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

NCT ID: NCT03882515

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2019-07-30

Brief Summary

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.

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.

Conditions

Trapezius Muscle Strain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Evaluation of peripheral muscle oxygenation in individuals with muscular idiopathic pain before and after myofascial release

Group Type: EXPERIMENTAL

Myofascial Release

Intervention Type: OTHER

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 group

Evaluation of peripheral muscle oxygenation in individuals with muscular idiopathic pain before and after continuous surface slip technique

Group Type: SHAM_COMPARATOR

Continuous Surface Slip Technique

Intervention Type: OTHER

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.

Control group

Evaluation and reassessment of asymptomatic individuals

Group Type: ACTIVE_COMPARATOR

Without intervention

Intervention Type: OTHER

Evaluation and re-evaluation without intervention

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Without intervention

Evaluation and re-evaluation without intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of the State of Santa Catarina

OTHER

Sponsor Role: lead

Responsible Party

Gilmar Moraes Santos

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gilmar M Santos, PhD

Role: PRINCIPAL_INVESTIGATOR

Santa Catarina State University

Locations

Santa Catarina State University

Florianópolis, Santa Catarina, Brazil

Countries

Brazil

References

Dos Santos Amorim M, Sinhorim L, Baptistella do Nascimento I, Wagner J, de Paula Lemos F, Duarte Franca ME, Schleip R, Sonza A, Moraes Santos G. Peripheral muscle oxygenation, pain, and disability indices in individuals with and without nonspecific neck pain, before and after myofascial reorganization(R): A double-blind randomized controlled trial. PLoS One. 2024 Feb 9;19(2):e0292114. doi: 10.1371/journal.pone.0292114. eCollection 2024.

Reference Type: DERIVED

PMID: 38335169 (View on PubMed)

Other Identifiers

Trapezium Spectroscopy

Identifier Type: -

Identifier Source: org_study_id