Interferential Current Therapy After Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

Is Interferential Current Effective in the Management of Pain, Range of Motion, Edema Following Total Knee Arthroplasty Surgery?: Randomized Double-blind Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542981
• Other study ID #: TKP35IF
• Status: Completed
• Phase: N/A
• Start date: September 9, 2014
• Est. completion date: September 1, 2015

Study information

• Verified date: May 2018
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: September 1, 2015
• Est. primary completion date: September 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Device:
• Interferential Current

• Sham Interferential Current

Locations

Country	Name	City	State
Turkey	Ege University School of Medicine Hospital	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain from baseline measured by visual analog scale	Pain intensity that was measured by visual analog scale (minimum score:0; maximum score:100)(higher values represent worse outcome)	Change in pain measured 5th and 30th days after surgery
Secondary	Change of Range of Motion from baseline	The measurement of the range of the motion was performed by a goniometer of active extension and flexion (higher values represent better outcome)	Change of Range of Motion measured 5th and 30th days after surgery
Secondary	Change of Edema from baseline	Edema as a change in circumference from the preoperative value was measured by a meter (higher values represent worse outcome)	Change of Edema measured 5th and 30th days after surgery
Secondary	Amount of used paracetamol	the paracetamol intake was recorded as gr. (higher values represent worse outcome)	5th and 30th days after surgery