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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04826302
• Other study ID #: MyofascialAnxiety
• Status: Completed
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: July 29, 2022

Study information

• Verified date: July 2022
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Myofascial treatment
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
• Sham myofascial treatment
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

Locations

Country	Name	City	State
Spain	Pulsion Fisioterapia	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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