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NCT Number: NCT04826302

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulsion Fisioterapia

Madrid, 28028, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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