NMES and Pelvic Fracture Rehabilitation

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278834
• Other study ID #: NMES Pilot Study
• Status: Completed
• Phase: N/A
• First received: July 13, 2017
• Last updated: September 8, 2017
• Start date: January 1, 2014
• Est. completion date: June 1, 2014

Study information

• Verified date: July 2017
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 1, 2014
• Est. primary completion date: June 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Fractures
• Rehabilitation
• Trauma

Intervention

Device:
• Neuromuscular muscle stimulation machine- Strength Setting
Muscle stimulation to strength skeletal muscle
• Neuromuscular muscle stimulation machine - TENS Setting
Muscle stimulation to mimic the intervention but without the strength gains.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Barts & The London NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Strength	Peak Torque muscle strength	12 weeks post operation
Secondary	Feasibility questionnaire	questionnaire of 10 questions	12 weeks post operation