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Completed

NCT Number: NCT02898025

Low Level Laser Therapy and Interferential Current in Osteoarthritis

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNICID

São Paulo, 03071-000, Brazil

About this study

Interventional

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Interferential Current

Device

Involves the application of medium frequency alternating currents

Other names: interferential therapy, IFC

Active Laser

Device

Involves the application of low level laser over the knee

Other names: low level laser therapy

placebo interferential current

Device

It is a sham interferential therapy

Placebo Laser

Device

It is a sham laser therapy

Primary outcomes

  1. Pain intensity measured by a numeric pain scale ranging from 0 to 10.

    Time frame: 4 weeks

  2. Pressure Pain Threshold measured by a pressure algometer. Pressure will be recorded in kPa.

    Time frame: 4 weeks

Secondary outcomes

  1. TUG (Timed Up & Go Test)

    Time frame: Measure at baseline, 4 weeks, 3 months, 6 months

  2. Isokinetic Muscle Assessment

    Time frame: Measure at baseline, 4 weeks, 3 months, 6 months

  3. LeQuesne Questionnaire

    Time frame: Measure at baseline, 4 weeks, 3 months, 6 months

  4. WOMAC (Western Ontario and McMaster Universities Arthritis Index)

    Time frame: Measure at baseline, 4 weeks, 3 months, 6 months

Sponsors and collaborators

Lead sponsor

Universidade Cidade de Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 13, 2016
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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