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CompletedNCT03438864Updated Feb 26, 2018

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

An interventional study of Electrotherapy, interferential current and Control in Radius Fractures, Edema and Pain, sponsored by Ege University. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-02-26.

Sponsored by Ege University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2017, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Radius Fractures
  • Edema
  • Pain

Keywords

  • Radius fracture, Interferential current, edema, pain
03

In context

Radius Fractures

274 studies on the registry are indexed under Radius Fractures; 35 are open to participants now.

This study's enrollment of 105 is above the median of 60 across 219 interventional studies indexed under Radius Fractures.

Browse Radius Fractures studies →

Lead sponsor

Ege University is the lead sponsor of 375 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Conservatively managed distal radius fractures

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
105 participants (actual)

Study arms

  • 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

  • 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

  • Sham comparator
    Placebo-Sham Control

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

    Other: Control

Interventions

  • DeviceElectrotherapy, 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.

  • OtherControl

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 minutes

  2. 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.

    Time frame: 30 minutes

  3. 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.

    Time frame: 30 minutes

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Dec 2017, 11 months.

Of 94 non-industry interventional studies with no phase under Radius Fractures, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's 11 months is below that.

Counting every sponsor, half of 95 studies reached it within 22 months; a quarter within 11 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2018
First posted
Feb 20, 2018
StartActual
Jan 7, 2017
Primary completionActual
Dec 7, 2017
CompletionActual
Dec 7, 2017
Last update
Feb 26, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03438864
Lead sponsor
Ege University
Responsible party
Funda Atamaz Calis (Professor in Department of Physical Medicine and Rehabilitation, Ege University) — Principal investigator
First posted
Feb 20, 2018
Start date
Jan 7, 2017
Primary completion
Dec 7, 2017
Completion
Dec 7, 2017
Last update
Feb 26, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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