Interferential Current Therapy After Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Device: Interferential Current; Device: Sham Interferential Current

• Registration Number: NCT03542981
• Lead Sponsor: Ege University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-09-09
• Primary Completion: 2015-09-01
• Study Completion: 2015-09-01
• Status Verified: 2018-05
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-30
• Last Update Submitted: 2018-05-30
• Study First Posted: 2018-06-01
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interferential Current Treatment	Interferential Current	Interferential Current group received interferential current treatment 30 minutes, 2 times a day for 5 days after the surgery.
Sham Interferential Current Treatment	Sham Interferential Current	In the sham interferential Current treatment, no electrical stimulation was applied to the probes with the same pads for the same time.

Primary Outcome Measures

Name	Time	Method
Change in Pain from baseline measured by visual analog scale	Change in pain measured 5th and 30th days after surgery	Pain intensity that was measured by visual analog scale (minimum score:0; maximum score:100)(higher values represent worse outcome)

Secondary Outcome Measures

Name	Time	Method
Change of Edema from baseline	Change of Edema measured 5th and 30th days after surgery	Edema as a change in circumference from the preoperative value was measured by a meter (higher values represent worse outcome)
Amount of used paracetamol	5th and 30th days after surgery	the paracetamol intake was recorded as gr. (higher values represent worse outcome)
Change of Range of Motion from baseline	Change of Range of Motion measured 5th and 30th days after surgery	The measurement of the range of the motion was performed by a goniometer of active extension and flexion (higher values represent better outcome)

Trial Locations

Locations (1)

Ege University School of Medicine Hospital; 🇹🇷 İzmir, Bornova, Turkey