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

NCT02067871 | Completed

• 1 other identifier: UFRGS - 20160
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

neuromuscular electrical stimulation; low-level laser therapy; knee osteoarthritis; muscle architecture; functionality; neuromuscular parameters

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (1)

• Muscular architecture change

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

Other Outcomes (3)

• Functional Performance change

  Functional performace was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).

• Pain Change

  Pain was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9).

• Muscular electrical activation change

  Muscular electrical activation was measured 3 times during the study: baseline (week -4), before intervention (week 0) and post intervention (week 9)

Study Arms (3)

Electrical stimulation

EXPERIMENTAL

* 18-32 min of pulsed current. * stimulation frequency of 80Hz (hertz). * pulse duration of 200μs (microseconds). * stimulation intensity fixed near to maximal tolerated.

Other: Electrical Stimulation

Laser Therapy

EXPERIMENTAL

* 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

Other: Laser Therapy

Combined Treatment

EXPERIMENTAL

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.

Other: Laser Therapy; Other: Electrical Stimulation

Interventions

Laser Therapy OTHER

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

Also known as: Low-Level Laser Therapy, Lasertherapy, Light therapy, Phototherapy

Combined Treatment; Laser Therapy

Electrical Stimulation 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.

Also known as: electrotherapy, electrical stimulation therapy, neuromuscular electrical stimulation

Combined Treatment; Electrical stimulation

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marco Aurélio Vaz, PhD: lead
• Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

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

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Laser Therapy; Low-Level Light Therapy; Phototherapy; Electric Stimulation; Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Physical Stimulation; Investigative Techniques; Physical Therapy Modalities; Rehabilitation

Study Officials

• Marco A Vaz, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 20, 2014
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 20, 2014

Record last verified: 2014-02

Locations

BR (1)