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

NCT ID: NCT02067871

Last Updated: 2014-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-12-31

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).

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Electrical Stimulation

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Laser Therapy

Intervention Type: OTHER

Low-level laser therapy was administered twice a week with a minimum of 48h between sessions over a period of eight weeks.

Combined Treatment

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.

Group Type: EXPERIMENTAL

Laser Therapy

Intervention Type: OTHER

Low-level laser therapy was administered twice a week with a minimum of 48h between sessions over a period of eight weeks.

Electrical Stimulation

Intervention Type: 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.

Interventions

Laser Therapy

Low-level laser therapy was administered twice a week with a minimum of 48h between sessions over a period of eight weeks.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Low-Level Laser Therapy; Lasertherapy; Light therapy; Phototherapy; electrotherapy; electrical stimulation therapy; neuromuscular electrical stimulation

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

OTHER

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Marco Aurélio Vaz, PhD

OTHER

Sponsor Role: lead

Responsible Party

Marco Aurélio Vaz, PhD

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marco A Vaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

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

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

UFRGS - 20160

Identifier Type: -

Identifier Source: org_study_id