Clinical trial NCT04788706: LLLT and Russian Electrical Stimulation in Osteoarthritis
Official title: Efficacy of Low-level Laser Therapy Associated With Russian Electrical Stimulation in Knee Osteoarthritis: a Randomized Controlled Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: low level laser therapy
Russian electrical stimulation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Pain intensity
timeFrame: 6 months from baseline (follow up)
measure: Functionality
timeFrame: 6 months from baseline (follow up)
Secondary outcomes:
measure: Medication intake
timeFrame: 6 months from baseline (follow up)
measure: Mobility and balance
timeFrame: 6 months from baseline (follow up)
measure: Range of motion of the knees
timeFrame: 6 months from baseline (follow up)
measure: Muscular strength
timeFrame: 6 months from baseline (follow up)
measure: Activity
timeFrame: 6 months from baseline (follow up)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Patricia P Alfredo, PhD
role: PRINCIPAL_INVESTIGATOR
References: