Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05210231
Other study ID # tDCS and Rotator Cuff
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 7, 2022
Est. completion date May 5, 2023

Study information

Verified date March 2023
Source University of Gran Rosario
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study will be to determine the effects of active tDCS on rotator cuff fatigue. This study will be a randomized, double-blind, sham-controlled, cross-over clinical trial based on non-probabilistic sampling for convenience, comprising a sample of 20 active asymptomatic subjects of all genders and aged between 18 and 35 years old. Subjects will be recruited via social networks, WhatsApp and emails and must be currently engaged in moderate physical activity (assessed by the IPAQ questionnaire) and asymptomatic at the time of assessment. In addition, participants will be asked not to perform any type of strenuous exercise and do not drink alcoholic or caffeinated beverages during the time the work is performed. The study will consist of three sessions, with an interval of 72 hours between them.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 5, 2023
Est. primary completion date April 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Age ranging between 18 to 35 years, all genders. - Healthy subjects - Moderate physical activity (evaluated by IPAQ questionnaire) - Do not perform any exhausting exercise and do not drink alcoholic or caffeinated beverages during the time the work is performed. Exclusion Criteria: - Subjects with trauma in the last three weeks or previous surgeries on the upper extremity, patients with pre-existing neurological or rheumatic conditions, pregnancy, medical history of epilepsy the convulsive event, subjects under analgesic drug treatment or have ingested drugs with central action in the last 72 hours.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Transcranial Direct Current Stimulation
The direct electric current will be applied through a pair of sponges humidified with saline solution (150 mMols of NaCl diluted in water Milli-Q) on the electrodes (35 cm2). The electrodes (anode and cathode) will be connected to a continuous electric stimulator (Model: Microestim Foco Research, Brand: NKL, Souza Cruz, Brusque - SC, Brazil), with one energy battery (9 V) and will be mounted in accordance with the International 10-20 EEG System. For anodal polarity stimulation over the left TC, the anodal electrode will be placed over the scalp on the T3 area located at 40% of the distance on the left from the Cz point. The cathode electrode will be placed over the contralateral supraorbital area (Fp2). Thereafter, a constant electric current of 2 mA will be applied for 20 min.

Locations

Country Name City State
Argentina University of Gran Rosario Rosario Santa Fe

Sponsors (1)

Lead Sponsor Collaborator
University of Gran Rosario

Country where clinical trial is conducted

Argentina, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Time to Exhaustion (TTE) To assess endurance performance, participants will perform a submaximal isometric time to exhaustion (TTE) task of the shoulder external rotator muscles at 50% of their maximal voluntary contraction (MVC), which will be performed during each visit. During the TTE each participant will receive visual feedback on a computer monitor showing the target force. The task will finish when their force is below the required target value for more than 3 s. None of the participants will be aware of the time elapsed during the test and results of all the sessions will be provided only after the completion of all visits. Participants' perception of effort will be measured using the RPE scale (Borg, 1998) every 20 s of the TTE task. Leg muscle pain will be assessed every 20 s by using the Numerical Pain Rating Scale (NPRS). At baseline, after 3 and 6 days
Primary Change in Maximum Voluntary Contraction (MVC) After a brief standardized warm-up with submaximal isometric contractions, all participants will perform a 6 seconds MVC of infraspinatus muscle. For the MVC, subjects will be standing, with the shoulder in adduction position and the elbow flexed at 90°. The record will be evaluated by a load cell S200 (Miotec™, Porto Alegre, Brazil). The MVC produced during this test will be used to calculate the participants' 50% MVC used in the subsequent TTE task of that visit. At baseline, after 3 and 6 days
Primary Change in Rating of Perceived Exertion (RPE) Borg rating of perceived exertion (RPE) is an outcome measure scale used in knowing exercise intensity prescription. The RPE will be evaluated using the BORG CR10 scale, its ranges are from "0" (no exertion) to "10" (maximum effort). The RPE will be evaluated using the BORG CR10 scale, its ranges are from "0" (no effort) to "10" (maximum effort). The perception of the effort of the participants will be measured every 20 s during the TTE task. At baseline, after 3 and 6 days
Secondary Change in Global Rating of Change Scale (GRCS) For the Global Rating of Change Scale, in the second and third visit, subjects will be asked about their perception of change in relation to the endurance task relative to their status at the first visit. After 3 and 6 days
Secondary Change in Electromyographic recordings (sEMG) Surface electromyography (sEMG) assessment will be performed on the infraspinatus and deltoid muscles, using an acquisition module with four analog channels (Miotec™, Biomedical Equipments, Porto Alegre, Brazil). The conversion from analog to digital signals will be performed by an A/D board with 16-bit resolution input range, sampling frequency of 2 kHz, common rejection module greater than 100 dB, signal-noise ratio less than 03 µV Root Mean Square and impedance of 109 O. The sEMG signals will be recorded through surface Ag/AgCl electrodes (Meditrace™, Canada) with a centre-to-centre distance of 2 centimeters, in a parallel orientation to the underlying muscle fibers. A ground electrode will be placed in the lateral epicondyle of the contralateral arm The skin will be shaved and cleaned using alcohol swabs, following standardized guidelines. A fatigue study will be carried out using a frequency analysis. At baseline, after 3 and 6 days
See also
  Status Clinical Trial Phase
Completed NCT03361592 - The Immediate Effects of Spinal Manipulative Therapy on Kinetic and Kinematic Symmetry. N/A
Completed NCT04665193 - An Approach to Screening for COVID-19 at Vancouver Airport N/A
Not yet recruiting NCT02238028 - Intervention Study on the Health Effects of Wearing Particulate Filtering Respirators N/A
Completed NCT03455933 - Action Mechanisms of Shock Waves on Pain N/A
Completed NCT05377164 - Long Term Effects of Different Dietary Protocols on Determinants of Health in Patients' Lymphocytes
Completed NCT04480398 - Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients
Completed NCT05899244 - Influence of Muscle Stretching and Neural Mobilizations on Lower Limbs Range of Motion in Asymptomatic Subjects. N/A
Completed NCT04387032 - Impact of Manipulation of Sacroiliac Joints on the Static Balance of the Body N/A
Recruiting NCT03237039 - Classification of the Sagittal Profile of the Spine in Asymptomatic Elderly Subjects N/A
Completed NCT06048237 - Investigating Diaphragm Thickness and Mobility in Healthy Parous and Nulliparous Volunteers Using RUSI
Completed NCT04775628 - Forces and Translation Distance During an Inferior Glide of the Shoulder N/A
Recruiting NCT06215040 - The Treatment Effect for Asymptomatic Common Bile Duct Stone
Recruiting NCT06197945 - Effects of Mulligan Bent Leg Raise With and Without Bowen Therapy on Hamstring Tightness in Asymptomatic Adults N/A
Completed NCT04741893 - Anal Canal Functional Assessment Using EndoFLIP N/A
Completed NCT04785079 - Instrument Assisted Soft Tissue Mobilization Effect on Blood Flow N/A
Completed NCT04360668 - Muscle Energy Techniques and Trigger Point Therapy in Asymptomatic Persons With Latent Trigger Point N/A
Completed NCT04367740 - ScreenNC, a Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the Virus That Causes COVID-19
Terminated NCT04346667 - Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds Phase 4
Not yet recruiting NCT05911828 - A Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combination ZY19489-Ferroquine in Adult Asymptomatic Plasmodium Falciparum Carriers Phase 1
Recruiting NCT04863976 - Effects of Different Stretching Techniques on Extensibility, Strength and Range of Motion in Football Athletes N/A