Efficacy of Myofascial Induction as a Manual Therapy Technique in Patients With Anxiety

Study Overview
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Brief Summary
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This study evaluates the efficacy of a myofascial intervention as a technique within manual therapy in the treatment of clinical anxiety in adults. Half of the participants will receive a myofascial intervention program, while the other half will receive a sham myofascial intervention.

Detailed Description
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Within physiotherapy, some studies have been carried out with psychological outcome measures, mainly from therapeutic exercise, but there continues to be an important documentary gap and the few results are not conclusive. The myofascial approach is presented as an effective tool for the treatment of different pathologies, mainly musculoskeletal. However, few are the studies that relate it to psychological variables and specifically to improve anxiety levels. The myofascial approach is proposed as a fast and low-cost tool for the management of clinical anxiety.

Official Title
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Efficacy of Myofascial Induction as a Manual Therapy Technique in Patients With Anxiety. A Randomized Double Blind Clinical Trial Controlled With Placebo

Conditions
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Anxiety

Intervention / Treatment
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* Other: Myofascial treatment
* Other: Sham myofascial treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be between 18 and 65 years old Subjects with high levels of anxiety Subjects who speak and understand Spanish correctly Subjects without previous experience in myofascial treatment Exclusion Criteria: Subjects with a clinical history of cognitive impairment Subjects with systemic, neurological or muscular diseases Subjects with some type of aneurysm diagnosed Subjects with diagnosed extremely high blood pressure Subjects with diagnosed malignant tumors Subjects with diagnosed vertebrobasilar insufficiency Subjects with a diagnosed dermatological condition Subjects diagnosed with epilepsy Pregnant women or with the possibility that they may be

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized double blind clinical trial controlled with placebo in which neither the participants assigned to the groups nor the evaluators who measure the variables know to which group the subjects belong. To be part of the study, participants must obtain high scores in anxiety (STAI questionnaire). The calculation estimates a sample of 36 participants: 18 for the experimental group and 18 for the placebo group. Participants will be randomly assigned to the experimental group or the placebo group. In addition to anxiety levels before and after treatment, variables such as chronic pain, central sensitization, general health, somatization and depression will be measured.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myofascial treatment<br>4 sessions of myofascial intervention, 40 minutes per session, 1 session per week | Other: Myofascial treatment<br>* 40 minutes of myofascial intervention: 10 min in each of the following regions with the patient face up: Thoracolumbar fascia and abdomen C7-T4 and sternum Suboccipital area Temporary area<br>|
| Sham Comparator: Sham myofascial treatment<br>4 sessions of sham myofascial intervention, 40 minutes per session, 1 session per week | Other: Sham myofascial treatment<br>* 40 minutes of sham myofascial intervention: 10 min in each of the following regions with the patient face up and with the contact of the physiotherapist through a towel and without any intention: Thoracolumbar fascia and abdomen C7-T4 and sternum Suboccipital area Temporary area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory (STAI) | It consists of a self-report to evaluate two independent concepts about anxiety: anxiety as a state (in this moment) and anxiety as a trait (in most cases). Each of these subscales has a total of 20 items in a 4-point Likert response system according to intensity (0 = not at all; 3 = a lot). The total score in each of the subscales ranges from 0 to 60 points. | Change from baseline (pre-treatment), immediately after myofascial intervention (intrasession), through study completion (an average of 1 month), 3 and 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | It consists of a horizontal line of 10 centimeters, at the ends of which appear no pain and maximum pain. Patients mark where they would locate their intensity of chronic pain and later it is measured with a ruler indicating its result in millimeters. | Change from baseline (pre-treatment), immediately after myofascial intervention (intrasession), through study completion (an average of 1 month), 3 and 6 months follow-up | 
| Central Sensitization Inventory (CSI) | Self-report to identify symptoms related to a central sensitization. It consists of a total of 25 items in a 5-point response system according to intensity (0 = never; 4 = always). The total score ranges from 0 to 100. | Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up | 
| General Health Questionnaire (GHQ-12) | Questionnaire to evaluate general health. It consists of a total of 12 items (6 of them positive sentences and 6 negative sentences) in a 4-point response system according to intensity (0-3). The total score ranges from 0 to 36. | Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up | 
| Patient Health Questionnaire (PHQ-15) | Questionnaire to evaluate somatic symptoms. It consists of a total of 15 items in a 2-point response system according to intensity (0 = not at all; 2 = a lot). The total score ranges from 0 to 30. | Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up | 
| Beck Depression Inventory (BDI) | Self-report to evaluate depressive symptoms. It consists of a total of 21 items in a 3-point response system according to intensity (0 = not at all; 3 = a lot). The total score ranges from 0 to 63. | Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, myofascial induction, myofascial release, manual therapy, physiotherapy