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NMES and Pelvic Fracture Rehabilitation

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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

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).


Condition or disease Intervention/treatment Phase
Trauma Rehabilitation Device: Neuromuscular muscle stimulation machine- Strength Setting Device: Neuromuscular muscle stimulation machine - TENS Setting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Treatment and intervention group
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Neuromuscular Electrical Stimulation With Pelvic Fracture Rehabilitation: A Randomised, Double Blind, Pilot Study
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : June 1, 2014
Actual Study Completion Date : June 1, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Device: Neuromuscular muscle stimulation machine- Strength Setting
Muscle stimulation to strength skeletal muscle

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.

Device: Neuromuscular muscle stimulation machine - TENS Setting
Muscle stimulation to mimic the intervention but without the strength gains.




Primary Outcome Measures :
  1. Muscle Strength [ Time Frame: 12 weeks post operation ]
    Peak Torque muscle strength


Secondary Outcome Measures :
  1. Feasibility questionnaire [ Time Frame: 12 weeks post operation ]
    questionnaire of 10 questions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT03278834    
Other Study ID Numbers: NMES Pilot Study
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries