Efficacy of Low-level Laser Therapy Associated With Russian Electrical Stimulation in Knee Osteoarthritis: a Randomized Controlled Double-blind Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Pain intensity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group I
LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation
Intervention: Low level Laser Therapy and Russian electrical stimulation (Other)
Group II
Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation
Intervention: Placebo Laser and Russian electrical stimulation (Other)
Group III
LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation
Intervention: Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation (Other)
Group IV
Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation
Intervention: Placebo Laser and Placebo Laser plus Russian electrical stimulation (Other)
Outcomes
Primary Outcomes
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
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
- Medication intake(6 months from baseline (follow up))
- Range of motion of the knees(6 months from baseline (follow up))
- Mobility and balance(6 months from baseline (follow up))
- Activity(6 months from baseline (follow up))
- Muscular strength(6 months from baseline (follow up))