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

Primary Purpose

Radius Fractures, Edema, Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electrotherapy, interferential current
Control
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius Fractures focused on measuring Radius fracture, Interferential current, edema, pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    10 Hz

    100 Hz

    Placebo-Sham Control

    Arm Description

    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.

    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.

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 13, 2018
    Last Updated
    February 22, 2018
    Sponsor
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03438864
    Brief Title
    Acute Effects of Interferential Current on Edema, Pain and Muscle Strength in Patients With Distal Radius Fracture
    Official Title
    Acute Effects of Interferential Current on Edema, Pain and Muscle Strength in Patients With Distal Radius Fracture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 7, 2017 (Actual)
    Primary Completion Date
    December 7, 2017 (Actual)
    Study Completion Date
    December 7, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ege University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Radius Fractures, Edema, Pain
    Keywords
    Radius fracture, Interferential current, edema, pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    10 Hz
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    100 Hz
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo-Sham Control
    Arm Type
    Sham Comparator
    Arm Description
    No current except for first 5 seconds, device open but does not appy electrotherapy.
    Intervention Type
    Device
    Intervention Name(s)
    Electrotherapy, interferential current
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    No current except for first 5 seconds, device open but does not appy electrotherapy.
    Primary Outcome Measure Information:
    Title
    Volumetry
    Description
    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.
    Time Frame
    30 minutes
    Title
    Visual Analogue Scale
    Description
    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.
    Time Frame
    30 minutes
    Title
    Hand Grip Strength
    Description
    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.
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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