Clinical trial NCT03882515: Evaluation Of Peripheral Muscle Oxygenation In Individuals With Muscular Idiopathic Pain With Myofascial Release
Official title: Evaluation Of Peripheral Muscle Oxygenation In Individuals With Muscular Idiopathic Pain Before And After Myofascial Release: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trapezius Muscle Strain
Keywords: Neck Pain
Fascia
Modalities of Physiotherapy
Oxygenation
Lead sponsor: University of the State of Santa Catarina
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline deoxyhaemoglobin, oxyhaemoglobin and tissue oxygenation index at six weeks
timeFrame: Pre intervention and 6 weeks post intervention
Secondary outcomes:
measure: Change from baseline normalized EMG at 6 weeks
timeFrame: Pre intervention, 3 weeks post intervention and 6 weeks post intervention
Other outcomes:
measure: Change from baseline pain thresholds at 6 weeks
timeFrame: Pre intervention, 3 weeks post intervention and 6 weeks post intervention
measure: Change from baselien Neck Desability Index at 6 weeks
timeFrame: Pre intervention, 3 weeks post intervention and 6 weeks post intervention
measure: Change from Visual Analog Scale at 6 weeks
timeFrame: Pre intervention, 3 weeks post intervention and 6 weeks post intervention
Locations:
city: Florianópolis
country: Brazil
facility: Santa Catarina State University
state: Santa Catarina
Study officials:
affiliation: Santa Catarina State University
name: Gilmar M Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References: