NMES and Pelvic Fracture Rehabilitation

Not Applicable

Completed

• Conditions: Trauma; Rehabilitation
• Interventions: Device: Neuromuscular muscle stimulation machine- Strength Setting; Device: Neuromuscular muscle stimulation machine - TENS Setting

• Registration Number: NCT03278834
• Lead Sponsor: Barts & The London NHS Trust

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2014-06-01
• Study Completion: 2014-06-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-09-08
• Last Update Submitted: 2017-09-08
• Study First Posted: 2017-09-12
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Neuromuscular muscle stimulation machine- Strength Setting	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.
Placebo Group	Neuromuscular muscle stimulation machine - TENS Setting	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.

Primary Outcome Measures

Name	Time	Method
Muscle Strength	12 weeks post operation	Peak Torque muscle strength

Secondary Outcome Measures

Name	Time	Method
Feasibility questionnaire	12 weeks post operation	questionnaire of 10 questions