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Completed

NCT Number: NCT04788706

LLLT and Russian Electrical Stimulation in Osteoarthritis

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.

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Key information

Conditions

Osteo Arthritis Knee

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo

São Paulo, 05360-160, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • levels 2-4 according to Kellgren-Lawrence grade
  • aged 50-75 years
  • both genders
  • have knee pain and functional disability for at least three months
  • 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.

Treatment and study plan

Low level Laser Therapy and Russian electrical stimulation

Other

LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation

Placebo Laser and Russian electrical stimulation

Other

Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation

Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation

Other

LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation

Placebo Laser and Placebo Laser plus Russian electrical stimulation

Other

Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Efficacy of Low-level Laser Therapy Associated With Russian Electrical Stimulation in Knee Osteoarthritis: a Randomized Controlled Double-blind Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2021
Registry last updated
Mar 9, 2021

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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