Trapezius Muscle StrainNCT03882515
Evaluation Of Peripheral Muscle Oxygenation In Individuals With Muscular Idiopathic Pain With Myofascial Release
A study testing Myofascial Release, Continuous Surface Slip Technique and Without intervention in people with Trapezius Muscle Strain, run by University of the State of Santa Catarina at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trapezius Muscle Strain
- What is being tested?
- Myofascial Release, Continuous Surface Slip Technique and Without intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Aug 2017to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Catarina State University
Florianópolis, Santa Catarina, 88080350
About this study
Official title: 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.
Read the 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
- Being tested
- Myofascial Release, Continuous Surface Slip Technique, Without intervention
- Keywords
- Neck Pain, Fascia, Modalities of Physiotherapy, Oxygenation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial ReleaseOther
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.
Continuous Surface Slip TechniqueOther
- 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.
- 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.
- 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.
Without interventionOther
Evaluation and re-evaluation without intervention
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Evaluation of peripheral muscle oxygenation in individuals with muscular idiopathic pain before and after myofascial release Receives: 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 Receives: Other: Continuous Surface Slip Technique |
| Control group | Active comparator | Evaluation and reassessment of asymptomatic individuals Receives: Other: Without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Pre intervention and 6 weeks post intervention
Secondary outcomes (1)
Change from baseline normalized EMG at 6 weeks
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).
Measured: Pre intervention, 3 weeks post intervention and 6 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start31 Aug 2017
- Primary completion14 Mar 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trapezius Muscle StrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the State of Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilmar Moraes Santos, University of the State of Santa Catarina
- Investigators
- Gilmar M Santos, PhD, Principal investigator, Santa Catarina State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882515
- Sponsor's protocol ID
- Trapezium Spectroscopy
- Status last verified
- Sep 2019
- First submitted
- 7 Mar 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38335169
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Peripheral Muscle Oxygenation In Individuals With Muscular Idiopathic Pain Before And After Myofascial Release: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03882515
- Acronym / sponsor ID
- Trapezium Spectroscopy
- Conditions
- Trapezius Muscle Strain
- Keywords
- Neck Pain, Fascia, Modalities of Physiotherapy, Oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of the State of Santa CatarinaUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Myofascial ReleaseEvaluation of peripheral muscle oxygenation in individuals with muscular idiopathic pain before and after myofascial release |
| Sham group | Sham comparator | Other: Continuous Surface Slip TechniqueEvaluation of peripheral muscle oxygenation in individuals with muscular idiopathic pain before and after continuous surface slip technique |
| Control group | Active comparator | Other: Without interventionEvaluation and reassessment of asymptomatic individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Neurological diseases;
- History of trauma or cervical spine surgeries;
- Clinical diagnosis of hernia or nerve compression;
- Previous physiotherapy (last three months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofascial ReleaseWith 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. | Other | Experimental group |
| Continuous Surface Slip Technique1. 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. | Other | Sham group |
| Without interventionEvaluation and re-evaluation without intervention | Other | Control group |
Primary outcome
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).
1 secondary outcome
Change from baseline normalized EMG at 6 weeks
Time frame: Pre intervention, 3 weeks post intervention and 6 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 38335169Dos 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.
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Trapezius Muscle Strain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilmar M Santos, PhD principal investigator
Santa Catarina State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Release, Continuous Surface Slip Technique and Without intervention in people with Trapezius Muscle Strain, run by University of the State of Santa Catarina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline deoxyhaemoglobin, oxyhaemoglobin and tissue oxygenation index at six weeks (time frame: Pre intervention and 6 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03882515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.