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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184451
• Other study ID #: 75610223.5.0000.5511
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: March 2024
• Source: University of Nove de Julho
• Contact: Cid Gomes, PhD
• Phone: +5511970941936
• Email: cid.andre[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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, and/or diagnosis established radiographically (determined by Kellgren and Lawrence grade 1 to 3 on a scale 1 to 4)

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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 mode, frequency of 150Hz, duration of 150us, and amplitude varying from 1-60mA or more as long as tolerated by the study participant, without causing pain. The application time will be proportional to the time of the exercise session, approximately 60 minutes. The researcher will evaluate the need to adjust the current intensity through the pulse amplitude regularly so that the stimulus does not accommodate.
• 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 causing pain. 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.

Locations

Country	Name	City	State
Brazil	Nove de Julho University	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional disability	Knee Injury and Osteoarthritis Outcome Score (KOOS). It aims to evaluate the domains of pain, symptoms, activities of daily living, function related to recreation and sports, and quality of life related to the knee. Totaling 42 items, each item must be answered using a Likert scale that ranges from 0 (best score) to 4 (worst score), and the score for each subscale ranges from 0 (worst score) to 100 (best score).	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	Numerical Pain Scale	The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	Functional self-perception	Pain self-efficacy questionnaire, structured into 10 items where each item is evaluated by selecting a number on a 7-point numerical scale (scores from 0 to 6), where 0 means "not at all confident" and 6 means "completely confident". The items cover different functions, from work, social activities, domestic tasks and coping with pain without medication. A total score is calculated from the sum of the scores for each of the 10 items, producing a total score that ranges from 0 to 60. Higher scores reflect stronger self-efficacy beliefs.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	Dynamic balance	Iimed up and go test, research participants will be instructed to get up from a chair, walk 3 meters comfortably and safely, come back and sit down in the chair. The time taken to complete this task will be measured using a stopwatch that will be started after the verbal command 'go' and stopped when the participant returns to the initial sitting position. A first attempt will be made to familiarize the participant with the procedure. Two assessments will then be carried out. The average of the two assessments will be recorded for later data analysis.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	Lower limb functionality	30 second sit and stand test. From a sitting position with feet flat on the floor and shoulder-width apart, arms crossed across the chest, the individual assessed must stand, with hips and knees fully extended. Then, he must sit down, with his lower part completely touching the seat, repeating these movements continuously for 30 seconds. The chair must be placed against the wall. The total number of complete cycles will be counted (standing up and sitting down represents one cycle).	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	Self-perceived functionality	Patient Specific Functional Scale. An easy-to-apply self-report instrument, validated for measuring disability related to specific tasks identified by the individual. The scale is made up of 11 (eleven) numbers, graduated from 0 (zero) to 10 (ten), where 0 (zero) represents inability to perform the activity and ten (ten) the ability to perform the activity at the level prior to the current condition.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	Maximum voluntary isometric contraction	manual dynamometer portable (Lafayette Manual Muscle System, Modelo 01165, Lafayette Instrument Company, Lafayette, IN). Four 5-second readings will be taken during maximal voluntary isometric contraction (MVIC) with a 30-second rest period between contractions. The first CIVM will familiarize the volunteer with carrying out the task. A new set of readings will be taken if a volunteer can perform three contractions with at least 10% variability. Strong and constant verbal stimuli will be used throughout the test. Always with the research participants' hands positioned crossed on the chest. Thus, bilateral assessments of the muscles, quadriceps, and gluteus medius will be carried out. The order of CIVM readings will be randomized to avoid collection bias. The research participant will remain in lateral decubitus with a pillow positioned between the legs, with the limb to be tested superiorly in a neutral position.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	Global Perception of Change scale	The perception of the global effect of the treatment by the research participant will be evaluated by the Global Perception of Change scale. The Global Perception of Change scale is a direct scale on the patient's self-perception when the intervention is performed. This scale consists of 11 points, ranging from -5 (worsening compared to the start of treatment), 0 (neutral) and +5 (improvement compared to the start of treatment), using the Portuguese version.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	Functionality	The World Health Organization Disability Assessment Schedule 2.0 short version (12 items) is a generic self-report assessment instrument developed by the World Health Organization (WHO) to assess functionality and disability during the last 30 days.For each item, a Likert-type scale will be used to define the severity of the limitation, with a score of 0 (Zero) denoting "no limitation" and 4 (four) denoting "extreme limitation or inability to function." The total score is the sum of all 12 items, where a score of 48 points represents the worst possible restriction.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.