However, the reduction in frequency was significantly greater in the experimental PI3K inhibitor group, by a mean of 1.2 cramps per night (95% CI 0.6 to 1.8). The severity of nocturnal leg cramps did not improve at all in the control group. However, there was a substantial reduction in the experimental group. The mean difference in improvement in the severity of the nocturnal leg cramps was

1.3 cm on the 10-cm visual analogue scale. No adverse events were reported in either group. Our results showed that six weeks of nightly stretching of the calf and hamstring muscles significantly reduced the frequency and severity of nocturnal leg cramps in older people. The best estimate of the average effect of stretching on the frequency of cramps was a reduction of about one cramp per night. Given that participants had an average of approximately three cramps per night at the beginning of the study, this is a substantial effect and approximately equal to the effect we nominated as worthwhile. Since the stretches are quick and simple to perform, some patients may even consider the weakest effect suggested by Capmatinib price the limit of the confidence interval (a reduction of 0.6 cramps per night) to be worthwhile. The stretches reduced the severity

of the pain that occurred with the nocturnal leg cramps by 1.3 cm on a 10-cm visual analogue scale. We do not know the smallest effect on the severity of the cramps that patients typically feel would make the stretches worthwhile. In other research using the 10-cm visual analogue scale for pain, a change score of 2 cm has been proposed in chronic low back pain patients (Ostelo and de Vet, 2005). An effect of this magnitude was not achieved in our study within the 6-week intervention period. However, the confidence interval around this result is reasonably

narrow. Therefore patients can be advised that the average effect of the stretches is to reduce the severity of the pain by 1.3 cm on the 10-cm scale (or close to this value). Patients can then decide for themselves whether this effect – in addition to the reduced whatever frequency of the cramps – makes the stretches worth doing. In this trial, stretching was performed at home and was patient-centred. This facilitated performance of the intervention, which may have aided adherence with the stretches and increased the effectiveness of the intervention. In this setting, however, correct execution of the stretching technique was not closely monitored. All the participants in the experimental group did two exercises, regardless of whether the cramp was located in the hamstrings or calf. Greater effects may perhaps be achievable if stretches were to be targeted at the site(s) of each participant’s cramps. This could be investigated in a future trial.