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LLLT and Russian Electrical Stimulation in Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04788706
Recruitment Status : Completed
First Posted : March 9, 2021
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Study Description
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Brief Summary:

Objectives: To investigate the effect of low-level laser therapy (LLLT) application combined with Russian Electrical Stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee.

Design: Randomized controlled double-blind study. Setting: Specialist Rehabilitation Services.


Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Other: Low level Laser Therapy and Russian electrical stimulation Other: Placebo Laser and Russian electrical stimulation Other: Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation Other: Placebo Laser and Placebo Laser plus Russian electrical stimulation Not Applicable

Detailed Description:

ABSTRACT Objectives: To investigate the effect of low-level laser therapy (LLLT) application combined with Russian Electrical Stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee.

Design: Randomized controlled double-blind study. Setting: Specialist Rehabilitation Services. Participants: Eighty participants with knee osteoarthritis were randomized. Intervention: Participants were randomized into four groups: Group I (n=20; LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation), Group II (n=20; Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation), Group III (n=20; LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation), Group IV (n=20; Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation). The groups treated with LLLT received treatments with invisible infrared laser (904 nm, 3 Joules/point). The Placebo groups received identical treatment, but the infrared laser output was disabled. The sessions occurred three times a week.

Main outcome measures: The primary outcome was the change in knee pain and functionality (Lequesne). Secondary outcomes included change in mobility (8 meters and Timed Up and Go test), range of motion (goniometer), muscular strength (dynamometer), activity (Western Ontario and McMaster Universities Osteoarthritis questionnaire) and medication intake.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Low-level Laser Therapy Associated With Russian Electrical Stimulation in Knee Osteoarthritis: a Randomized Controlled Double-blind Study
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group I
LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation
 Other: Low level Laser Therapy and Russian electrical stimulation
LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation
Placebo Comparator: Group II
Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation
 Other: Placebo Laser and Russian electrical stimulation
Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation
Active Comparator: Group III
LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation
 Other: Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation
LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation
Placebo Comparator: Group IV
Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation
 Other: Placebo Laser and Placebo Laser plus Russian electrical stimulation
Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 6 months from baseline (follow up) ]
    numeric pain rating scale (0-10) with a minimal clinically important change of two points

  2. Functionality [ Time Frame: 6 months from baseline (follow up) ]
    Was measured using the Lequesne questionnaire (11 questions about pain, discomfort and function). Scores range from 0 to 24 (from 'no' to 'extremely severe' dysfunction).


Secondary Outcome Measures :
  1. Medication intake [ Time Frame: 6 months from baseline (follow up) ]
    Paracetamol

  2. Mobility and balance [ Time Frame: 6 months from baseline (follow up) ]
    were evaluated by the Timed Up and Go (TUG) test19 and the 8-meter walk test.20 The TUG test, a measure of functional mobility, quantifies in seconds the time that the individual needs to stand up from a chair, walk 3m, turn back toward the chair and sit down again. The 8-meter walk test measures the time and number of steps required for a person to walk 8m.

  3. Range of motion of the knees [ Time Frame: 6 months from baseline (follow up) ]
    was measured with a universal goniometer (AESCULAP).

  4. Muscular strength [ Time Frame: 6 months from baseline (follow up) ]
    was estimated at maximal isometric force for the quadriceps, using a portable dynamometer (Lafayette, USA). Under stabilized conditions, patients, sitting with knees flexed at 60 (measured by a goniometer),21 were asked to extend the legs as far as they could. Three trials were conducted, and the mean value was obtained.

  5. Activity [ Time Frame: 6 months from baseline (follow up) ]
    was measured using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire,22 which is self-administered and measures pain, frozen joints and physical activity. Increased scores suggest decreased activity.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. levels 2-4 according to Kellgren-Lawrence grade
  2. aged 50-75 years
  3. both genders
  4. have knee pain and functional disability for at least three months
  5. according to the criteria of the American College for Rheumatology.

Exclusion Criteria:

  • cancer, diabetes, symptomatic hip osteoarthritis, or used antidepressants, anti-inflammatory medications or anxiolytics during six months prior to enrolment.
Contacts and Locations
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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): NCT04788706


Locations
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Brazil
Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo
São Paulo, Brazil, 05360-160
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Patricia P Alfredo, PhD University of Sao Paulo
More Information
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04788706    
Other Study ID Numbers: 0775/08
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

The results obtained with the study will be made available to participants at the end of the study. These data will be published in articles, so that the anonymity of the participants is guaranteed.

All subjects who agreed to participate in the study signed a free and informed consent form and authorized the dissemination of the study results in articles or abstracts presented at scientific congresses.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
low level laser therapy
Russian electrical stimulation
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases