NMES and Pelvic Fracture Rehabilitation

Barts & The London NHS Trust

Status: Completed

Conditions: Rehabilitation; Trauma

Treatments: Device: Neuromuscular muscle stimulation machine- Strength Setting; Device: Neuromuscular muscle stimulation machine - TENS Setting

Study type: Interventional

Funder types: Other

Identifiers

NCT03278834

NMES Pilot Study

Details and patient eligibility

About

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).

Enrollment: 9 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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9 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

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.

Treatment:

Device: Neuromuscular muscle stimulation machine- Strength Setting

Placebo Group

Placebo Comparator group

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.

Treatment:

Device: Neuromuscular muscle stimulation machine - TENS Setting