LLLT and Russian Electrical Stimulation in Osteoarthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation | Other: Low level Laser Therapy and Russian electrical stimulation<br>* LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation<br>|
| Placebo Comparator: Group II<br>Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation | Other: Placebo Laser and Russian electrical stimulation<br>* Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation<br>|
| Active Comparator: Group III<br>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<br>* LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation<br>|
| Placebo Comparator: Group IV<br>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<br>* Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low level laser therapy, Russian electrical stimulation