Evaluation Of Peripheral Muscle Oxygenation In Individuals With Muscular Idiopathic Pain With Myofascial Release

September 24, 2019 updated by: Gilmar Moraes Santos, University of the State of Santa Catarina

Evaluation Of Peripheral Muscle Oxygenation In Individuals With Muscular Idiopathic Pain Before And After Myofascial Release: A Randomized Controlled Trial

Introduction: Neck Pain (NP) is considered a common idiopathic disorder in the general population. Oriented from incorrect executions during daily activities the DPO compromises the trapezius muscle that has a viscoelastic coating called fascia, which, in turn, is a soft tissue component, belonging to the connective tissue, that permeates the entire human body. During some activities that generate muscle overload, the fascia may undergo energy demands in which the local blood supply may be decreased, causing tissue hypoxia to result in pain. Decreased tissue blood supply could limit or prevent slippage of myofascial tissues. However, myofascial release can influence mechanoreceptors within the fascia, contributing to changes in local fluid dynamics, reducing excessive muscle tension, capillary constriction, and increasing local blood flow. One of the tools available for hemodynamic evaluation is the Near Infrared Spectroscopy (NIRS), which can quantify and capture variations in hemoglobin levels. Aim: To investigate whether myofascial release improves peripheral muscle oxygenation, pain intensity, and functional capacity of individuals with trapezius muscle pain. Methods: It is a clinical, parallel, randomized, double blind controlled trial with three groups that will be divided into: experimental, Sham and control. The instruments to be used in the research will be: Pressure Algometer, Neck Disability Index Questionnaire, Visual Analogue Scale (VAS), NIRS and Electromyograph. The experimental group will receive a myofascial release protocol for 20 minutes once weekly for six weeks. The Sham group will receive a continuous surface slip technique for the same time and frequency and the control will perform the evaluation and re-evaluation. Results: The present research is expected to increase peripheral muscle oxygenation, decrease pain threshold and improve quality of life after 6 weeks of intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be a double-blind randomized controlled trial (evaluator and patient), parallel in three groups (experimental group, Sham and control). Participants will initially be evaluated by a trained investigator who will be blinded and assigned randomly (random numbers generated on the computer) block for the experimental, sham, and control groups by means of an opaque envelope draw. In group division, participants with pain may not be contemplated to participate in the myofascial release protocol intervention group. However, the research will count on a group that will be contemplated with the technique of continuous superficial sliding (massage), which in turn, the literature points out benefits and well-being in its application. Finally, a group of individuals without pain will be evaluated and reevaluated and evaluated as a means of preventing pain and reducing TM peripheral muscle oxygenation. When making the invitation to participate in the survey, individuals will not be required to participate if they do not agree, and therefore will not be penalized. Participants who agree to participate in the survey will sign a Free and Informed Consent Form (Annex I) and will be informed of the possibility of withdrawing from the survey at any stage, without penalty. The collection of the evaluation and intervention will be carried out in a salon Clinic School of Physiotherapy in the Center of Health and Sports Sciences (CEFID) of the State University of Santa Catarina (UDESC) in the city of Florianópolis - SC. All personal identification data of the participants will be preserved according to resolution of the national health council, taking into account the possibility of scientific dissemination of the results obtained. The risks of these procedures will be medium, since the participant may present muscle pain after the intervention protocol. To minimize these risks will be available, if necessary, attendance at the Clinic School of Physiotherapy. Volunteers of both sexes, aged from 18 years neck pain more specifically, in TM during daily or work activities. The sample will be selected in a non-probabilistic way for convenience, and the individuals will be divided into three groups: experimental, Sham and control. The control group will be formed by healthy individuals and will be paired with the experimental group according to age and gender taking into account that they are two relevant variables when addressing the fascia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88080350
        • Santa Catarina State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

The inclusion criteria for the two groups (experimental and Sham) in the research will be:

  • Subjects of both sexes over 18 years of age;
  • Subjects with pain in the trapezius muscle in the last three months without definite cause; Obs: They should present at least "moderate" pain in NDI sessions 1 and 3 in the subjective pain reported in VAS.

Exclusion Criteria:

The exclusion criteria for both groups will be:

