NMES and Pelvic Fracture Rehabilitation

NCT ID: NCT03278834

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2014-06-01

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).

Conditions

Trauma; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Neuromuscular muscle stimulation machine- Strength Setting

Intervention Type: DEVICE

Muscle stimulation to strength skeletal muscle

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.

Group Type: PLACEBO_COMPARATOR

Neuromuscular muscle stimulation machine - TENS Setting

Intervention Type: DEVICE

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

Interventions

Neuromuscular muscle stimulation machine- Strength Setting

Muscle stimulation to strength skeletal muscle

Intervention Type: DEVICE

Neuromuscular muscle stimulation machine - TENS Setting

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Pelvic fractures including acetabular and pelvic ring fracture that were fixed using open reduction internal fixation (ORIF) were considered.

Exclusion Criteria

• Patients who may be pregnant, have severe kidney injury or have a pacemaker were excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Barts & The London NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NMES Pilot Study

Identifier Type: -

Identifier Source: org_study_id