Myofascial Trigger Point PainNCT04546490
Effects of Release and Ischemic Pressure of Trigger Points on Neck Pain. A Crossover, Controlled and Randomized Trial.
A study testing Pressure Release technique and Ischemic pressure technique in people with Myofascial Trigger Point Pain and Myofascial Pain, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The aim of the study is to compare two manual therapy techniques. By testing if the Pressure Release of Myofascial Trigger Points technique (PRM) is more effective in treating Myofascial Trigger Points present in the upper trapezius muscle of patients with mechanical cervical pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Myofascial Trigger Point Pain, Myofascial Pain, Myofascial Pain Syndrome
- What is being tested?
- Pressure Release technique and Ischemic pressure technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2020to 25 Sep 2020
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with neck pain in the last month
Who cannot join
- Patients with recent surgeries of the upper quadrant or spine.
- Patients who are currently undergoing pharmacological or physiotherapeutic treatment.
- Patients who have suffered a recent traffic accident or other type of trauma
- Patients who are in the gestation period.
- Patients who have malignant neoplasms.
- Patients who do not sign the informed consent, do not understand the Spanish language or any other circumstance that would prevent their participation in this research will also be discarded
- Patients with no palpable active or latent myofascial trigger points in the upper trapezius muscle
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fisioterapia Los Molinos
Getafe, Madrid, 28906
Iván Batuecas, manager, +34699654655, ivanbatu@ucm.es
Iván Batuecas
About this study
Official title: Effects of Pressure Release and Ischemic Pressure of Myofascial Trigger Points on Mechanical Neck Pain. A Crossover, Controlled and Randomized Clinical Trial
The aim of the study is to compare two manual therapy techniques. By testing if the Pressure Release of Myofascial Trigger Points technique (PRM) is more effective in treating Myofascial Trigger Points present in the upper trapezius muscle of patients with mechanical cervical pain. This will be compared mainly with another manual therapy technique that presents evidences such as Ischemic Pressure technique (IP), and a control group, through the evaluation of the Visual Analogical Scale (VAS), the Threshold of Pain at Pressure (TPP) and the Northwick Park Questionnaire (NPC) of neck disability, spanish version.
Read the detailed description
The present pilot study is proposed as a crossover, controlled and randomized clinical trial, with blinded evaluation of response variables.
The aim of the study is to test whether the Pressure Release of Myofascial Trigger Points technique(PRM) is effective in treating Myofascial Trigger Points present in the upper trapezius muscle of patients with mechanical cervical pain. This will be compared mainly with another manual technique that presents more evidence such as Ischemic Pressure (IP), through the evaluation of the Visual Analogical Scale (VAS), the Threshold of Pain at Pressure (TPP) and the Northwick Park Questionnaire (NPC) of neck disability, Spanish version.
The patients, with a minimum sample for the pilot study of 30 subjects, of working age (18-50 years) with mechanical neck pain for at least the last month, will be recruited from the clinic "Fisioterapia Los Molinos" in the town of Getafe, the same place where the treatment will be carried out.
They will be randomly divided into three groups: one will be given Pressure Release of Myofascial Trigger Points technique (PRM), another Ischemic Pressure technique (IP), and a last one will be assigned as a control group. In compliance with the corresponding ethical criteria, the three groups will be subjected to random crossover so that no patient is left untreated. Visual Analogical Scale (VAS), Threshold of Pain at Pressure (TPP) and Northwick Park Questionnaire (NPC) of neck disability (spanish version), will be evaluated before and immediately after treatment.
Statistical analysis will be performed by IBM SPSS v22.0 program or a later version, verifying that the sample meets the criteria of normality and homogeneity and comparing the results of the variables through an ANOVA Analysis of variance.
