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

University of Nove de Julho

Status: Enrolling

Conditions: Osteoarthritis, Knee

Treatments: Device: Placebo transcutaneous electrical nerve stimulation; Other: Therapeutic exercise; Device: Transcutaneous electrical nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06184451

75610223.5.0000.5511

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups, including a placebo group

Therapeutic exercise and Transcutaneous electrical nerve stimulation

Experimental group

Description:

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. 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. TENS will be applied with a portable device during the 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.

Treatment:

Device: Transcutaneous electrical nerve stimulation

Other: Therapeutic exercise

Therapeutic exercise and Placebo Transcutaneous electrical nerve stimulation

Placebo Comparator group

Description:

Participants in the control group will perform the same therapeutic exercise protocol previously reported in the experimental group, associated with placebo TENS. To do this, the device will only be turned on during the first minute of therapeutic exercises. The same TENS parameters as the experimental group will be applied for this.

Treatment:

Other: Therapeutic exercise

Device: Placebo transcutaneous electrical nerve stimulation