Clinical trial NCT04546490: Effects of Release and Ischemic Pressure of Trigger Points on Neck Pain. A Crossover, Controlled and Randomized Trial.
Official title: Effects of Pressure Release and Ischemic Pressure of Myofascial Trigger Points on Mechanical Neck Pain. A Crossover, Controlled and Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myofascial Trigger Point Pain
Myofascial Pain
Myofascial Pain Syndrome
Neck Pain
Keywords: Upper Trapezius Muscle
Manual therapy
Pressure Release Technique
Ischemic Pressure Technique
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* patients with neck pain in the last month

Exclusion Criteria:

* 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Before the intervention
measure: Visual Analog Scale
timeFrame: immediately after the intervention
measure: Pain Threshold at Pressure
timeFrame: Before the intervention
measure: Pain Threshold at Pressure
timeFrame: immediately after the intervention
measure: Northwick Park Questionary (Spanish Modified Version) for Cervical Spine disability
timeFrame: Before the intervention
measure: Northwick Park Questionary (Spanish Modified Version) for Cervical Spine disability
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Height
timeFrame: Before the first intervention
measure: Weight
timeFrame: Before the first intervention
measure: Age
timeFrame: Before the first intervention
measure: Sex
timeFrame: Before the first intervention
measure: Working Status
timeFrame: Before the first intervention
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Fisioterapia Los Molinos
state: Madrid
Study officials:
References: