LLLT and Russian Electrical Stimulation in Osteoarthritis

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

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.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05360-160
    • Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	numeric pain rating scale (0-10) with a minimal clinically important change of two points	6 months from baseline (follow up)
Functionality	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).	6 months from baseline (follow up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication intake	Paracetamol	6 months from baseline (follow up)
Mobility and balance	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.	6 months from baseline (follow up)
Range of motion of the knees	was measured with a universal goniometer (AESCULAP).	6 months from baseline (follow up)
Muscular strength	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.	6 months from baseline (follow up)
Activity	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.	6 months from baseline (follow up)

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Patricia P Alfredo, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: low level laser therapy; Russian electrical stimulation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 0775/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No