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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438864
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Funda Atamaz Calis, Ege University

Brief 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.


Condition or disease Intervention/treatment Phase
Radius Fractures Edema Pain Device: Electrotherapy, interferential current Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Effects of Interferential Current on Edema, Pain and Muscle Strength in Patients With Distal Radius Fracture
Actual Study Start Date : January 7, 2017
Actual Primary Completion Date : December 7, 2017
Actual Study Completion Date : December 7, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Volumetry [ Time Frame: 30 minutes ]
    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.

  2. Visual Analogue Scale [ Time Frame: 30 minutes ]
    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.

  3. Hand Grip Strength [ Time Frame: 30 minutes ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Funda Atamaz Calis, Professor in Department of Physical Medicine and Rehabilitation, Ege University
ClinicalTrials.gov Identifier: NCT03438864    
Other Study ID Numbers: IF-Edema
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Funda Atamaz Calis, Ege University:
Radius fracture, Interferential current, edema, pain
Additional relevant MeSH terms:
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Edema
Fractures, Bone
Radius Fractures
Wounds and Injuries
Signs and Symptoms
Forearm Injuries
Arm Injuries