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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03438864
Other study ID # IF-Edema
Secondary ID
Status Completed
Phase N/A
First received February 13, 2018
Last updated February 22, 2018
Start date January 7, 2017
Est. completion date December 7, 2017

Study information

Verified date February 2018
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date December 7, 2017
Est. primary completion date December 7, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Other:
Control
No current except for first 5 seconds, device open but does not appy electrotherapy.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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