Low Level Laser Therapy and Interferential Current in Osteoarthritis

NCT ID: NCT02898025

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-08-31

Brief Summary

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

Detailed Description

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Interventional

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Active Interferential Current

Intervention Type DEVICE

Involves the application of medium frequency alternating currents

Active Laser

Intervention Type DEVICE

Involves the application of low level laser over the knee

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.

Group Type ACTIVE_COMPARATOR

Active Interferential Current

Intervention Type DEVICE

Involves the application of medium frequency alternating currents

Placebo Laser

Intervention Type DEVICE

It is a sham laser therapy

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.

Group Type ACTIVE_COMPARATOR

Active Laser

Intervention Type DEVICE

Involves the application of low level laser over the knee

Placebo Interferential Current

Intervention Type DEVICE

It is a sham interferential therapy

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.

Group Type PLACEBO_COMPARATOR

Placebo Interferential Current

Intervention Type DEVICE

It is a sham interferential therapy

Placebo Laser

Intervention Type DEVICE

It is a sham laser therapy

Interventions

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Active Interferential Current

Involves the application of medium frequency alternating currents

Intervention Type DEVICE

Active Laser

Involves the application of low level laser over the knee

Intervention Type DEVICE

Placebo Interferential Current

It is a sham interferential therapy

Intervention Type DEVICE

Placebo Laser

It is a sham laser therapy

Intervention Type DEVICE

Other Intervention Names

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interferential therapy IFC low level laser therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Cidade de Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Richard Eloin Liebano

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard E Liebano, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Cidade de Sao Paulo

Locations

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UNICID

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Alqualo-Costa R, Thome GR, Perracini MR, Liebano RE. Low-level laser therapy and interferential current in patients with knee osteoarthritis: a randomized controlled trial protocol. Pain Manag. 2018 May;8(3):157-166. doi: 10.2217/pmt-2017-0057. Epub 2018 May 3.

Reference Type DERIVED
PMID: 29722602 (View on PubMed)

Other Identifiers

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RLiebano

Identifier Type: -

Identifier Source: org_study_id