Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06411782
Other study ID # Foam Roller on SCM Muscle
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 12, 2024
Est. completion date June 1, 2025

Study information

Verified date May 2024
Source Istanbul Medipol University Hospital
Contact ESRA PEHLIVAN
Phone 02164189616
Email fztesrakambur@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to examine the acute effect of the foam roller (FR) method applied to the sternocleidomastoid (SCM) muscle after respiratory muscle fatigue on joint range of motion (ROM), accessory respiratory muscle activity and muscle strength. The aim of this study is to examine the changes in fatigue and pain symptoms by applying relaxation on the tense fascia and shortened muscle as a result of resistance training, and the effect of these changes in the sternocleidomastoid (SCM) muscle on joint range of motion (ROM) and muscle strength in healthy male or female participants aged 18-30. In line with the investigators' results, it may be recommended to add foam roller (FR) to the accessory respiratory muscles in the pulmonary rehabilitation program in patients with chronic lung diseases. For this reason, the investigators think that it will provide clinical and scientific benefits. The investigators believe that it will lead studies to add foam roller (FR) to the pulmonary rehabilitation program in patients with chronic lung diseases. Participants will be informed about the risks and benefits of participating in the study and a voluntary consent form will be signed. Participants will be given a demographic data form before starting the study and will be asked to fill it out. The hypermobility value will be measured according to the Beighton score before the participants start the tests. After the inspiratory muscle training (IMT) study, foam roller (FR) will be applied to the right sternocleidomastoid (SCM) muscle. A one week washout period will be given. Afterwards, the cases will be applied foam roller (FR) to the left sternocleidomastoid (SCM) muscle after the inspiratory muscle training (IMT) study. All evaluation parameters will be repeated before and after the applications. Maximum inspiratory pressure measurement, range of motion (ROM) measurements, muscle strength tests, flexibility with a myotony measuring device, electromyography (EMG) measurements will be made before the study one by one.


Description:

The sternocleidomastoid muscle (SCM) is one of the largest cervical muscles located in the superficial layer of the neck region. The primary movements of the muscle are rotation and lateral flexion. Sternocleidomastoid (SCM) tends to be overactive in many people. In general, when abnormal postures and abnormal positions are adopted, they have to work harder to help stabilize the neck area and thus the head. It is also the auxiliary respiratory muscle for breathing along with the scalene muscles. For this reason, it has been reported in the literature that in patients with chronic lung diseases who have low respiratory capacity, tension and trigger points in the sternocleidomastoid (SCM) occur due to overwork of this muscle all day. Foam Roller (FR) application is generally used to create pressure on soft tissues by using body weight and relaxation is achieved in the muscle. The aim of our study is to examine the acute effect of the foam roller (FR) method applied to the sternocleidomastoid (SCM) muscle after inspiratory muscle training (IMT) on range of motion (ROM) and muscle strength in healthy young adults. When the studies in the literature were examined, it was concluded that there was no study examining the effect of foam roller (FR) on sternocleidomastoid (SCM) before. In addition, there is no study examining the use of foam roller (FR) after inspiratory muscle training. First of all, the target group (healthy adults) determined for the project will be participants, taking into account the inclusion and exclusion criteria. Each participant will sign the Voluntary Consent Form and participate in the study. Participants will be asked to fill out a demographic data form before starting the study and hypermobility values will be measured according to the Beighton score before starting the tests. Sternocleidomastoid (SCM) is an accessory respiratory muscle located in the neck. Due to the sensitivity of its location and function, it is important to perform the foam roller (FR) application with the right technique. For this reason, all volunteers participating in the investigators' study will be informed about the anatomical structure and kinesiological nature of the sternocleidomastoid (SCM) muscle and the foam roller (FR) application will be taught. After the selection and informing of the volunteers, the cases before the study one by one; measurement of maximum inspiratory pressure (MIP), range of motion (ROM) measurements, muscle activity measurement with electromyography (EMG), muscle strength tests, flexibility status parameters will be measured with a myotony measuring device. After all evaluations have been made, 30 breaths will be applied with 2 repetitions of inspiratory muscle training (IMT) with a Power Breathe device, 80% of the Maximum Inspiratory Pressure (MIP). After inspiratory muscle training (IMT), foam roller (FR) application on the sternocleidomastoid (SCM) muscle will be applied with 3 sets of 1 minute and a 30-second listening period between each set. 27 healthy cases will be included in our study. After the inspiratory muscle training (IMT) study, first foam roller (FR) will be applied to the right sternocleidomastoid (SCM) muscle in each included case, and then it will be evaluated with the evaluation criteria. After a 1 week washout period, foam roller (FR) will be applied to the left sternocleidomastoid (SCM) muscle after inspiratory muscle training (IMT) application. All measurements will be repeated immediately after the application and 15 minutes later. The analysis of the data to be obtained will be carried out using the Statistical Package for the Social Sciences (SPSS) 25 package program. As a result of the success of the project, it is thought that it will be a source of inspiration for new studies in patients with chronic lung diseases. The project is an undergraduate thesis and if it is realized, it will contribute to the training of qualified and young researchers in our country.


