a randomised but unblinded trial of traditional 'cupping' vs local application of heat to the same treatment area (over the trapezius muscle at the shoulder). The 'wet-cupping' procedure used involves making multiple punctures in the skin with a lancet then applying vacuum suction to the area for either 5-10 minutes or until the therapist feels that enough blood has been withdrawn. Outcomes were assessed 7 days after a single treatment. Both treatment groups improved, the cupping group more so. This is a very short term study and is vulnerable to bias created by the lack of blinding.
EMLA cream (Moghtaderi 2009)
This trial compared 35 patients treated with a single steroid injection with 30 patients treated with EMLA cream (which contains a mixture of the two local anaesthetics lidocaine and prilocaine, 2.5% each) applied over the carpal tunnel for ten days. Both groups showed improvement in pain scores after 30 days. There was no blinding, no untreated control group, and the patients were apparently only asked about the effect on the single symptom of pain - neglecting any other symptoms of CTS. The conclusion drawn that EMLA cream is as effective as injection should be treated with some caution. 2 EMLA patients reported 'local adverse effects' - erythema and itching.
Static Magnet Therapy (Carter 2002, Colbert 2010)
Carter et al carried out quite a rigorous double blind, placebo controlled study of whether application of a magnet over the carpal tunnel acutely reduced reported pain during a 45 minute application period. They found no significant differences between the active and placebo groups. Colbert et al carried out a longer term randomised, doube blind, placebo controlled study in which 58 patients wore a magnet or a placebo metal disk on the wrist at night for 6 weeks. (One might wonder how successful the patient blinding was for this - it is a very simple matter to wave your 'magnet' near the fridge door to see if it sticks or not and 45% of the group given magnets reported either deliberately or accidentally discovering that their devices were magnetic). In any case no detectable differences in clinical or neurophysiological outcomes were found between the active and placebo groups. We thus have two methodologically fairly good studies suggesting that magnets do not have a dramatic effect on CTS. Even so, a further trial is in progress.
This is a topically applied ointment containing a complex cocktail of herbal extracts and vitamin B6 along with chemicals intended to promote absorbtion of these things through the skin. There appear to be no formal trials of this medication and no evidence that it is more effective than, say, massaging aqueous cream into the wrist several times a day.
Serratiopeptidase (Panagariya 1999)
This is a small (20 patients), unblinded, uncontrolled study of a novel drug for CTS. Serratiopeptidase is a proteolytic enzyme with significant anti-inflammatory and anti-edematous effects. The drug was given orally for 6 weeks, accompanied by another drug nimesulide for the first two weeks of treatment. Pain tingling and numbness improved over the course of treatment but in the absence of a control group it is hard to interpret this.
Progesterone Injection (Milani 2010, Ginanneschi 2012)
The Milani paper reported the design of a trial which was currently in progress. The plan was for 30 patients to be injected with cortisone and 30 with progesterone. Patients would be followed up for one year. A paper then appeared in 2012 with Dr Milani as one of the authors describing the results of what appears to be this trial, but in 8 patients per group and with only 6 months follow-up. It is not clear whether the trial is continuing to recruit to reach its original target or whether it has been stopped early.
This is a small pilot trial of local injection of the carpal tunnel with 17-hydroxy-progesterone caproate (17-HPC), a synthetic analogue of the naturally occurring female hormone progesterone. The logic behind this approach appears to have been experimental evidence that progesterone has an effect on pain sensation, possibly through direct actions on nerve function and repair after injury, rather than a belief that female hormones play a role in the causation of CTS. 8 women with mild CTS in each group received an injection of either 85mg 17-HPC or 20mg of triamcinolone acetate, a synthetic steroid into one hand. The injections were placed in the carpal tunnel under ultrasound guidance and outcomes were assessed using the Boston/Levine subjective severity scores (SSS and FSS), neurophysiological measures, ultrasound imaging and a visual analog pain scale (VAS) at baseline and one and six months after injection. Blinding of the patients, treating doctor and observers is poorly described but otherwise this is a meticulously performed small study.
I have some reservations about the statistics which were performed on the results because the study groups were so small. The results are complex because so many different evaluations were performed. In terms of subjective response both the steroid and progesterone groups improved one month after injection on the SSS. At 6 months there was evidence of relapse of the steroid group but improvement in the progesterone group seemed to be maintained. Changes in the FSS were unimpressive but these were patients with mild CTS and quite low FSS scores to start off with – so not a lot of room for improvement. The VAS improved dramatically in both groups at 1 month and this improvement was sustained at 6 months in the progesterone group but not the steroid group in whom pain recurred at 6 months. This is in keeping with the relapse seen in the SSS score – several of the questions in the SSS are about pain. The neurophysiological studies appeared to show slight improvement in sensory conduction in the steroid group only but again I have reservations about the statistics of this. On the ultrasound imaging the progesterone group showed no significant changes while the steroid group improved at one month and relapsed at 6 months.
