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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04788706
Enrollment
80
Registered
2021-03-09
Start date
2019-01-01
Completion date
2020-12-01
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteo Arthritis Knee

Keywords

low level laser therapy, Russian electrical stimulation

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.

Interventions

OTHERLow level Laser Therapy and Russian electrical stimulation

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

OTHERPlacebo Laser and Russian electrical stimulation

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

OTHERLow 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

OTHERPlacebo 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

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity6 months from baseline (follow up)numeric pain rating scale (0-10) with a minimal clinically important change of two points
Functionality6 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

MeasureTime frameDescription
Range of motion of the knees6 months from baseline (follow up)was measured with a universal goniometer (AESCULAP).
Medication intake6 months from baseline (follow up)Paracetamol
Activity6 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.
Muscular strength6 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.
Mobility and balance6 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026