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OpenTrials
Completed

NCT Number: NCT03542981

Interferential Current Therapy After Total Knee Arthroplasty

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University School of Medicine Hospital

Izmir, Bornova, 35030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferential Current

Device

Sham Interferential Current

Device

Primary outcomes

  1. Change in Pain from baseline measured by visual analog scale

    Time frame: 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 outcomes

  1. Change of Range of Motion from baseline

    Time frame: 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)

  2. Change of Edema from baseline

    Time frame: 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)

  3. Amount of used paracetamol

    Time frame: 5th and 30th days after surgery

    the paracetamol intake was recorded as gr. (higher values represent worse outcome)

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 1, 2018
Registry last updated
Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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