NCT03438864

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

February 13, 2018

Last Update Submit

February 22, 2018

Conditions

Radius FracturesEdemaPain

Keywords

Radius fracture, Interferential current, edema, pain

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

10 Hz

EXPERIMENTAL

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

100 Hz

EXPERIMENTAL

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

Placebo-Sham Control

SHAM COMPARATOR

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

Other: Control

Interventions

Electrotherapy, interferential currentDEVICE

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.

10 Hz100 Hz
ControlOTHER

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

Placebo-Sham Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Conservatively managed distal radius fractures

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Radius FracturesEdemaPain

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and InjuriesFractures, BoneSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Department of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 20, 2018

Study Start

January 7, 2017

Primary Completion

December 7, 2017

Study Completion

December 7, 2017

Last Updated

February 26, 2018

Record last verified: 2018-02