NMES and Pelvic Fracture Rehabilitation

September 8, 2017 updated by: Barts & The London NHS Trust

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: Neuromuscular muscle stimulation machine- Strength Setting
Muscle stimulation to strength skeletal muscle
PLACEBO_COMPARATOR: 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.
Device: Neuromuscular muscle stimulation machine - TENS Setting
Muscle stimulation to mimic the intervention but without the strength gains.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

July 13, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (ACTUAL)

September 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMES Pilot Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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