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OpenTrials
Completed

NCT Number: NCT03278834

NMES and Pelvic Fracture Rehabilitation

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).

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Key information

Conditions

Trauma Rehabilitation Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neuromuscular muscle stimulation machine- Strength Setting

Device

Muscle stimulation to strength skeletal muscle

Neuromuscular muscle stimulation machine - TENS Setting

Device

Muscle stimulation to mimic the intervention but without the strength gains.

Primary outcomes

  1. Muscle Strength

    Time frame: 12 weeks post operation

    Peak Torque muscle strength

Secondary outcomes

  1. Feasibility questionnaire

    Time frame: 12 weeks post operation

    questionnaire of 10 questions

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 12, 2017
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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