Interferential Current Therapy After Total Knee Arthroplasty

NCT03542981 | Completed

• 1 other identifier: TKP35IF
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Keywords

pain; surgery; interferential current; total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of Range of Motion from baseline

  Change of Range of Motion measured 5th and 30th days after surgery

• Change of Edema from baseline

  Change of Edema measured 5th and 30th days after surgery

• Amount of used paracetamol

  5th and 30th days after surgery

Study Arms (2)

Interferential Current Treatment

ACTIVE COMPARATOR

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

Device: Interferential Current

Sham Interferential Current Treatment

SHAM COMPARATOR

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

Device: Sham Interferential Current

Interventions

Interferential Current DEVICE

Interferential Current Treatment

Sham Interferential Current DEVICE

Sham Interferential Current Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent total knee arthroplasty surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University School of Medicine Hospital

Izmir, Bornova, 35030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• mehmet r kadı, MD

  Ege University School of Medicine

  PRINCIPAL INVESTIGATOR

• Simin Hepguler, prof

  Ege University School of Medicine

  STUDY DIRECTOR

• Funda C Atamaz, prof

  Ege University School of Medicine

  STUDY CHAIR

• Emine Dede, md

  Ege University School of Medicine

  STUDY CHAIR

• Semih Aydogu, prof

  Ege University School of Medicine

  STUDY CHAIR

• Kemal Aktuğlu, prof

  Ege University School of Medicine

  STUDY CHAIR

• Nadir Ozkayın, prof

  Ege University School of Medicine

  STUDY CHAIR

• Cihat Ozturk, prof

  Ege University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: June 1, 2018
• Study Start: September 9, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 1, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)