Recruitment information / eligibility

Status Recruiting
Enrollment 27
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Healthy Adults - Not exercising regularly for the last 6 months - To have participated in the study voluntarily - Individuals without widespread visceral or musculoskeletal pain were included. Exclusion Criteria: - Using pain medication - Soft tissue, muscle and bone injury - Spinal cord or upper extremity injuries - Fibromyalgia - Cases treated with myofascial release - Individuals who did not have hypermobility according to the Beighton score were excluded.

Study Design


Intervention

Device:
Foam roller
In foam roller application, a partitioned FR from the Trigger Point Grid 2.0 brand, measuring 33x14 cm and weighing 0.9 kg, with an inner part made of polyvinylchloride (PVC), will be used. Participants will roll the segmented FR with slight flexion-extension by placing the FR on the SCM muscle to apply FR from the starting point to the end point of that muscle region for the selected SCM muscle, with the person in the side stance position against the wall. This action will consist of 3 sets of 1 minute each, with a 30-second rest period between each set. It will be applied once for each region, including the right and left SCM muscle.
Inspiratory muscle training
Inspiratory muscle training will be done with a resistive exercise device at 80% of MIP max and for 30 breaths.

Locations

Country Name City State
Turkey University of Health Sciences Turkey Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Stiffness and Muscle Tone of sternocleidomastoid muscle Elasticity measurement will be evaluated with the MyotonPro brand device. Measurements will be made while the subjects are in the sitting position. Primarily, marking will be made between the adhesion site of the sternocleidomastoid (SCM) to the anterior surface of the manubrium sterni and the adhesion on the mastoid process of the temporal bone. Then the measurement will be made. The probe of the device (3 mm diameter) will be placed perpendicular to the skin surface with a constant preload (0.18 N). 1 Hour
Primary Electromyographic activity level measurement of sternocleidomastoid muscle Trigno Avanti brand surface electromyography (EMG) measurement sensors will be used to record the superficial EMG signals. The skin area will be cleaned with alcohol. Contraction of the sternocleidomastoid (SCM) muscle will be achieved by performing SCM neck flexion movement and electrode placement will be determined by palpating the muscle midpoint. During the initial evaluation, after the inspiratory muscle training (IMT) study and after the foam roller (FR) application, measurements will be made from both SCM muscles. During the intervention
Secondary Sternocleidomastoid Muscle Strength Measurements Lafayette hand dynamometer will be used. The device can give data such as peak power, time to reach peak power, total test time and average force in lbs. When the cervical region is in the neutral position, the device will be placed on the sternocleidomastoid muscle 90 degrees perpendicular and the make test protocol will be applied. Make test is the protocol of applying maximum force against the device by the person being measured while holding the dynamometer steady. Patients will be asked to perform lateral flexion, flexion and rotation movements in the supine position. And resistance will be applied in the opposite direction. Performing three repetitions will save the higher value. Measurements will be measured from the same part of the muscle each time, and the practitioner and the extremity performing the test will be the same. 1 Hour
Secondary Cervical joint range of motion Cervical joint range of motion will be evaluated with a Universal goniometer. The pivot point will be placed on the C7 spinous process and the fixed arm will be kept perpendicular to the ground while the moving arm measures the movement of the cervical spinous process. The expected flexion angle is 45°. 1 Hour
Secondary Maximum Inspiratory Pressure Measurement Measurements were taken with Pony Fx, mouth pressure measurement module Spirometer Device. After the appropriate filter and mouthpiece were attached to the spirometer, the nasal airway was closed with a clip. After inhaling against the completely closed airway for 20 seconds or for 10 breaths, the person was asked to inhale at the maximum rate at a time while sitting at the residual volume, to discharge the inhaled air from the nose. Measurement will be made again until the peak value is obtained., the highest value was recorded. 1 Hour
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04677920 - The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology N/A
Active, not recruiting NCT03312920 - Investigating Memory Retrieval Improvement in Healthy Subjects N/A
Completed NCT03309072 - Investigating Accelerated Learning and Memory in Healthy Subjects Using a Face Name Memory Task N/A
Completed NCT03289832 - Effect of Orally Delivered Phytochemicals on Aging and Inflammation in the Skin N/A
Enrolling by invitation NCT06133530 - Human Milk Oligosaccharides (HMOs) and Gut Microbiota, Immune System in Antarctica N/A
Completed NCT05141903 - Dietary Supplement With and Without a Probiotic and/or Antibiotic
Completed NCT01689259 - Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults Phase 1
Completed NCT01187875 - Resistant Starch and Satiety Phase 0
Completed NCT03312699 - Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort Phase 1
Completed NCT03319134 - Investigating the Neural Correlates in Memory Retrieval After HD-tDCS N/A
Recruiting NCT04104360 - Galacto-oligosaccharides and Intestinal Activity N/A
Completed NCT03228693 - Gene Expression and Biomarker Profiling of Keloid Skin N/A
Completed NCT04206293 - A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers N/A
Completed NCT04146532 - Aspirin Effects on Emotional Reactions Early Phase 1
Recruiting NCT06011018 - Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke N/A
Completed NCT05093205 - STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS Phase 1
Completed NCT04596709 - Investigation of Blood Glucose and Insulin Response After Intake of Vitalose N/A
Completed NCT04272450 - Respiratory Muscle Strength in Different Age Groups
Completed NCT02044679 - Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions N/A
Completed NCT01402973 - Pilot Study of a Dietary Intervention Based Upon Advanced Glycation End Products N/A