Low Level Laser Therapy and Interferential Current in Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Active Interferential Current; Device: Placebo Interferential Current; Device: Placebo Laser; Device: Active Laser

• Registration Number: NCT02898025
• Lead Sponsor: Universidade Cidade de Sao Paulo

Brief Summary

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

Detailed Description

Interventional

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Primary Completion: 2017-03
• Study Completion: 2017-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G3 (Placebo IFC and Active Laser)	Placebo Interferential Current	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.
G4 (Placebo IFC and Placebo Laser)	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.
G1 (Active IFC and Active Laser)	Active Interferential Current	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.
G2 (Active IFC and Placebo Laser)	Active Interferential Current	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.
G4 (Placebo IFC and Placebo Laser)	Placebo Interferential Current	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.
G1 (Active IFC and Active Laser)	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.
G2 (Active IFC and Placebo Laser)	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.
G3 (Placebo IFC and Active Laser)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UNICID; 🇧🇷 Sao Paulo, SP, Brazil