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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067871
• Other study ID #: UFRGS - 20160
• Status: Completed
• Phase: N/A
• First received: February 11, 2014
• Last updated: February 18, 2014
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à PesquisaBrazil: Ethics CommitteeBrazil: Ministry of HealthBrazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Marco Aurélio Vaz, PhD	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional Performance change	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).	Yes
Other	Pain Change	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).	Yes
Other	Muscular electrical activation change	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)	Yes
Primary	Torque change	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).	Yes
Secondary	Muscular architecture change	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).	Yes