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NMES and Pelvic Fracture Rehabilitation

The Use of Neuromuscular Electrical Stimulation With Pelvic Fracture Rehabilitation: A Randomised, Double Blind, Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03278834
Enrollment
9
Registered
2017-09-12
Start date
2014-01-01
Completion date
2014-06-01
Last updated
2017-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rehabilitation, Trauma

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).

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.

Sponsors

Barts & The London NHS Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Treatment and intervention group

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

*

Design outcomes

Primary

MeasureTime frameDescription
Muscle Strength12 weeks post operationPeak Torque muscle strength

Secondary

MeasureTime frameDescription
Feasibility questionnaire12 weeks post operationquestionnaire of 10 questions

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026