LLLT and Russian Electrical Stimulation in Osteoarthritis

NCT04788706 | Completed

• 1 other identifier: 0775/08
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

low level laser therapy; Russian electrical stimulation

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  numeric pain rating scale (0-10) with a minimal clinically important change of two points

  6 months from baseline (follow up)

• 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 Outcomes (5)

• Medication intake

  6 months from baseline (follow up)

• Mobility and balance

  6 months from baseline (follow up)

• Range of motion of the knees

  6 months from baseline (follow up)

• Muscular strength

  6 months from baseline (follow up)

• Activity

  6 months from baseline (follow up)

Study Arms (4)

Group I

ACTIVE COMPARATOR

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

Other: Low level Laser Therapy and Russian electrical stimulation

Group II

PLACEBO COMPARATOR

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

Other: Placebo Laser and Russian electrical stimulation

Group III

ACTIVE COMPARATOR

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

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

Group IV

PLACEBO COMPARATOR

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

Other: Placebo Laser and Placebo Laser plus Russian electrical stimulation

Interventions

Low level Laser Therapy and Russian electrical stimulation OTHER

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

Group I

Placebo Laser and Russian electrical stimulation OTHER

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

Group II

Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation OTHER

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

Group III

Placebo Laser and Placebo Laser plus Russian electrical stimulation OTHER

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

Group IV

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• cancer, diabetes, symptomatic hip osteoarthritis, or used antidepressants, anti-inflammatory medications or anxiolytics during six months prior to enrolment.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo

São Paulo, 05360-160, Brazil

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Patricia P Alfredo, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: March 9, 2021
• Study Start: January 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 9, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)