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

February 18, 2014 updated by: Marco Aurélio Vaz, PhD

Neuromuscular Electrical Stimulation and Low-level Laser: Combined Use for the Treatment of Knee Osteoarthritis in Elderly

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90690-200
        • Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Electrical Stimulation
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.
Other Names:
  • electrotherapy
  • electrical stimulation therapy
  • neuromuscular electrical stimulation
Experimental: 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
Other: Laser Therapy
Low-level laser therapy was administered twice a week with a minimum of 48h between sessions over a period of eight weeks.
Other Names:
  • Low-Level Laser Therapy
  • Lasertherapy
  • Light therapy
  • Phototherapy
Experimental: Combined Treatment

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.
Other: Electrical Stimulation
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.
Other Names:
  • electrotherapy
  • electrical stimulation therapy
  • neuromuscular electrical stimulation
Other: Laser Therapy
Low-level laser therapy was administered twice a week with a minimum of 48h between sessions over a period of eight weeks.
Other Names:
  • Low-Level Laser Therapy
  • Lasertherapy
  • Light therapy
  • Phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Torque change
Time Frame: Torque was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Torque is an expression of the muscular strength and was assessed by dynamometry.
Torque was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular architecture change
Time Frame: Architecture was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Muscular architecture (muscle thickness, pennation angle and fascicle length) were assessed by ultrasonography.
Architecture was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Performance change
Time Frame: Functional performace was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Functional performance was assessed using the six-minute walk test and the Timed Up and Go test.
Functional performace was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Pain Change
Time Frame: Pain was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Pain was assessed by questionnaire
Pain was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Muscular electrical activation change
Time Frame: Muscular electrical activation was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9)
Electrical activation was assessed by electromyography (EMG).
Muscular electrical activation was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

February 20, 2014

Last Update Submitted That Met QC Criteria

February 18, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFRGS - 20160

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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