Taken at face value then, these results suggest that that the progesterone analog, given as a single dose (which would have been gone from the injection site within a few days) produced a subjective improvement in symptoms lasting 6 months without having any great effect on either the structure (ultrasound) or measurable function (neurophysiology) of the median nerve. In contrast, the admittedly fairly small dose of triamcinolone produced an improvement in all measures which lasted only for a month. The progesterone response is hard to explain on the basis of a pharmacological effect of the drug on nerve function because it was so sustained over time. The authors discuss this possible mechanism at some length but it seems unlikely that the mechanisms they describe could have been acting at 6 months. They also discuss the possibility that progesterone may promote the regrowth and repair of small nerve fibres and this could perhaps have some relevance to the prolonged effect but at present there is little evidence that small nerve fibres have actually degenerated in very early carpal tunnel syndrome so this requires more work.
... are marketed for treatment of CTS and a wide variety of other disorders. It may well make hands feel better if you keep them warm but I can find no satisfactory published scientific evidence that these have any special merit in treating CTS.
The makers of this hand-held gyroscope which is used to exercise the forearm claim that it can help CTS sufferers but produce no scientific evidence in support.
Botulinum Toxin (Tsai 2006)
This small unblinded, uncontrolled, pilot trial treated 5 patients with one injection of 60 units of botulinum toxin and followed them up for 3 months. Pain improved in 3 patients, stayed the same in one and got worse in one. Given the tendency of all patients enrolled in any trial of CTS treatment to improve over this sort of time period, concluding that botox is effective for treating CTS is not warranted. A better trial is in progress.
Ischaemic Compression Therapy (Hains 2010)
This treatment consists of manual pressure applied with the thumb to multiple 'trigger points' along the course of the median nerve through the axilla, upper arm and proximal forearm. Pressure is applied for 5-15 seconds at each point, gradually increasing until reaching the patient's maximum pain tolerance level. 37 patients were treated in this way and 18 patients had similar pressure applied to different sites around the shoulder not thought to be involved with the median nerve. 13 of these control patients subsequently crossed over to the experimental treatment. Results are oddly reported - they appear to have combined the Boston/Levine symptom severity and functional impairment scores into a single overall score rather than reporting them separately and they also used another 'perceived improvement numerical scale'. Both measures showed a modest difference in favour of the active treatment after 15 sessions of treatment but it was not possible to compare after longer periods because the control group were then treated. The patients appear to have been at least partially blinded to which treatment they were receiving - though they clearly knew which part of the limb was being manipulated and it is possible that manipulation of the arm may have made 'more sense' to them than manipulation of the shoulder as a treatment for CTS. The therapists were clearly not blind to treatment allocation and were a potential source of bias.
Therapeutic Touch (Blankfield 2001)
11 patients were treated with therapeutic touch and 10 with sham therapeutic touch. The difference between the two treatments appears to have been what the therapist was thinking about while touching the patient - either 'focusing on the patient with intent for wellness' in the case of the active group or counting backwards from 100 to 1 repeatedly for the sham treatment. No differences in outcome between the two groups were observed in any subjective or neurophysiological measure (rather poor and unblinded neurophysiology) but all of the subjects improved anyway.