- Being tested
- Pressure Release technique, Ischemic pressure technique
- Keywords
- Upper Trapezius Muscle, Manual therapy, Pressure Release Technique, Ischemic Pressure Technique
- Medical subject headings
- Myofascial Pain Syndromes, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Release techniqueOther
Manual therapy technique used by the treatment of Myofsacial Trigger points. The therapist will apply it with the first and second finger on the previously marked Myofascial Trigger Point and increasing the pressure as he perceives a reduction in the resistance offered by the soft tissue under the finger
Ischemic pressure techniqueOther
Manual therapy technique by making pressure in Myofascial Trigger Point. The therapist will apply it with the first and second finger on the previously marked Myofascial Trigger Point. This is performed until the patient's tolerance, when he refers a decrease in pain or have a correct adaptation to the perceived pain increase the pressure to a new painful barrier.
| Study group | Role | What they receive |
|---|---|---|
| Pressure release | Experimental | It will be applied with the patient in a supine position. The therapist will clamp his first and second fingers over the Myofascial Trigger Point located on the upper trapezium, it will be marked previously. The pressure will increase as the therapist perceives a reduction in the resistance offered by the soft tissue under his finger within a period of 90 seconds. Receives: Other: Pressure Release technique; Other: Ischemic pressure technique |
| Ischemic pressure | Experimental | Patient in supine position, the therapist performs pressure with first and second finger in PGM marked previously, this is performed until the patient tolerance, when the patient refers a decrease in pain or have a correct adaptation to the perceived pain increase the pressure to a new painful barrier. Repeat the process for 90 seconds. Receives: Other: Pressure Release technique; Other: Ischemic pressure technique |
| Control Group | No intervention | Patient in supine position on the stretcher, the therapist performs a clamp with the first and second finger on the upper trapezius muscle without making any pressure on it during 90 seconds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Place a mark in a chart according to the state of pain you are in at the moment, taking into account that the left extreme is the absence of pain and the opposite is the worst pain you may suffer
Measured: Before the intervention
Visual Analog Scale
Place a mark in a chart according to the state of pain you are in at the moment, taking into account that the left extreme is the absence of pain and the opposite is the worst pain you may suffer
Measured: immediately after the intervention
Pain Threshold at Pressure
Evaluated with a pressure algometer. It will be assessed with the subject in a comfortable position, back supported by the backrest, feet on the floor and arms relaxed. The algometer will be placed perpendicular to the previously marked Miofascial Trigger Point. Once it is in place, the pressure should be increased one kilogram by second until the patient begins to feel discomfort.
At this point the application will be stopped. Three measurements were made and the average will be calculated. Measured by Kilograms per square centimeter
Measured: Before the intervention
Pain Threshold at Pressure
Evaluated with a pressure algometer. It will be assessed with the subject in a comfortable position, back supported by the backrest, feet on the floor and arms relaxed. The algometer will be placed perpendicular to the previously marked Miofascial Trigger Point. Once it is in place, the pressure should be increased one kilogram by second until the patient begins to feel discomfort.
At this point the application will be stopped. Three measurements were made and the average will be calculated. Measured by Kilograms per square centimeter
Measured: immediately after the intervention
Northwick Park Questionary (Spanish Modified Version) for Cervical Spine disability
The questionnaire consists of nine questions related to pain intensity, sleep, weight load, leisure and social activities, work and driving. Each one of them presents five possible answers graduated from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability.
Measured: Before the intervention
Northwick Park Questionary (Spanish Modified Version) for Cervical Spine disability
The questionnaire consists of nine questions related to pain intensity, sleep, weight load, leisure and social activities, work and driving. Each one of them presents five possible answers graduated from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability.
