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Completed

NCT Number: NCT02067871

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

* 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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

About this study

  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LASER Therapy

Other

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

Electrical Stimulation

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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

  3. 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).

Sponsors and collaborators

Lead sponsor

Marco Aurélio Vaz, PhD

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 20, 2014
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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