Oscillatory Biofield Therapy (Nourbakhsh 2016)
This appears to be a much more 'sciencey' sounding name for therapeutic touch which is why I have placed it here. it is claimed that practitoners can voluntarily influence magnetic fields by thought and claims have been made that these changes in magnetic fields can be measured with conventional magnetometers (Moga 2014). Before we look at the study by Nourbakhsh et al it is worth examining this claim somewhat. Moga measured magnetic field strength in the area of a treatment table:- a) with a healer and a patient engaged in healing, b) with a patient relaxing while listening to a relaxation tape on headphones and c) with only the healer present trying to heal an imaginary patient. All of these recordings show small variations in the strength of the magnetic fields recorded all the time and this is a common feature of magnetometer readings - the earth's magnetic field shows natural variations. The findings of this study consist of reported changes in the size of these variations. To understand this further we need to know something about magnetic field strength. This is measured in two different units (Tesla and Gauss) but for ease here I am going to convert all of these measurements to nanoTesla - (1 nT = 10-9 Tesla or 1000 millionth of 1 Tesla). The earth's magnetic field varies from place to place and ranges from 20,000 to 80,000 nT. A small bar magnet can easily have a field strength of 10 million nT. Superimposed on this baseline field strength the natural oscillations of the earth's field are generally about 100 nT. The change in size of the oscillations recorded by Moga when the healers began work was from about 30 nT to 45 nT - a change of, if we are generous, about 20 nT. The oscillations seen in the relaxing patients were higher, about 40 nT at baseline, but did not vary during the session. Curiously the mean results found during the 'mock' healing situation (c) are not reported in the paper - though some example recordings are shown. It is hard to know what to make of this. The physical phenomena being measured are extremely small variations in magnetic fields and we are all exposed to both far stronger baseline magnetic fields and constant minor oscillations of field strength of the same order of magnitude as these supposed 'therapeutic' fields merely by virtue of the fact that we live on Earth so presumably we are all being 'healed' all the time. This seems to be a case of a fundamentally implausible treatment so it calls for extraordinary evidence to demonstrate that it works.
Nourbakhsh et at took thirty patients with "chronic carpal tunnel syndrome" Most of these had been given a medical diagnosis of CTS but this had not been confirmed with nerve conduction studies. Interestingly most were said to have had previous unsuccessful treatments for CTS such as splints or steroid injections - which makes them an unusual group of patients compared to the average CTS case. Subjects were randomly allocated to 'active' or 'pretend' treatment - the difference between the two again being esentially the intent of the practitioner delivering the treatment. It is at this point that I have to criticise the description of this study in the title as 'double-blind'. In a truly blinded study the patients, therapists and assesors are all unaware of the treatment allocation until all follow-up is complete and the results of treatment have been assessed. In this case the therapist HAD to know the treatment allocation and it seems very possible that this knowledge was communicated to the subjects, even if unconsciously. The results are dramatic. The actively treated group did much better on every subjective measure of outcome (SSS, FSS, DASH score, Pain score) - ie all the things which rely on the subjective report of symptoms from the patient. There were no significant differences in the groups on objective measures of grip and pinch strength or sensation (2-point discrimination and Semmes Weinstein monfilament testing). Notwithstanding these reservations the change in SSS in the treatment group was from a mean score of 2.6 to 1.6 - a whole unit change which is similar to that achieved by corticosteroid injection and only a little less that the average change with surgery. It was also claimed that this improvement was maintained for six months. This treatment should be tested again with a more rigorous blinding protocol and a better chosen patient group.
Aerobic Exercise (Nathan 2001)
In an uncontrolled study, Nathan et al looked at whether 10 months of an aerobic exercise programme, with a concomitant increase in general fitness, would have any impact on carpal tunnel syndrome. The 30 subjects did get fitter (their body mass index decreased, ie they lost weight, and peak oxygen consumption improved) and their median nerve sensory conduction improved but there were no significant changes in CTS symptoms (except when both hands of each patient were counted separately - a statistically dubious manoever)
Sonographically guided percutaneous needle release (McShane 2012)
This approach tries to alleviate CTS by injecting saline and local anaesthetic between the median nerve and transverse carpal ligament and then repeatedly perforating the ligament with a somewhat larger needle in a proximal to distal direction, parallel to the median nerve. In this study 18 of 36 potentially eligible patients provided at least some follow-up data and 15 of these said they would recommend the procedure to others. This is not a very satisfactory study for many reasons but the most telling item is that the final stage of the treatment was the instillation of a large dose of betamethasone (20mg, roughly equivalent to 120mg of triamcinolone - we usually use 40mg of triamcinolone for injection) into the transverse carpal ligament. It is therefore likely that this study is mostly showing the effect of steroid treatment and the complex procedure with the needles and ultrasound scanner may have been irrelevant.
ESWT - Extracorporeal Shockwave Therapy (Seok 2014)
This treatment - better known for 'disintegrating' kidney stones uses high powered ultrasound waves to apply energy to tissue in a focussed manner. This small unblinded trial compared applying this treatment to the wrist for about 3 minutes in 15 patients with mild to moderate CTS with the alternative of steroid injection with 40mg triamcinolone in 16 patients. No proper control group was used. Both treatment groups showed significant improvement in symptoms at 3 months after treatment but only the injected group showed significant improvement in nerve conduction measurements. No firm conclusions can be drawn from this trial.
Revision date - 20th August 2016