Anxiety
Conditions
Keywords
anxiety, myofascial induction, myofascial release, manual therapy, physiotherapy
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.
Interventions
OTHERMyofascial 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
OTHERSham 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
Sponsors
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Spain
Outcome results
None listed