Interferential Current Therapy After Total Knee Arthroplasty

NCT ID: NCT03542981

Last Updated: 2018-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-09

Study Completion Date

2015-09-01

Brief Summary

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Interferential current is widely used as a popular treatment in painful musculoskeletal disorders. And total knee arthroplasty patients present with extreme pain immediately after surgery. So this study is aimed to investigate the effectiveness of interferential current implementation following total knee arthroplasty surgery. In this study interferential current compared with sham interferential current . Patients were assessed with pain, range of motion , edema and the amount of used paracetamol.

Detailed Description

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A total of 132 patients ranging in 60-85 years who were undergoing their first total knee arthroplasty due to knee OA were recruited into a randomized, double-blind, prospective and controlled study. Participants were recruited at the Orthopedics and Traumatology inpatient clinic. The patients were seen postoperative first day and were assigned to receive either interferential current or sham interferential current by block randomization. After the procedure was explained to each subject, interferential current treatment was applied 2 times for 5 days, each treatment was continued approximately 30 minutes. Four electrodes were used to deliver quadripolar interferential current Subjects were told that in order to produce an effect, the intensity of the stimulator must be maintained at a "strong but comfortable level" at all times. The sham interferential current treatment consisted of the placement of the same pads for the same time but no electrical stimulation was applied to the probes. At the same time, all patients received standard postoperatively rehabilitation program. Patients were assessed with pain, range of motion , edema and the amount of used paracetamol.

Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Interferential Current Treatment

Interferential Current group received interferential current treatment 30 minutes, 2 times a day for 5 days after the surgery.

Group Type ACTIVE_COMPARATOR

Interferential Current

Intervention Type DEVICE

Sham Interferential Current Treatment

In the sham interferential Current treatment, no electrical stimulation was applied to the probes with the same pads for the same time.

Group Type SHAM_COMPARATOR

Sham Interferential Current

Intervention Type DEVICE

Interventions

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Interferential Current

Intervention Type DEVICE

Sham Interferential Current

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

•Patients who underwent total knee arthroplasty surgery

Exclusion Criteria

* Patients who had experienced of any electrotherapy prior to the TKA to be sure blinding of therapy
* Patients who had history of any contraindication for electrotherapy
* Patients who had chronic pain rather than knee OA
* Patients who had experienced a known or suspected joint infection or a specific condition (ie, peripheral or central nervous system lesions, neoplasm, diabetes mellitus, osteonecrosis, recent trauma and pacemaker)
* Patients who had history of stroke, central nervous disease, mental impairment or poor general health status that would interfere with functional assessments during the study
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Resul KADI

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mehmet r kadı, MD

Role: PRINCIPAL_INVESTIGATOR

Ege University School of Medicine

Simin Hepguler, prof

Role: STUDY_DIRECTOR

Ege University School of Medicine

Funda C Atamaz, prof

Role: STUDY_CHAIR

Ege University School of Medicine

Emine Dede, md

Role: STUDY_CHAIR

Ege University School of Medicine

Semih Aydogu, prof

Role: STUDY_CHAIR

Ege University School of Medicine

Kemal Aktuğlu, prof

Role: STUDY_CHAIR

Ege University School of Medicine

Nadir Ozkayın, prof

Role: STUDY_CHAIR

Ege University School of Medicine

Cihat Ozturk, prof

Role: STUDY_CHAIR

Ege University School of Medicine

Locations

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Ege University School of Medicine Hospital

Izmir, Bornova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TKP35IF

Identifier Type: -

Identifier Source: org_study_id

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