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

NCT04826302 | Completed

• 1 other identifier: MyofascialAnxiety
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

anxiety; myofascial induction; myofascial release; manual therapy; physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (5)

• 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

• Central Sensitization Inventory (CSI)

  Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up

• General Health Questionnaire (GHQ-12)

  Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up

• Patient Health Questionnaire (PHQ-15)

  Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up

• Beck Depression Inventory (BDI)

  Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up

Study Arms (2)

Myofascial treatment

EXPERIMENTAL

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

Other: Myofascial treatment

Sham myofascial treatment

SHAM COMPARATOR

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

Other: Sham myofascial treatment

Interventions

Myofascial treatment 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

Myofascial treatment

Sham myofascial treatment 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

Sham myofascial treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Pulsion Fisioterapia

Madrid, 28028, Spain

Location

Related Publications (1)

• 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.

  PMID: 37004342 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Rodrigo Gozalo Pascual, PT

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical / Manual Therapist (PT, PhD Student), Biomechanics Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Study Start: April 20, 2021
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

ES (1)