Clinical trial NCT04826302: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: anxiety
myofascial induction
myofascial release
manual therapy
physiotherapy
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 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:
measure: Visual Analogue Scale (VAS)
timeFrame: Change from baseline (pre-treatment), immediately after myofascial intervention (intrasession), through study completion (an average of 1 month), 3 and 6 months follow-up
measure: Central Sensitization Inventory (CSI)
timeFrame: Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up
measure: General Health Questionnaire (GHQ-12)
timeFrame: Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up
measure: Patient Health Questionnaire (PHQ-15)
timeFrame: Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up
measure: Beck Depression Inventory (BDI)
timeFrame: Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Pulsion Fisioterapia
Study officials:
affiliation: Universidad Complutense de Madrid
name: Rodrigo Gozalo Pascual, PT
role: PRINCIPAL_INVESTIGATOR
References: