Trials / Completed
CompletedNCT03278834
NMES and Pelvic Fracture Rehabilitation
The Use of Neuromuscular Electrical Stimulation With Pelvic Fracture Rehabilitation: A Randomised, Double Blind, Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Barts & The London NHS Trust · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Neuromuscular muscle stimulation machine- Strength Setting | Muscle stimulation to strength skeletal muscle |
| DEVICE | Neuromuscular muscle stimulation machine - TENS Setting | Muscle stimulation to mimic the intervention but without the strength gains. |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2017-09-12
- Last updated
- 2017-09-12
Source: ClinicalTrials.gov record NCT03278834. Inclusion in this directory is not an endorsement.