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

July 31, 2022 updated by: Rodrigo Gozalo Pascual, Universidad Complutense de Madrid

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28028
        • Pulsion Fisioterapia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Inventory (STAI)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up
General Health Questionnaire (GHQ-12)
Time Frame: 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.
Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up
Patient Health Questionnaire (PHQ-15)
Time Frame: 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.
Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up
Beck Depression Inventory (BDI)
Time Frame: 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.
Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2021

Primary Completion (ACTUAL)

July 29, 2022

Study Completion (ACTUAL)

July 29, 2022

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (ACTUAL)

April 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 31, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MyofascialAnxiety

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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