Measured: immediately after the intervention
Secondary outcomes (5)
Height
Height of the subject
Measured: Before the first intervention
Weight
Weight of the subject
Measured: Before the first intervention
Age
Age of the subject
Measured: Before the first intervention
Sex
Sex of the subject
Measured: Before the first intervention
Working Status
Working status of the subject
Measured: Before the first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start15 Feb 2020
- Primary completion15 Sep 2020 (estimated)
- Study completion25 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Trigger Point PainStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Patients, aged 18-50 years with mechanical neck pain for at least the last month, will be randomly divided into three groups: one will be given Pressure Release technique, another Ischemic Pressure technique, and a last one will be assigned as a control group. They will be crosslinked after the first treatment. The variables will be evaluated before and immediately after treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iván Batuecas Sánchez, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546490
- Sponsor's protocol ID
- C.I. 20/090-E
- Status last verified
- Sep 2020
- First submitted
- 20 Aug 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pressure Release and Ischemic Pressure of Myofascial Trigger Points on Mechanical Neck Pain. A Crossover, Controlled and Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04546490
- Acronym / sponsor ID
- C.I. 20/090-E
- Keywords
- Upper Trapezius Muscle, Manual therapy, Pressure Release Technique, Ischemic Pressure Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 15 Sep 2020 (estimated)
- Study completion
- 25 Sep 2020 (estimated)
- First posted
- 14 Sep 2020 (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.
The aim of the study is to compare two manual therapy techniques. By testing if the Pressure Release of Myofascial Trigger Points technique (PRM) is more effective in treating Myofascial Trigger Points present in the upper trapezius muscle of patients with mechanical cervical pain. This will be compared mainly with another manual therapy technique that presents evidences such as Ischemic Pressure technique (IP), and a control group, through the evaluation of the Visual Analogical Scale (VAS), the Threshold of Pain at Pressure (TPP) and the Northwick Park Questionnaire (NPC) of neck disability, spanish version.
Detailed description
The present pilot study is proposed as a crossover, controlled and randomized clinical trial, with blinded evaluation of response variables.
The aim of the study is to test whether the Pressure Release of Myofascial Trigger Points technique(PRM) is effective in treating Myofascial Trigger Points present in the upper trapezius muscle of patients with mechanical cervical pain. This will be compared mainly with another manual technique that presents more evidence such as Ischemic Pressure (IP), through the evaluation of the Visual Analogical Scale (VAS), the Threshold of Pain at Pressure (TPP) and the Northwick Park Questionnaire (NPC) of neck disability, Spanish version.
The patients, with a minimum sample for the pilot study of 30 subjects, of working age (18-50 years) with mechanical neck pain for at least the last month, will be recruited from the clinic "Fisioterapia Los Molinos" in the town of Getafe, the same place where the treatment will be carried out.
They will be randomly divided into three groups: one will be given Pressure Release of Myofascial Trigger Points technique (PRM), another Ischemic Pressure technique (IP), and a last one will be assigned as a control group. In compliance with the corresponding ethical criteria, the three groups will be subjected to random crossover so that no patient is left untreated. Visual Analogical Scale (VAS), Threshold of Pain at Pressure (TPP) and Northwick Park Questionnaire (NPC) of neck disability (spanish version), will be evaluated before and immediately after treatment.
Statistical analysis will be performed by IBM SPSS v22.0 program or a later version, verifying that the sample meets the criteria of normality and homogeneity and comparing the results of the variables through an ANOVA Analysis of variance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients, aged 18-50 years with mechanical neck pain for at least the last month, will be randomly divided into three groups: one will be given Pressure Release technique, another Ischemic Pressure technique, and a last one will be assigned as a control group. They will be crosslinked after the first treatment. The variables will be evaluated before and immediately after treatment.
| Arm | Type | Receives |
|---|---|---|
| Pressure release | Experimental | Other: Pressure Release technique, Other: Ischemic pressure techniqueIt will be applied with the patient in a supine position. The therapist will clamp his first and second fingers over the Myofascial Trigger Point located on the upper trapezium, it will be marked previously. The pressure will increase as the therapist perceives a reduction in the resistance offered by the soft tissue under his finger within a period of 90 seconds. |
| Ischemic pressure | Experimental | Other: Pressure Release technique, Other: Ischemic pressure techniquePatient in supine position, the therapist performs pressure with first and second finger in PGM marked previously, this is performed until the patient tolerance, when the patient refers a decrease in pain or have a correct adaptation to the perceived pain increase the pressure to a new painful barrier. Repeat the process for 90 seconds. |
| Control Group | No intervention | –Patient in supine position on the stretcher, the therapist performs a clamp with the first and second finger on the upper trapezius muscle without making any pressure on it during 90 seconds |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with neck pain in the last month
Key exclusion criteria (7 listed)
- Patients with recent surgeries of the upper quadrant or spine.
