Low Level Laser Therapy and Interferential Current in Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898025
• Other study ID #: RLiebano
• Status: Completed
• Phase: N/A
• First received: April 20, 2016
• Last updated: October 24, 2017
• Start date: November 2015
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Interventional

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: August 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Active Interferential Current
Involves the application of medium frequency alternating currents
• Active Laser
Involves the application of low level laser over the knee
• Placebo Interferential Current
It is a sham interferential therapy
• Placebo Laser
It is a sham laser therapy

Locations

Country	Name	City	State
Brazil	UNICID	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity measured by a numeric pain scale ranging from 0 to 10.		4 weeks
Primary	Pressure Pain Threshold measured by a pressure algometer. Pressure will be recorded in kPa.		4 weeks
Secondary	TUG (Timed Up & Go Test)		Measure at baseline, 4 weeks, 3 months, 6 months
Secondary	Isokinetic Muscle Assessment		Measure at baseline, 4 weeks, 3 months, 6 months
Secondary	LeQuesne Questionnaire		Measure at baseline, 4 weeks, 3 months, 6 months
Secondary	WOMAC (Western Ontario and McMaster Universities Arthritis Index)		Measure at baseline, 4 weeks, 3 months, 6 months