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Low Level Laser Therapy and Interferential Current in Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02898025
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Richard Eloin Liebano, 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

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Active Interferential Current Device: Active Laser Device: Placebo Interferential Current Device: Placebo Laser Not Applicable

Detailed Description:
Interventional

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Level Laser Therapy and Interferential Current in Patients With Knee Osteoarthritis: Randomized Controlled Trial
Study Start Date : November 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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:
  • interferential therapy
  • IFC

Device: Active Laser
Involves the application of low level laser over the knee
Other Name: 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:
  • interferential therapy
  • IFC

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 Name: 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 Interferential Current
It is a sham interferential therapy

Device: Placebo Laser
It is a sham laser therapy




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898025


Locations
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Brazil
UNICID
Sao Paulo, SP, Brazil, 03071-000
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Investigators
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Principal Investigator: Richard E Liebano, PhD Universidade Cidade de Sao Paulo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Richard Eloin Liebano, Principal Investigator, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT02898025    
Other Study ID Numbers: RLiebano
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases