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Treatment of Knee Osteoarthritis: Neuromuscular Electrical Stimulation and Low-level Laser.

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Laser Therapy
Electrical Stimulation
Sponsored by
Marco Aurélio Vaz, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring neuromuscular electrical stimulation, low-level laser therapy, knee osteoarthritis, muscle architecture, functionality, neuromuscular parameters

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • elderly.
  • symptomatic knee osteoarthritis.
  • radiographic diagnostic of Grade 2 or 3 knee osteoarthritis.

Exclusion Criteria:

  • a body mass index higher than 40 Kg/m2.
  • a diagnosis of hip, ankle, or toe osteoarthritis.
  • the use of crutches for locomotion.
  • participation in a strength-training programme or physiotherapy treatment for knee osteoarthritis in the past six months.
  • neurological or cognitive disorders.
  • rheumatoid arthritis.
  • electronic implants.
  • previous or upcoming surgery (within three months).
  • any cardiorespiratory, neuromuscular, or metabolic disease that could represent an absolute contraindication or a contraindication to the performance of maximum strength tests.

Sites / Locations

  • Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Electrical stimulation

Laser Therapy

Combined Treatment

Arm Description

18-32 min of pulsed current. stimulation frequency of 80Hz (hertz). pulse duration of 200μs (microseconds). stimulation intensity fixed near to maximal tolerated.

λ = 810 nm (nanometers) continuous wave 200 mW (milliwatts) output power low-level laser therapy dose of 4-6J (Joules) per point six points at the knee joint

Electrical Stimulation: 18-32 min of pulsed current, stimulation frequency of 80Hz (hertz). pulse duration of 200μs (microseconds). stimulation intensity fixed near to maximal tolerated. and Laser Therapy: λ = 810 nm (nanometers) continuous wave 200 mW (milliwatts) output power low-level laser therapy dose of 4-6J (Joules) per point. six points at the knee joint.

Outcomes

Primary Outcome Measures

Torque change
Torque is an expression of the muscular strength and was assessed by dynamometry.

Secondary Outcome Measures

Muscular architecture change
Muscular architecture (muscle thickness, pennation angle and fascicle length) were assessed by ultrasonography.

Full Information

First Posted
February 11, 2014
Last Updated
February 18, 2014
Sponsor
Marco Aurélio Vaz, PhD
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02067871
Brief Title
Treatment of Knee Osteoarthritis: Neuromuscular Electrical Stimulation and Low-level Laser.
Official Title
Neuromuscular Electrical Stimulation and Low-level Laser: Combined Use for the Treatment of Knee Osteoarthritis in Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marco Aurélio Vaz, PhD
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effects of low-level laser therapy in combination with neuromuscular electrical stimulation on neuromuscular (muscular strength and morphology) and functional parameters (pain and functional tests) in elderly with knee osteoarthritis. The hypothesis is that the association of low-level laser therapy with neuromuscular electrical stimulation could reduce joint pain associated with the inflammation and consequently potentiates the effects of electrical stimulation on the muscular system.
Detailed Description
Participants was randomized into one of three intervention groups (intervention period = 8 weeks after a 4 weeks control period in all groups). Electrical stimulation group (18-32 min of pulsed current, stimulation frequency of 80Hz (Hertz), pulse duration of 200μs and stimulation intensity fixed near to maximal tolerated), Laser group (low-level laser therapy dose of 4-6J (Joules) per point, six points at the knee joint) Combined group (electrical stimulation and low-level laser therapy).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
neuromuscular electrical stimulation, low-level laser therapy, knee osteoarthritis, muscle architecture, functionality, neuromuscular parameters

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical stimulation
Arm Type
Experimental
Arm Description
18-32 min of pulsed current. stimulation frequency of 80Hz (hertz). pulse duration of 200μs (microseconds). stimulation intensity fixed near to maximal tolerated.
Arm Title
Laser Therapy
Arm Type
Experimental
Arm Description
λ = 810 nm (nanometers) continuous wave 200 mW (milliwatts) output power low-level laser therapy dose of 4-6J (Joules) per point six points at the knee joint
Arm Title
Combined Treatment
Arm Type
Experimental
Arm Description
Electrical Stimulation: 18-32 min of pulsed current, stimulation frequency of 80Hz (hertz). pulse duration of 200μs (microseconds). stimulation intensity fixed near to maximal tolerated. and Laser Therapy: λ = 810 nm (nanometers) continuous wave 200 mW (milliwatts) output power low-level laser therapy dose of 4-6J (Joules) per point. six points at the knee joint.
Intervention Type
Other
Intervention Name(s)
Laser Therapy
Other Intervention Name(s)
Low-Level Laser Therapy, Lasertherapy, Light therapy, Phototherapy
Intervention Description
Low-level laser therapy was administered twice a week with a minimum of 48h between sessions over a period of eight weeks.
Intervention Type
Other
Intervention Name(s)
Electrical Stimulation
Other Intervention Name(s)
electrotherapy, electrical stimulation therapy, neuromuscular electrical stimulation
Intervention Description
Neuromuscular electrical stimulation was administered twice a week with a minimum of 48h between sessions over a period of eight weeks and with progressive intensity and volume.
Primary Outcome Measure Information:
Title
Torque change
Description
Torque is an expression of the muscular strength and was assessed by dynamometry.
Time Frame
Torque was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Secondary Outcome Measure Information:
Title
Muscular architecture change
Description
Muscular architecture (muscle thickness, pennation angle and fascicle length) were assessed by ultrasonography.
Time Frame
Architecture was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Other Pre-specified Outcome Measures:
Title
Functional Performance change
Description
Functional performance was assessed using the six-minute walk test and the Timed Up and Go test.
Time Frame
Functional performace was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Title
Pain Change
Description
Pain was assessed by questionnaire
Time Frame
Pain was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Title
Muscular electrical activation change
Description
Electrical activation was assessed by electromyography (EMG).
Time Frame
Muscular electrical activation was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elderly. symptomatic knee osteoarthritis. radiographic diagnostic of Grade 2 or 3 knee osteoarthritis. Exclusion Criteria: a body mass index higher than 40 Kg/m2. a diagnosis of hip, ankle, or toe osteoarthritis. the use of crutches for locomotion. participation in a strength-training programme or physiotherapy treatment for knee osteoarthritis in the past six months. neurological or cognitive disorders. rheumatoid arthritis. electronic implants. previous or upcoming surgery (within three months). any cardiorespiratory, neuromuscular, or metabolic disease that could represent an absolute contraindication or a contraindication to the performance of maximum strength tests.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco A Vaz, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90690-200
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Treatment of Knee Osteoarthritis: Neuromuscular Electrical Stimulation and Low-level Laser.

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