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

• Sponsor: Ege University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03438864
• Collaborator: (none)
• Enrollment: 105
• Arms: 3
• Actual Duration (Months): 11

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Radius Fractures; Edema; Pain	Device: Electrotherapy, interferential current; Other: Control	N/A

Study Design

• Study Type: Interventional
• 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: Jan 7, 2017
• Actual Primary Completion Date: Dec 7, 2017
• Actual Study Completion Date: Dec 7, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Volumetry [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ege University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Feb 20, 2018
• Last Update Posted: Feb 26, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Funda Atamaz Calis, Professor in Department of Physical Medicine and Rehabilitation, Ege University: Radius fracture, Interferential current, edema, pain
• Additional relevant MeSH terms: Edema; Fractures, Bone; Radius Fractures

Study Results

No Results Posted as of Feb 26, 2018