The Use of Neuromuscular Electrical Stimulation With Pelvic Fracture Rehabilitation: A Randomised, Double Blind, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- Muscle Strength
研究概览
简要总结
Objectives: The acute care of pelvic fractures has improved recently however there are no formal guidelines for rehabilitation of these types of fractures. Patients have long periods of non-weight bearing causing muscle wastage. Neuromuscular electrical stimulation (NMES) has proven to minimise muscle loss. However, this has not previously been investigated within this patient population.
Design: Double blind, randomised, feasibility study.
Setting: NHS trust hospital setting.
Participants: Nine patients with surgically fixed pelvic fractures were randomly allocated at six weeks post fracture.
Interventions: The intervention group completed six weeks of NMES. The placebo group used transcutaneous electrical nerve stimulation (TENS).
Main outcome measures: Peak torque (Nm) was calculated in the operated limb at 12 weeks using the non-operated limb as a baseline. Compliance and intensity levels were recorded. Feasibility of NMES was evaluated using a feasibility questionnaire. Pain was measured at six and 12 weeks using a visual analogue scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria were any patient with a pelvic fracture that was surgically fixed with no associated injuries and able to give written informed consent.
- •Pelvic fractures including acetabular and pelvic ring fracture that were fixed using open reduction internal fixation (ORIF) were considered.
排除标准
- •Exclusion criteria were patients who could not comply with the NMES or who had previous mental health diagnosis.
- •Patients who may be pregnant, have severe kidney injury or have a pacemaker were excluded.
研究组 & 干预措施
Intervention Group
Neuromuscular muscle stimulation machine - Muscle stimulation machine to be used on glutes and abductors on disuse atrophy setting.
Twice per day for 45 minutes.
Exercise - Home exercises programme once per day with 10 exercises.
干预措施: Neuromuscular muscle stimulation machine- Strength Setting (Device)
Placebo Group
Neuromuscular muscle stimulation- Muscle stimulation machine to be used on glutes and abductors on TENS setting. Twice per day for 45 minutes.
Exercise - Home exercises programme once per day with 10 exercises.
干预措施: Neuromuscular muscle stimulation machine - TENS Setting (Device)
结局指标
主要结局
Muscle Strength
时间窗: 12 weeks post operation
Peak Torque muscle strength
次要结局
- Feasibility questionnaire(12 weeks post operation)