Clinical trial NCT02067871: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: neuromuscular electrical stimulation
low-level laser therapy
knee osteoarthritis
muscle architecture
functionality
neuromuscular parameters
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-02-20
Enrollment: 44
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Torque change
timeFrame: Torque was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Secondary outcomes:
measure: Muscular architecture change
timeFrame: Architecture was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
Other outcomes:
measure: Functional Performance change
timeFrame: Functional performace was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
measure: Pain Change
timeFrame: Pain was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).
measure: Muscular electrical activation change
timeFrame: Muscular electrical activation was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9)
Locations:
city: Porto Alegre
country: Brazil
facility: Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Marco A Vaz, PhD
role: PRINCIPAL_INVESTIGATOR
References: