The Use of Neuromuscular Electrical Muscle Stimulation With Pelvic Fracture Rehabilitation: A Double Blind, Placebo Controlled, Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Muscle strength in peak torque between treatment and placebo group
研究概览
简要总结
The purpose of the study is to investigate if using an electrical stimulation machine to see if it can help strengthen the muscles around the hip during the first three months post pelvic fracture will help with the early stages of rehabilitation. Electrical stimulation is a treatment machine that uses an electrical current to cause a single muscle or a group of muscles to contract. This contraction helps strengthen injured muscles and helps with the healing process. It can also help with pain relief by blocking pain signals from the brain.
After a pelvic fracture they are surgically fixed and will be advised not to put any weight on the operated leg for 10 weeks. During this time hip muscles become very weak as they will not be used as much as normal. Bed exercises can help keep muscle strength but this study would like to try using electrical stimulation machines alongside bed exercises to see if it can improve muscle strength even more. Electrical stimulation machines are already used by rehabilitation. Electrical stimulation is a treatment machine that uses an electrical current to cause a single muscle or a group of muscles to contract. This contraction helps strengthen injured muscles and helps with the healing process. It can also help with pain relief by blocking pain signals from the brain.
After a pelvic fracture they are surgically fixed and will be advised not to put any weight on the operated leg for 10 weeks. During this time hip muscles become very weak as they will not be used as much as normal. Bed exercises can help keep muscle strength but this study would like to try using electrical stimulation machines alongside bed exercises to see if it can improve muscle strength even more. Electrical stimulation machines are already used by patients to increase muscle strength.
Participants will be put into one of two groups, both groups will be given an electrical stimulation machine but one will be on a placebo setting. Participants will need to use the machine twice a day along with their bed exercises and will need to fill in a diary when and how many times the machine has been used for 10 weeks until their 12 week appointment with the orthopaedic consultant. The participants weight bearing status will change and they will be asked to perform a muscle strength test on both the operated and nonoperated leg. They will also have their walking quality assessed. The results will compare both groups for muscle strength and walking changes.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who can give written informed consent
- •Patients with surgically fixed pelvic fractures who are TTWB for up to 10-12 weeks
- •Patients with associated injuries considered for example fractured upper limb however their recovery must be within six weeks when they start the intervention.
- •Males and females between 18-70 years old
- •Patients able to comply and complete the electrical stimulation machine and complete both bed exercises and NMES twice daily.
排除标准
- •Patients with current or previous mental health, chronic pain or previous injury which may affect participation.
- •Any complex lower limb injury in either limb unless fixed and cleared six weeks post injury.
- •Severe kidney injuries which are ongoing will not considered following a case of rhabdomyolysis induced by excessive NMES (Guarascio et al, 2004).
- •Patients who may be pregnant
- •Patients who suffer from sensitivity problems for the skin
- •Patients who may have an abdominal or Inguinal hernia
- •Patients with arterial circulation disorders of the lower limb
- •Patients with pacemakers
研究组 & 干预措施
Treatment NMES
Patients allocated to the NMES group will be given an information booklet on NMES machines. The Cefar Compex three electrical stimulator will be used. Participants are expected to use the NMES machine for half an hour and complete bed exercises twice daily. Patients should relax during the NMES as completing both does not demonstrate better results, due to unsynchronised activation of the NMES (Gregory & Bickel, 2005). Using the machine once daily will allow for the recovery of the muscle. A voluntary contraction would normally be 20-30Hz but due to the high intensities of the NMES (35-75Hz) it can cause muscle fatigue (Maffiuletti, 2011).
干预措施: Treatment NMES (Device)
Placebo NMES
The placebo group will act as the control group. They will be expected to complete the same regime as previously described above, however these machines will be on TENS setting (80-100Hz) as even low Hz can trigger motor stimulation (Paillard 2008). This setting is designed as a sensory stimulus therefore will have no effects on muscle strength however the patient will feel a small twitch sensation. This setting is not painful and will have no effect on muscle fatigue. The patient will not be expected to complete the bed exercises and the TENS session together.
干预措施: Placebo NMES (Device)
结局指标
主要结局
Muscle strength in peak torque between treatment and placebo group
时间窗: 10 weeks
HUMAC isokinetic machine
次要结局
- EQ5D questionnarrie(10 weeks)
- Gait analysis(10 weeks)