  • Neurological diseases;
  • History of trauma or cervical spine surgeries;
  • Clinical diagnosis of hernia or nerve compression;
  • Previous physiotherapy (last three months).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Evaluation of peripheral muscle oxygenation in individuals with muscular idiopathic pain before and after myofascial release
Other: Myofascial Release
With the right hand in hand exerts caudal pressure in the superior fibers of the muscle, both sides by a minute and a half each. In the ventral decubitus, apply pressure and slip from T12 to the base of the skull nine times. Thumb in the individual's acromion and with the other to hold the pressure and slide in the direction of the other acromion three times. Hand at the base of the skull and with the contralateral tenar region perform pressure and slip in caudal direction on both sides by three times. Hand at the base of the skull and with the contralateral thumb exerting pressure and slip of C3 the distal insertion of the upper fibers on both sides. Thumbs at the base of the skull, exerting lateral traction of the fascia in opposite directions. Dorsal decubitus, thumbs above clavicles, perform detachment of fibers for one and a half minutes. Patient sitting, support the head of the metacarpals beside the spinous process from T1 to T12 and exert pressure and slip three times each.
Sham Comparator: Sham group
Evaluation of peripheral muscle oxygenation in individuals with muscular idiopathic pain before and after continuous surface slip technique
Other: Continuous Surface Slip Technique
  1. Individual in the ventral decubitus, position the entire palmar surface bilaterally in the spinous process of T1 in the caudal direction, performing superficial smoothing in a smooth and rhythmic movement up to T12.
  2. Return of the hands from the caudal direction towards the cranial direction, bypassing the lateral borders of the trapezius muscle following the direction of the inferior, middle and superior fibers.
  3. Continue surface smoothing with a smooth and rhythmic movement until the distal insertion of the trapezius upper fibers into the skull and resume step 1 slowly and continuously for 10 minutes.
Active Comparator: Control group
Evaluation and reassessment of asymptomatic individuals
Other: Without intervention
Evaluation and re-evaluation without intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline deoxyhaemoglobin, oxyhaemoglobin and tissue oxygenation index at six weeks
Time Frame: Pre intervention and 6 weeks post intervention
For the measurement of peripheral muscle oxygenation, near-infrared spectroscopy (PortaMon®, Artinis, The Netherlands) will be used. Near infrared spectroscopy depends primarily on two characteristics of human tissue. First, the relative transparency of the tissue to light and, secondly, the light absorption characteristics dependent on the oxygenation of hemoglobin. By using several different wavelengths, relative changes in hemoglobin concentration can be displayed continuously. It is a non-invasive, accessible, continuous measure, and can be performed in the laboratory, or even in the field and without the need of special infrastructure, since it has the portable format (ARTINIS MEDICAL SYSTEMS, 2017).
Pre intervention and 6 weeks post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline normalized EMG at 6 weeks
Time Frame: Pre intervention, 3 weeks post intervention and 6 weeks post intervention
The TeleMyo DTS Desk Receiver® (Noraxon USA Inc., Scottsdale, USA) electromyograph will be used for acquisition and processing of the electromyographic signals of the trapezius muscle with 16-bit resolution digital analogue converter and RRMC> 100 dB. The signals will be picked up at a sampling frequency of 2000 Hz, and stored by MR 3.2 software (Noraxon U.S.A. Inc., Scottsdale, USA). The electromyograph uses Direct Transmission System (DTS) technology, for surface EMG and other biomechanical sensors, which uses wireless technology for real-time data transmission. It has been used both to determine the time of onset of the muscular electrical activity as well as the intensity to which the muscle is active, that is, the amplitude of the activity (PERRY and BURNFIED, 1992).
Pre intervention, 3 weeks post intervention and 6 weeks post intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline pain thresholds at 6 weeks
Time Frame: Pre intervention, 3 weeks post intervention and 6 weeks post intervention
To evaluate pressure pain thresholds, a digital algometer (JTech Commander Algometer®, USA) will be used to allow the actual measurement of pain thresholds and tolerances. The Pressure Algometer features an easy-to-handle design (a visor and a tip) and fine resolution for clinical identification of changes in pain sensitivity. It provides an objective and efficient assessment for treatment planning and evolution monitoring (JTECH MEDICAL INDUSTRIES, 2017).
Pre intervention, 3 weeks post intervention and 6 weeks post intervention
Change from baselien Neck Desability Index at 6 weeks
Time Frame: Pre intervention, 3 weeks post intervention and 6 weeks post intervention
The Neck Desability Index is a ten-item questionnaire designed to assess functional disability and pain in the region of the cervical spine. The calculation of the scores is obtained by adding the points and then converting the result into value, considering only the items answered by the individual. For each section, the total possible score is 5: if the first statement is marked with the section score = 0, if the last statement is checked, 5. If all sections are marked the total score is calculated as follows: Example : 16 (total score) 50 (total score possible) x 100 = 32%. If a section is lost or not calculated: 16 (total score) 45 (total possible score) x 100 = 35.5%. Minimum Change Detectable (90% confidence): 5 points or 10% points.
Pre intervention, 3 weeks post intervention and 6 weeks post intervention
Change from Visual Analog Scale at 6 weeks
Time Frame: Pre intervention, 3 weeks post intervention and 6 weeks post intervention
One-dimensional instrument for the evaluation of the subjective intensity of pain. It is a line with the numbers numbered 0-10. At one end of the line is marked "no pain" and the other "worst pain imaginable" (MARTINEZ, et al., 2011).
Pre intervention, 3 weeks post intervention and 6 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of the State of Santa Catarina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gilmar M Santos, PhD, Santa Catarina State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Trapezium Spectroscopy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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