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

NCT03882515 | Completed

• 1 other identifier: Trapezium Spectroscopy
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Trapezius Muscle Strain

Keywords

Neck Pain; Fascia; Modalities of Physiotherapy; Oxygenation

Outcome Measures

Primary Outcomes (1)

• Change from baseline deoxyhaemoglobin, oxyhaemoglobin and tissue oxygenation index at six weeks

  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 Outcomes (1)

• Change from baseline normalized EMG at 6 weeks

  Pre intervention, 3 weeks post intervention and 6 weeks post intervention

Other Outcomes (3)

• Change from baseline pain thresholds at 6 weeks

  Pre intervention, 3 weeks post intervention and 6 weeks post intervention

• Change from baselien Neck Desability Index at 6 weeks

  Pre intervention, 3 weeks post intervention and 6 weeks post intervention

• Change from Visual Analog Scale at 6 weeks

  Pre intervention, 3 weeks post intervention and 6 weeks post intervention

Study Arms (3)

Experimental group

EXPERIMENTAL

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

Other: Myofascial Release

Sham group

SHAM COMPARATOR

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

Other: Continuous Surface Slip Technique

Control group

ACTIVE COMPARATOR

Evaluation and reassessment of asymptomatic individuals

Other: Without intervention

Interventions

Myofascial Release 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.

Experimental group

Continuous Surface Slip Technique 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.

Sham group

Without intervention OTHER

Evaluation and re-evaluation without intervention

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

Study Sites (1)

Santa Catarina State University

Florianópolis, Santa Catarina, 88080350, Brazil

Location

Related Publications (1)

• 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.

  PMID: 38335169 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Myofascial Release Therapy; Methods

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Investigative Techniques

Study Officials

• Gilmar M Santos, PhD

  Santa Catarina State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 20, 2019
• Study Start: August 31, 2017
• Primary Completion: March 14, 2019
• Study Completion: July 30, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

BR (1)