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

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Other: Myofascial treatment; Other: Sham myofascial treatment

• Registration Number: NCT04826302
• Lead Sponsor: Universidad Complutense de Madrid

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.

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-04-20
• Status Verified: 2022-07
• Primary Completion: 2022-07-29
• Study Completion: 2022-07-29
• Last Update Submitted: 2022-07-31
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myofascial treatment	Myofascial treatment	4 sessions of myofascial intervention, 40 minutes per session, 1 session per week
Sham myofascial treatment	Sham myofascial treatment	4 sessions of sham myofascial intervention, 40 minutes per session, 1 session per week

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Pulsion Fisioterapia; 🇪🇸 Madrid, Spain