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

NCT ID: NCT04826302

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2022-07-29

Brief Summary

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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

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Myofascial treatment

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

Group Type EXPERIMENTAL

Myofascial treatment

Intervention Type OTHER

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

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

Group Type SHAM_COMPARATOR

Sham myofascial treatment

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Gozalo Pascual

Physical / Manual Therapist (PT, PhD Student), Biomechanics Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodrigo Gozalo Pascual, PT

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Locations

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Pulsion Fisioterapia

Madrid, , Spain

Site Status

Countries

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Spain

References

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Gozalo-Pascual R, Gonzalez-Ordi H, Atin-Arratibel MA, Llames-Sanchez J, Alvarez-Melcon AC. Efficacy of the myofascial approach as a manual therapy technique in patients with clinical anxiety: A randomized controlled clinical trial. Complement Ther Clin Pract. 2023 May;51:101753. doi: 10.1016/j.ctcp.2023.101753. Epub 2023 Mar 29.

Reference Type DERIVED
PMID: 37004342 (View on PubMed)

Other Identifiers

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MyofascialAnxiety

Identifier Type: -

Identifier Source: org_study_id

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