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
About this trial
This is an interventional treatment trial for Trauma
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.
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
NCT ID
NCT03278834
First Posted
July 13, 2017
Last Updated
September 8, 2017
Sponsor
Barts & The London NHS Trust
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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