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

NCT06184451 | Recruiting DMC

• 1 other identifier: 75610223.5.0000.5511
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Numerical Pain Scale

  Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.

• Functional self-perception

  Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.

• Lower limb functionality

  Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.

• Self-perceived functionality

  Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.

• Maximum voluntary isometric contraction

  Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.

Study Arms (2)

Therapeutic exercise and Transcutaneous electrical nerve stimulation

EXPERIMENTAL

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.

Other: Therapeutic exercise; Device: Transcutaneous electrical nerve stimulation

Therapeutic exercise and Placebo Transcutaneous electrical nerve stimulation

PLACEBO COMPARATOR

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.

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

Interventions

Therapeutic exercise OTHER

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 exercise and Placebo Transcutaneous electrical nerve stimulation; Therapeutic exercise and Transcutaneous electrical nerve stimulation

Transcutaneous electrical nerve stimulation DEVICE

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.

Therapeutic exercise and Transcutaneous electrical nerve stimulation

Placebo transcutaneous electrical nerve stimulation DEVICE

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.

Therapeutic exercise and Placebo Transcutaneous electrical nerve stimulation

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, 01504-001, Brazil

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise Therapy; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Electric Stimulation Therapy; Analgesia; Anesthesia and Analgesia

Study Officials

• Cid Gomes, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cid Gomes, PhD

CONTACT

+5511970941936; cid.andre@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two physiotherapists will be responsible for recruiting and assessing inclusion and exclusion criteria. Therefore, a rheumatologist will be responsible for confirming the OA diagnosis of research participants. A researcher will be responsible for the randomization process. Two physiotherapists, blinded to randomization, will be responsible for the assessment procedures. Two other physiotherapists, one for each group, will apply the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Controlled clinical trial, two arms randomized and blind.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: March 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

BR (1)