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Clinical Trials/NCT02067871
NCT02067871CompletedNot Applicable

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

Marco Aurélio Vaz, PhD2 sites in 1 country44 target enrollmentStarted: March 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
44
Locations
2
Primary Endpoint
Torque change

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • a body mass index higher than 40 Kg/m
  • 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.

Outcomes

Primary Outcomes

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

  • Muscular architecture change(Architecture was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).)

Investigators

Sponsor
Marco Aurélio Vaz, PhD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Marco Aurélio Vaz, PhD

PhD

Federal University of Rio Grande do Sul

Study Sites (2)

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