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

Sponsor

Universidad Complutense de Madrid (Other)

Overall Status

Completed

CT.gov ID

NCT04826302

Collaborator

(none)

Enrollment

Location

Arms

15.3

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Other: Myofascial treatment Other: Sham myofascial treatment	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Outcomes Assessor)

Masking Description:

Patients will be assigned to two groups: Experimental group: who will receive myofascial intervention Control / placebo group: who will receive sham myofascial intervention Neither the participants assigned to the groups nor the evaluators who measure the variables know to which group the subjects belong. Participants will be randomly assigned through the GraphPad software.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 20, 2021

Actual Primary Completion Date :

Jul 29, 2022

Actual Study Completion Date :

Jul 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Myofascial treatment 4 sessions of myofascial intervention, 40 minutes per session, 1 session per week	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 Comparator: Sham myofascial treatment 4 sessions of sham myofascial intervention, 40 minutes per session, 1 session per week	Other: 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

Arm

Intervention/Treatment

Experimental: Myofascial treatment

4 sessions of myofascial intervention, 40 minutes per session, 1 session per week

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 Comparator: Sham myofascial treatment

4 sessions of sham myofascial intervention, 40 minutes per session, 1 session per week

Other: 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

Outcome Measures

Primary Outcome Measures

State-Trait Anxiety Inventory (STAI) [Change from baseline (pre-treatment), immediately after myofascial intervention (intrasession), through study completion (an average of 1 month), 3 and 6 months follow-up]
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.

Secondary Outcome Measures

Visual Analogue Scale (VAS) [Change from baseline (pre-treatment), immediately after myofascial intervention (intrasession), through study completion (an average of 1 month), 3 and 6 months follow-up]
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.
Central Sensitization Inventory (CSI) [Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up]
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.
General Health Questionnaire (GHQ-12) [Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up]
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.
Patient Health Questionnaire (PHQ-15) [Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up]
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.
Beck Depression Inventory (BDI) [Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pulsion Fisioterapia	Madrid		Spain	28028

Sponsors and Collaborators

Universidad Complutense de Madrid

Investigators

Principal Investigator: Rodrigo Gozalo Pascual, PT, Universidad Complutense de Madrid

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rodrigo Gozalo Pascual, Physical / Manual Therapist (PT, PhD Student), Biomechanics Professor, Universidad Complutense de Madrid

ClinicalTrials.gov Identifier:

NCT04826302

Other Study ID Numbers:

MyofascialAnxiety

First Posted:

Apr 1, 2021

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rodrigo Gozalo Pascual, Physical / Manual Therapist (PT, PhD Student), Biomechanics Professor, Universidad Complutense de Madrid

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Aug 2, 2022