Acute Effects of Interferential Current on Edema, Pain and Muscle Strength in Patients With Distal Radius Fracture

Interferential current is a form of electrotherapy that is obtained by placing two different plates that produce medium frequency waveform current, resulting in a low frequency interferential waveform in deeper tissues. It was shown interferential current electrotherapy is beneficial for reduction of traumatic edema in tissues and pain control.

Patients with conservatively managed distal radius fractures were recruited after casts are shed, and were treated with one session(30 minutes) of different protocols of interferential current electrotherapy. Before and after therapy, they were evaluated with volumetry, hand grip strength and visual analogue scale for pain.

Study Overview

• Status: Completed
• Conditions: Pain; Edema; Radius Fractures
• Intervention / Treatment: Device: Electrotherapy, interferential current; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Conservatively managed distal radius fractures

Exclusion Criteria:

• Secondary conditions associated with edema(renal failure, congestive heart failure etc)
• Complex regional pain syndrome
• Compartment syndrome
• Contraindications for electrotherapy(cardiac pacemaker, thrombosis, pregnancy etc)
• Mental state unfit for electrotherapy
• Having treated with electrotherapy before

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 Hz; Interferential current, entry frequency 4000 Hz and 4010 Hz, beat frequency 10 Hz, amplitude was individualized and increased until patients felt a comfortable tickling sensation.	Device: Electrotherapy, interferential current; Interferential current, entry frequencies and beat frequencies were set differently in 2 groups, amplitude was individualized and increased until patients felt a comfortable tickling sensation.
Experimental: 100 Hz; Interferential current, entry frequency 4000 Hz and 4100 Hz, beat frequency 100 Hz, amplitude was individualized and increased until patients felt a comfortable tickling sensation.	Device: Electrotherapy, interferential current; Interferential current, entry frequencies and beat frequencies were set differently in 2 groups, amplitude was individualized and increased until patients felt a comfortable tickling sensation.
Sham Comparator: Placebo-Sham Control; No current except for first 5 seconds, device open but does not appy electrotherapy.	Other: Control; No current except for first 5 seconds, device open but does not appy electrotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetry	Patients were asked to dip their hands slowly into a special bucket full of water with volume markings until their middle finger touched to the bottom of the bucket. The spilled amount of water were measured as milliliters.	30 minutes
Visual Analogue Scale	Patients were asked to express their discomfort level from pain in a scale ranging from 1 to 10(with the help of a 10 cm line), and point they showed were measured as millimeters.	30 minutes
Hand Grip Strength	Patients were asked to use a hydraulic hand dynamometer for hand grip strength in a position of 10 to 30 degrees of wrist extension, and results were registered as kilograms.	30 minutes

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2017
• Primary Completion (Actual): December 7, 2017
• Study Completion (Actual): December 7, 2017

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Radius fracture, Interferential current, edema, pain
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Edema; Radius Fractures
• Other Study ID Numbers: IF-Edema

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No