NMES and Pelvic Fracture Rehabilitation

Study Overview
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Brief Summary
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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).

Official Title
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The Use of Neuromuscular Electrical Stimulation With Pelvic Fracture Rehabilitation: A Randomised, Double Blind, Pilot Study

Conditions
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Trauma, Rehabilitation

Intervention / Treatment
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* Device: Neuromuscular muscle stimulation machine- Strength Setting
* Device: Neuromuscular muscle stimulation machine - TENS Setting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Treatment and intervention group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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. | Device: Neuromuscular muscle stimulation machine- Strength Setting<br>* Muscle stimulation to strength skeletal muscle<br>|
| Placebo Comparator: Placebo Group<br>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. | Device: Neuromuscular muscle stimulation machine - TENS Setting<br>* Muscle stimulation to mimic the intervention but without the strength gains.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength | Peak Torque muscle strength | 12 weeks post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility questionnaire | questionnaire of 10 questions | 12 weeks post operation |