Clinical trial NCT06184451: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled clinical trial, two arms randomized and blind.
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Functional disability
timeFrame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary outcomes:
measure: Numerical Pain Scale
timeFrame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
measure: Functional self-perception
timeFrame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
measure: Lower limb functionality
timeFrame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
measure: Self-perceived functionality
timeFrame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
measure: Maximum voluntary isometric contraction
timeFrame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
measure: Global Perception of Change scale
timeFrame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
measure: Functionality
timeFrame: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University
Study officials:
affiliation: Study Principal Investigator
name: Cid Gomes, PhD
role: PRINCIPAL_INVESTIGATOR
References: