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NMES and Pelvic Fracture Rehabilitation

Primary Purpose

Trauma, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuromuscular muscle stimulation machine- Strength Setting
Neuromuscular muscle stimulation machine - TENS Setting
Sponsored by
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention Group

    Placebo Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Muscle Strength
    Peak Torque muscle strength

    Secondary Outcome Measures

    Feasibility questionnaire
    questionnaire of 10 questions

    Full Information

    First Posted
    July 13, 2017
    Last Updated
    September 8, 2017
    Sponsor
    Barts & The London NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03278834
    Brief Title
    NMES and Pelvic Fracture Rehabilitation
    Official Title
    The Use of Neuromuscular Electrical Stimulation With Pelvic Fracture Rehabilitation: A Randomised, Double Blind, Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    June 1, 2014 (Actual)
    Study Completion Date
    June 1, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Barts & The London NHS Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trauma, Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    Treatment and intervention group
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Neuromuscular muscle stimulation machine- Strength Setting
    Intervention Description
    Muscle stimulation to strength skeletal muscle
    Intervention Type
    Device
    Intervention Name(s)
    Neuromuscular muscle stimulation machine - TENS Setting
    Intervention Description
    Muscle stimulation to mimic the intervention but without the strength gains.
    Primary Outcome Measure Information:
    Title
    Muscle Strength
    Description
    Peak Torque muscle strength
    Time Frame
    12 weeks post operation
    Secondary Outcome Measure Information:
    Title
    Feasibility questionnaire
    Description
    questionnaire of 10 questions
    Time Frame
    12 weeks post operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    NMES and Pelvic Fracture Rehabilitation

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