The Use of Neuromuscular Electrical Muscle Stimulation With Pelvic Fracture Rehabilitation: A Double Blind, Placebo Controlled, Randomised Control Trial

All subjects who wish to enter the study will be fully screened and consented by the Chief Investigator, or an appropriate delegate. The Royal London is the largest major trauma centre in London and fixes more pelvic fractures than any other hospital. The orthopedic team will surgically fix between two and six pelvic fractures per week which should meet the inclusion criteria. Pelvic fractures are surgically fixed and then will be instructed to put no weight through the operated limb for 10-12 weeks by the orthopedic consultant. The physiotherapist will give the patient a bed exercise programme day one post operation as per standard practice which consists of hip range of movement exercises and gentle strengthening exercises for muscles around the hip and thigh.

The chief investigator will be part of the patient's normal healthcare team and will identify eligible participants. The participants will be recruited one week post operation to give the patient time to recover from their surgery but not allow for loss in muscle mass. The research assistant will approach the participant 24 hours prior to this and explain the demands of the study and what it will involve allowing the participant 24 hours to discuss this with family members.

After the 24 hour period the chief investigator will also be present to answer any questions about the study. The participant will be expected to provide written informed consent and will be expected to sign the treatment contract which outlines the responsibilities of the participant and the chief investigator. On discharge a six week follow up appointment in fracture clinic will be arranged in which both the consultant and chief investigator will be present to complete the EQ5D questionnaire and monitor compliance within the first six weeks of the intervention. At 10 weeks the participant will have a further fracture clinic appointment in which they are expected to bring back the machine and make a short journey to the human performance laboratory and Queen Mary's University to complete their gait analysis and strength testing along with a further EQ5D questionnaire, this will be the end of the study and the participants are free to leave.

Randomisation procedure

Simple random sampling will be used with a free randomisation computer programme (www.sealedenvelopes.co.uk). When the patient has consented to the study the chief investigator will enter the participant unique study number into the website whilst the participant can read the patient information sheet and treatment contract and it will randomly allocate into treatment (NMES) or placebo (TENS) group. If a participant withdrew from the study a new participant could not replace this participant but be randomly allocated into a group as a new patient.