CClinicalTrials.gg
CompletedNCT03278834Updated Sep 12, 2017

NMES and Pelvic Fracture Rehabilitation

An interventional study of Neuromuscular muscle stimulation machine- Strength Setting and Neuromuscular muscle stimulation machine - TENS Setting in Trauma and Rehabilitation, sponsored by Barts & The London NHS Trust. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-12.

Sponsored by Barts & The London NHS Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Trauma
  • Rehabilitation

Browse trials for

03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
9 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceNeuromuscular muscle stimulation machine- Strength Setting

    Muscle stimulation to strength skeletal muscle

  • DeviceNeuromuscular muscle stimulation machine - TENS Setting

    Muscle stimulation to mimic the intervention but without the strength gains.

05

What researchers measure

Primary outcomes

  1. Muscle Strength

    Peak Torque muscle strength

    Time frame: 12 weeks post operation

Secondary outcomes

  1. Feasibility questionnaire

    questionnaire of 10 questions

    Time frame: 12 weeks post operation

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03278834
Lead sponsor
Barts & The London NHS Trust
Responsible party
Sponsor
First posted
Sep 12, 2017
Start date
Jan 1, 2014
Primary completion
Jun 1, 2014
Completion
Jun 1, 2014
Last update
Sep 12, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion