LLLT and Russian Electrical Stimulation in Osteoarthritis

Not Applicable

Completed

• Conditions: Osteo Arthritis Knee
• Interventions: Other: Placebo Laser and Russian electrical stimulation; Other: Placebo Laser and Placebo Laser plus Russian electrical stimulation; Other: Low level Laser Therapy and Russian electrical stimulation; Other: Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation

• Registration Number: NCT04788706
• Lead Sponsor: University of Sao Paulo General Hospital

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 Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-12
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2021-03-04
• Last Update Submitted: 2021-03-04
• Study First Posted: 2021-03-09
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	Placebo Laser and Russian electrical stimulation	Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation
Group IV	Placebo 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
Group I	Low level Laser Therapy and Russian electrical stimulation	LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation
Group III	Low 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

Primary Outcome Measures

Name	Time	Method
Pain intensity	6 months from baseline (follow up)	numeric pain rating scale (0-10) with a minimal clinically important change of two points
Functionality	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 Outcome Measures

Name	Time	Method
Medication intake	6 months from baseline (follow up)	Paracetamol
Range of motion of the knees	6 months from baseline (follow up)	was measured with a universal goniometer (AESCULAP).
Mobility and balance	6 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.
Activity	6 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 strength	6 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.

Trial Locations

Locations (1)

Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo; 🇧🇷 São Paulo, Brazil