Low Level Laser Therapy and Interferential Current in Osteoarthritis

October 24, 2017 updated by: Richard Eloin Liebano, Universidade Cidade de Sao Paulo

Low Level Laser Therapy and Interferential Current in Patients With Knee Osteoarthritis: Randomized Controlled Trial

This study aims to evaluate the effectiveness of the low level laser therapy and interferential current in 168 patients with knee osteoarthritis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Interventional

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 03071-000
        • UNICID

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of osteoarthritis of the knee characterized by pain of mild or moderate intensity
  • Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria
  • Patients with knee osteoarthritis (s) according to the ACR criteria
  • VAS 3 to 8
  • 5 to 12 Lequesne
  • No complaint of pain in other joints of the lower limbs
  • Without neurological and cognitive disorders
  • No loss of sensation in the lower limbs
  • No surgery on the knee (s) in the last 6 months
  • Pain symptoms for at least 6 months
  • No infiltrations (s) knee (s) in the last 4 weeks
  • No use of analgesics 4 hours before treatment

Exclusion Criteria:

  • Individuals younger than 18 and older than 80 years
  • Complaints from other diseases of the lower limbs, knee prosthesis and / or hip joint instabilities and / or surgery in lower limbs, heart disease, uncontrolled hypertension and diabetes, coagulation disorders in anticoagulant therapy, pregnant women, fibromyalgia and individuals who can not perform isokinetic test who have difficulty performing the TUG, and those that are experiencing abnormal sensitivity to algometry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: G1 (Active IFC and Active Laser)
42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G1) will receive the treatment of Active Interferential Current and Active Laser for 12 sessions.
Device: Active Interferential Current
Involves the application of medium frequency alternating currents
Other Names:
  • IFC
  • interferential therapy
Device: Active Laser
Involves the application of low level laser over the knee
Other Names:
  • low level laser therapy
Active Comparator: G2 (Active IFC and Placebo Laser)
42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G2) will receive the treatment of Active Interferential Current and Placebo Laser for 12 sessions.
Device: Active Interferential Current
Involves the application of medium frequency alternating currents
Other Names:
  • IFC
  • interferential therapy
Device: Placebo Laser
It is a sham laser therapy
Active Comparator: G3 (Placebo IFC and Active Laser)
42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. This group (G3) will receive Placebo Interferential Current and Active Laser for 12 sessions.
Device: Active Laser
Involves the application of low level laser over the knee
Other Names:
  • low level laser therapy
Device: Placebo Interferential Current
It is a sham interferential therapy
Placebo Comparator: G4 (Placebo IFC and Placebo Laser)
42 patients with knee (s) osteoarthritis. All patients will receive guidance on the disease and on joint protection and energy conservation over a period of 50 minutes in a single session. The placebo group (G4) will receive Placebo Interferential Current and Placebo Laser for 12 sessions.
Device: Placebo Laser
It is a sham laser therapy
Device: Placebo Interferential Current
It is a sham interferential therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity measured by a numeric pain scale ranging from 0 to 10.
Time Frame: 4 weeks
4 weeks
Pressure Pain Threshold measured by a pressure algometer. Pressure will be recorded in kPa.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
TUG (Timed Up & Go Test)
Time Frame: Measure at baseline, 4 weeks, 3 months, 6 months
Measure at baseline, 4 weeks, 3 months, 6 months
Isokinetic Muscle Assessment
Time Frame: Measure at baseline, 4 weeks, 3 months, 6 months
Measure at baseline, 4 weeks, 3 months, 6 months
LeQuesne Questionnaire
Time Frame: Measure at baseline, 4 weeks, 3 months, 6 months
Measure at baseline, 4 weeks, 3 months, 6 months
WOMAC (Western Ontario and McMaster Universities Arthritis Index)
Time Frame: Measure at baseline, 4 weeks, 3 months, 6 months
Measure at baseline, 4 weeks, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Cidade de Sao Paulo

Investigators

  • Principal Investigator: Richard E Liebano, PhD, Universidade Cidade de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RLiebano

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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