Efficacy of Myofascial Induction as a Manual Therapy Technique in Patients With Anxiety
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Myofascial treatment
Sham myofascial treatment
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring anxiety, myofascial induction, myofascial release, manual therapy, physiotherapy
Eligibility Criteria
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
Sites / Locations
- Pulsion Fisioterapia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Myofascial treatment
Sham myofascial treatment
Arm Description
4 sessions of myofascial intervention, 40 minutes per session, 1 session per week
4 sessions of sham myofascial intervention, 40 minutes per session, 1 session per week
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04826302
First Posted
March 25, 2021
Last Updated
July 31, 2022
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04826302
Brief Title
Efficacy of Myofascial Induction as a Manual Therapy Technique in Patients With Anxiety
Official Title
Efficacy of Myofascial Induction as a Manual Therapy Technique in Patients With Anxiety. A Randomized Double Blind Clinical Trial Controlled With Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety, myofascial induction, myofascial release, manual therapy, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Myofascial treatment
Arm Type
Experimental
Arm Description
4 sessions of myofascial intervention, 40 minutes per session, 1 session per week
Arm Title
Sham myofascial treatment
Arm Type
Sham Comparator
Arm Description
4 sessions of sham myofascial intervention, 40 minutes per session, 1 session per week
Intervention Type
Other
Intervention Name(s)
Myofascial treatment
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sham myofascial treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI)
Description
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.
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
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
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
Title
Central Sensitization Inventory (CSI)
Description
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.
Time Frame
Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up
Title
General Health Questionnaire (GHQ-12)
Description
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.
Time Frame
Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up
Title
Patient Health Questionnaire (PHQ-15)
Description
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.
Time Frame
Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up
Title
Beck Depression Inventory (BDI)
Description
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.
Time Frame
Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Gozalo Pascual, PT
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulsion Fisioterapia
City
Madrid
ZIP/Postal Code
28028
Country
Spain
12. IPD Sharing Statement
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Efficacy of Myofascial Induction as a Manual Therapy Technique in Patients With Anxiety
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