<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03278834</url>
  </required_header>
  <id_info>
    <org_study_id>NMES Pilot Study</org_study_id>
    <nct_id>NCT03278834</nct_id>
  </id_info>
  <brief_title>NMES and Pelvic Fracture Rehabilitation</brief_title>
  <official_title>The Use of Neuromuscular Electrical Stimulation With Pelvic Fracture Rehabilitation: A Randomised, Double Blind, Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barts &amp; The London NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barts &amp; The London NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: The acute care of pelvic fractures has improved recently however there are no&#xD;
      formal guidelines for rehabilitation of these types of fractures. Patients have long periods&#xD;
      of non-weight bearing causing muscle wastage. Neuromuscular electrical stimulation (NMES) has&#xD;
      proven to minimise muscle loss. However, this has not previously been investigated within&#xD;
      this patient population.&#xD;
&#xD;
      Design: Double blind, randomised, feasibility study.&#xD;
&#xD;
      Setting: NHS trust hospital setting.&#xD;
&#xD;
      Participants: Nine patients with surgically fixed pelvic fractures were randomly allocated at&#xD;
      six weeks post fracture.&#xD;
&#xD;
      Interventions: The intervention group completed six weeks of NMES. The placebo group used&#xD;
      transcutaneous electrical nerve stimulation (TENS).&#xD;
&#xD;
      Main outcome measures: Peak torque (Nm) was calculated in the operated limb at 12 weeks using&#xD;
      the non-operated limb as a baseline. Compliance and intensity levels were recorded.&#xD;
      Feasibility of NMES was evaluated using a feasibility questionnaire. Pain was measured at six&#xD;
      and 12 weeks using a visual analogue scale (VAS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">June 1, 2014</completion_date>
  <primary_completion_date type="Actual">June 1, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Treatment and intervention group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>12 weeks post operation</time_frame>
    <description>Peak Torque muscle strength</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility questionnaire</measure>
    <time_frame>12 weeks post operation</time_frame>
    <description>questionnaire of 10 questions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Trauma</condition>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neuromuscular muscle stimulation machine - Muscle stimulation machine to be used on glutes and abductors on disuse atrophy setting.&#xD;
Twice per day for 45 minutes.&#xD;
Exercise - Home exercises programme once per day with 10 exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Neuromuscular muscle stimulation- Muscle stimulation machine to be used on glutes and abductors on TENS setting. Twice per day for 45 minutes.&#xD;
Exercise - Home exercises programme once per day with 10 exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuromuscular muscle stimulation machine- Strength Setting</intervention_name>
    <description>Muscle stimulation to strength skeletal muscle</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuromuscular muscle stimulation machine - TENS Setting</intervention_name>
    <description>Muscle stimulation to mimic the intervention but without the strength gains.</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria were any patient with a pelvic fracture that was surgically fixed&#xD;
             with no associated injuries and able to give written informed consent.&#xD;
&#xD;
          -  Pelvic fractures including acetabular and pelvic ring fracture that were fixed using&#xD;
             open reduction internal fixation (ORIF) were considered.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria were patients who could not comply with the NMES or who had&#xD;
             previous mental health diagnosis.&#xD;
&#xD;
          -  Patients who may be pregnant, have severe kidney injury or have a pacemaker were&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03278834
org study id: NMES Pilot Study
nct id: NCT03278834
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Treatment and intervention group
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Muscle Strength
time frame: 12 weeks post operation
description: Peak Torque muscle strength
measure: Feasibility questionnaire
time frame: 12 weeks post operation
description: questionnaire of 10 questions
arm group label: Intervention Group
arm group type: Experimental
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 group label: Placebo Group
arm group type: Placebo Comparator
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: Neuromuscular muscle stimulation machine- Strength Setting
description: Muscle stimulation to strength skeletal muscle
arm group label: Intervention Group
intervention type: Device
intervention name: Neuromuscular muscle stimulation machine - TENS Setting
description: Muscle stimulation to mimic the intervention but without the strength gains.
arm group label: Placebo Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Hip Fractures