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LLLT and Russian Electrical Stimulation in Osteoarthritis

Primary Purpose

Osteo Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low level Laser Therapy and Russian electrical stimulation
Placebo Laser and Russian electrical stimulation
Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation
Placebo Laser and Placebo Laser plus Russian electrical stimulation
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring low level laser therapy, Russian electrical stimulation

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Group I

Group II

Group III

Group IV

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Medication intake
Paracetamol
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.
Range of motion of the knees
was measured with a universal goniometer (AESCULAP).
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.
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.

Full Information

First Posted
December 29, 2020
Last Updated
March 4, 2021
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04788706
Brief Title
LLLT and Russian Electrical Stimulation in Osteoarthritis
Official Title
Efficacy of Low-level Laser Therapy Associated With Russian Electrical Stimulation in Knee Osteoarthritis: a Randomized Controlled Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
low level laser therapy, Russian electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation
Arm Title
Group II
Arm Type
Placebo Comparator
Arm Description
Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation
Arm Title
Group III
Arm Type
Active Comparator
Arm Description
LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation
Arm Title
Group IV
Arm Type
Placebo Comparator
Arm Description
Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation
Intervention Type
Other
Intervention Name(s)
Low level Laser Therapy and Russian electrical stimulation
Intervention Description
LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation
Intervention Type
Other
Intervention Name(s)
Placebo Laser and Russian electrical stimulation
Intervention Description
Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation
Intervention Type
Other
Intervention Name(s)
Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation
Intervention Description
LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation
Intervention Type
Other
Intervention Name(s)
Placebo Laser and Placebo Laser plus Russian electrical stimulation
Intervention Description
Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation
Primary Outcome Measure Information:
Title
Pain intensity
Description
numeric pain rating scale (0-10) with a minimal clinically important change of two points
Time Frame
6 months from baseline (follow up)
Title
Functionality
Description
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).
Time Frame
6 months from baseline (follow up)
Secondary Outcome Measure Information:
Title
Medication intake
Description
Paracetamol
Time Frame
6 months from baseline (follow up)
Title
Mobility and balance
Description
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.
Time Frame
6 months from baseline (follow up)
Title
Range of motion of the knees
Description
was measured with a universal goniometer (AESCULAP).
Time Frame
6 months from baseline (follow up)
Title
Muscular strength
Description
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.
Time Frame
6 months from baseline (follow up)
Title
Activity
Description
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.
Time Frame
6 months from baseline (follow up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: cancer, diabetes, symptomatic hip osteoarthritis, or used antidepressants, anti-inflammatory medications or anxiolytics during six months prior to enrolment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia P Alfredo, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo
City
São Paulo
ZIP/Postal Code
05360-160
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The results obtained with the study will be made available to participants at the end of the study. These data will be published in articles, so that the anonymity of the participants is guaranteed. All subjects who agreed to participate in the study signed a free and informed consent form and authorized the dissemination of the study results in articles or abstracts presented at scientific congresses.

Learn more about this trial

LLLT and Russian Electrical Stimulation in Osteoarthritis

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