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NMES and Pelvic Fracture Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278834
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust

Tracking Information
First Submitted Date  ICMJE July 13, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date September 12, 2017
Actual Study Start Date  ICMJE January 1, 2014
Actual Primary Completion Date June 1, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
Muscle Strength [ Time Frame: 12 weeks post operation ]
Peak Torque muscle strength
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
Feasibility questionnaire [ Time Frame: 12 weeks post operation ]
questionnaire of 10 questions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NMES and Pelvic Fracture Rehabilitation
Official Title  ICMJE The Use of Neuromuscular Electrical Stimulation With Pelvic Fracture Rehabilitation: A Randomised, Double Blind, Pilot Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
Treatment and intervention group
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Trauma
  • Rehabilitation
Intervention  ICMJE
  • Device: Neuromuscular muscle stimulation machine- Strength Setting
    Muscle stimulation to strength skeletal muscle
  • Device: Neuromuscular muscle stimulation machine - TENS Setting
    Muscle stimulation to mimic the intervention but without the strength gains.
Study Arms  ICMJE
  • 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.

    Intervention: Device: Neuromuscular muscle stimulation machine- Strength Setting
  • 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.

    Intervention: Device: Neuromuscular muscle stimulation machine - TENS Setting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2017)
9
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2014
Actual Primary Completion Date June 1, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03278834
Other Study ID Numbers  ICMJE NMES Pilot Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barts & The London NHS Trust
Study Sponsor  ICMJE Barts & The London NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Barts & The London NHS Trust
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP