Effects of TENS During the Performance of a Therapeutic Exercise Protocol in Individuals With Knee Osteoarthritis.

Official title

Effects of TENS During the Performance of a Therapeutic Exercise Protocol in Individuals With Knee Osteoarthritis: Controlled, Randomized, and Blinded Clinical Trial

Overview

Research participants diagnosed with knee Osteoarthritis will be randomized through a draw using sealed opaque envelopes indicating two groups: 1. Therapeutic Exercises + Transcutaneous electrical nerve stimulation and 2. Therapeutic Exercises + placebo Transcutaneous electrical nerve stimulation. Therefore, individuals of both sexes, aged 40 years or over, with a clinical diagnosis of unilateral osteoarthritis of the knee, who present with knee pain for more than three months, morning stiffness for less than 30 minutes, crepitus, bone sensitivity and absence of palpable heat, and diagnosis established radiographically (determined by Kellgren and Lawrence grade 1 to 3 on scale 1 to 4). Exclusion criteria are bilateral knee Osteoarthritis, hip Osteoarthritis, severe osteoporosis, fibromyalgia, clinical history of tumors or cancer, active inflammatory joint diseases (rheumatoid arthritis, gout), undergoing any lower extremity joint replacement, neurological disorders (Parkinson's disease, stroke, multiple sclerosis, muscular dystrophies, motor neuron disease, Alzheimer's disease), infected wounds or osteomyelitis in the knee region, deep vein thrombosis or thrombophlebitis, sensory changes in the lower limbs, cognitive impairment, and cardiopulmonary disorders that may prevent or limit the execution of exercises, use of a walking assistance device, history of recent trauma to the knee, having undergone any form of treatment involving physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotective within the six months before the start of interventions.

Interventions

• Other Therapeutic exercise
  The therapeutic exercise program includes a warm-up, resistance, neuromuscular, mobility, and balance exercises. Therapeutic exercises will be performed in up to three sets of 8-12 repetitions or 30-60 seconds each, with rest intervals of 90 seconds between sets.
• Device Transcutaneous electrical nerve stimulation
  TENS will be applied with a portable device, Neurodyn Portable System from Ibramed, while carrying out the entire therapeutic exercise program. The equipment has a two-phase and pulsed symmetric quadratic waveform. 5x5cm adhesive electrodes will be applied to the lateral and medial edges and superior and inferior to the patella, in a crossed manner, surrounding the region. The parameters established for the protocol of this study are based on a survey already carried out, with continuous pulse
• Device Placebo transcutaneous electrical nerve stimulation
  The equipment has a two-phase and pulsed symmetric quadratic waveform. 5x5cm adhesive electrodes will be applied to the lateral and medial edges and superior and inferior to the patella, in a crossed manner, surrounding the region. The parameters established for the protocol of this study are based on a survey already carried out, with continuous pulse mode, frequency of 150Hz, duration of 150us, and amplitude varying from 1-60mA or more as long as tolerated by the study participant, without ca

Primary outcome measures

• Functional disability [Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.]

Secondary outcome measures (7)

• Numerical Pain Scale [Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.]
• Functional self-perception [Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.]
• Lower limb functionality [Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.]
• Self-perceived functionality [Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.]
• Maximum voluntary isometric contraction [Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.]
• Global Perception of Change scale [Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.]
• Functionality [Time frame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.]

Eligibility criteria

Inclusion criteria

• clinical diagnosis of unilateral osteoarthritis of the knee
• presenting knee pain for more than three months
• morning stiffness for less than 30 minutes
• crepitus, bone tenderness, and absence of palpable heat.

Exclusion criteria

• Bilateral knee osteoarthritis, hip osteoarthritis
• severe osteoporosis
• fibromyalgia
• medical history of tumors or cancer
• active inflammatory joint diseases (rheumatoid arthritis, gout),
• undergoing any lower extremity joint replacement
• neurological diseases (Parkinson's disease, Accident Cerebral Vascular, Multiple Sclerosis, muscular dystrophies, motor neuron disease, Alzheimer's disease)
• infected wounds or osteomyelitis in the knee region
• deep vein thrombosis or thrombophlebitis
• sensory changes in the lower limbs
• cognitive and cardiopulmonary impairment that may prevent or limit performing the exercises
• using a walking assistance device
• having a history of recent trauma to the knee,
• having undergone any form of treatment involving physiotherapy
• intra-articular corticosteroids, anti-inflammatories, or chondroprotective in the six months before the start of the interventions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Nove de Julho University — São Paulo

Identifiers

NCT: NCT06184451 · 75610223.5.0000.5511

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