LLLT and Russian Electrical Stimulation in Osteoarthritis

University of Sao Paulo General Hospital

Status: Completed

Conditions: Osteo Arthritis Knee

Treatments: Other: Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation; Other: Low level Laser Therapy and Russian electrical stimulation; Other: Placebo Laser and Russian electrical stimulation; Other: Placebo Laser and Placebo Laser plus Russian electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04788706

0775/08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

Group I

Active Comparator group

Description:

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

Treatment:

Other: Low level Laser Therapy and Russian electrical stimulation

Group II

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo Laser and Russian electrical stimulation

Group III

Active Comparator group

Description:

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

Treatment:

Other: Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation

Group IV

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo Laser and Placebo Laser plus Russian electrical stimulation