- Patients who are currently undergoing pharmacological or physiotherapeutic treatment.
- Patients who have suffered a recent traffic accident or other type of trauma
- Patients who are in the gestation period.
- Patients who have malignant neoplasms.
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 |
|---|---|---|
| Pressure Release techniqueManual therapy technique used by the treatment of Myofsacial Trigger points. The therapist will apply it with the first and second finger on the previously marked Myofascial Trigger Point and increasing the pressure as he perceives a reduction in the resistance offered by the soft tissue under the finger | Other | Ischemic pressure, Pressure release |
| Ischemic pressure techniqueManual therapy technique by making pressure in Myofascial Trigger Point. The therapist will apply it with the first and second finger on the previously marked Myofascial Trigger Point. This is performed until the patient's tolerance, when he refers a decrease in pain or have a correct adaptation to the perceived pain increase the pressure to a new painful barrier. | Other | Ischemic pressure, Pressure release |
Primary outcome
Visual Analog Scale
Time frame: Before the intervention
Place a mark in a chart according to the state of pain you are in at the moment, taking into account that the left extreme is the absence of pain and the opposite is the worst pain you may suffer
Visual Analog Scale
Time frame: immediately after the intervention
Place a mark in a chart according to the state of pain you are in at the moment, taking into account that the left extreme is the absence of pain and the opposite is the worst pain you may suffer
Pain Threshold at Pressure
Time frame: Before the intervention
Evaluated with a pressure algometer. It will be assessed with the subject in a comfortable position, back supported by the backrest, feet on the floor and arms relaxed. The algometer will be placed perpendicular to the previously marked Miofascial Trigger Point. Once it is in place, the pressure should be increased one kilogram by second until the patient begins to feel discomfort. At this point the application will be stopped. Three measurements were made and the average will be calculated. Measured by Kilograms per square centimeter
Pain Threshold at Pressure
Time frame: immediately after the intervention
Evaluated with a pressure algometer. It will be assessed with the subject in a comfortable position, back supported by the backrest, feet on the floor and arms relaxed. The algometer will be placed perpendicular to the previously marked Miofascial Trigger Point. Once it is in place, the pressure should be increased one kilogram by second until the patient begins to feel discomfort. At this point the application will be stopped. Three measurements were made and the average will be calculated. Measured by Kilograms per square centimeter
Northwick Park Questionary (Spanish Modified Version) for Cervical Spine disability
Time frame: Before the intervention
The questionnaire consists of nine questions related to pain intensity, sleep, weight load, leisure and social activities, work and driving. Each one of them presents five possible answers graduated from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability.
Northwick Park Questionary (Spanish Modified Version) for Cervical Spine disability
Time frame: immediately after the intervention
The questionnaire consists of nine questions related to pain intensity, sleep, weight load, leisure and social activities, work and driving. Each one of them presents five possible answers graduated from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability.
5 secondary outcomes
Height
Time frame: Before the first intervention
Weight
Time frame: Before the first intervention
Age
Time frame: Before the first intervention
Sex
Time frame: Before the first intervention
Working Status
Time frame: Before the first intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure Release technique and Ischemic pressure technique in people with Myofascial Trigger Point Pain and Myofascial Pain, run by Universidad Complutense de Madrid at 1 site in Spain.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Sep 2020. 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 Spain. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Before the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.