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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myofascial treatment | Experimental | 4 sessions of myofascial intervention, 40 minutes per session, 1 session per week |
|
| Sham myofascial treatment | Sham Comparator | 4 sessions of sham myofascial intervention, 40 minutes per session, 1 session per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myofascial treatment | Other | 40 minutes of myofascial intervention: 10 min in each of the following regions with the patient face up:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | 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. | Change from baseline (pre-treatment), immediately after myofascial intervention (intrasession), through study completion (an average of 1 month), 3 and 6 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Gozalo Pascual, PT | Universidad Complutense de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulsion Fisioterapia | Madrid | 28028 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37004342 | Derived | 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. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089803 | Myofascial Release Therapy |
| ID | Term |
|---|---|
| D008405 | Massage |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
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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.
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Patients will be assigned to two groups:
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.
| 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:
|
|
| Central Sensitization Inventory (CSI) | 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. | Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up |
| General Health Questionnaire (GHQ-12) | 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. | Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up |
| Patient Health Questionnaire (PHQ-15) | 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. | Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up |
| Beck Depression Inventory (BDI) | 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. | Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |