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

NCT ID: NCT03438864

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-07
• Study Completion Date: 2017-12-07

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.

Conditions

Radius Fractures; Edema; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Electrotherapy, interferential current

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Electrotherapy, interferential current

Intervention Type: DEVICE

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.

Placebo-Sham Control

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

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Control

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Funda Atamaz Calis

Professor in Department of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IF-Edema

Identifier Type: -

Identifier Source: org_study_id