LLLT and Russian Electrical Stimulation in Osteoarthritis

Osteo Arthritis Knee Clinical Trial

Official title:

Efficacy of Low-level Laser Therapy Associated With Russian Electrical Stimulation in Knee Osteoarthritis: a Randomized Controlled Double-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04788706
• Other study ID #: 0775/08
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2020
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Low level Laser Therapy and Russian electrical stimulation
LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation
• Placebo Laser and Russian electrical stimulation
Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation
• 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
• 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

Locations

Country	Name	City	State
Brazil	Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	numeric pain rating scale (0-10) with a minimal clinically important change of two points	6 months from baseline (follow up)
Primary	Functionality	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).	6 months from baseline (follow up)
Secondary	Medication intake	Paracetamol	6 months from baseline (follow up)
Secondary	Mobility and balance	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.	6 months from baseline (follow up)
Secondary	Range of motion of the knees	was measured with a universal goniometer (AESCULAP).	6 months from baseline (follow up)
Secondary	Muscular strength	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.	6 months from baseline (follow up)
Secondary	Activity	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.	6 months from baseline (follow up)