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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Laser Therapy; Other: Electrical Stimulation

• Registration Number: NCT02067871
• Lead Sponsor: Marco Aurélio Vaz, PhD

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 Timeline

• Study Start: 2012-03
• Primary Completion: 2012-08
• Study Completion: 2012-12
• Status Verified: 2014-02
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-18
• Last Update Submitted: 2014-02-18
• Study First Posted: 2014-02-20
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined Treatment	Laser Therapy	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.
Combined Treatment	Electrical Stimulation	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.
Electrical stimulation	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.
Laser Therapy	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

Primary Outcome Measures

Name	Time	Method
Torque change	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 Outcome Measures

Name	Time	Method
Muscular architecture change	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.

Trial Locations

Locations (1)

Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil