Clinical trial NCT03542981: Interferential Current Therapy After Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: pain
surgery
interferential current
total knee arthroplasty
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain from baseline measured by visual analog scale
timeFrame: Change in pain measured 5th and 30th days after surgery
Secondary outcomes:
measure: Change of Range of Motion from baseline
timeFrame: Change of Range of Motion measured 5th and 30th days after surgery
measure: Change of Edema from baseline
timeFrame: Change of Edema measured 5th and 30th days after surgery
measure: Amount of used paracetamol
timeFrame: 5th and 30th days after surgery
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University School of Medicine Hospital
state: Bornova
Study officials:
affiliation: Ege University School of Medicine
name: mehmet r kadı, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University School of Medicine
name: Simin Hepguler, prof
role: STUDY_DIRECTOR
affiliation: Ege University School of Medicine
name: Funda C Atamaz, prof
role: STUDY_CHAIR
affiliation: Ege University School of Medicine
name: Emine Dede, md
role: STUDY_CHAIR
affiliation: Ege University School of Medicine
name: Semih Aydogu, prof
role: STUDY_CHAIR
affiliation: Ege University School of Medicine
name: Kemal Aktuğlu, prof
role: STUDY_CHAIR
affiliation: Ege University School of Medicine
name: Nadir Ozkayın, prof
role: STUDY_CHAIR
affiliation: Ege University School of Medicine
name: Cihat Ozturk, prof
role: STUDY_CHAIR
References: