NMES and Pelvic Fracture Rehabilitation

NCT03278834 | Completed

• 1 other identifier: NMES Pilot Study
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Muscle Strength

  Peak Torque muscle strength

  12 weeks post operation

Secondary Outcomes (1)

• Feasibility questionnaire

  12 weeks post operation

Study Arms (2)

Intervention Group

EXPERIMENTAL

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 Group

PLACEBO COMPARATOR

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

Neuromuscular muscle stimulation machine- Strength Setting DEVICE

Muscle stimulation to strength skeletal muscle

Intervention Group

Neuromuscular muscle stimulation machine - TENS Setting DEVICE

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment and intervention group

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: September 12, 2017
• Study Start: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 12, 2017

Record last verified: 2017-07