AnxietyNCT04826302
Efficacy of Myofascial Induction as a Manual Therapy Technique in Patients With Anxiety
A study testing Myofascial treatment in people with Anxiety, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Myofascial treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 20 Apr 2021to 29 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Subjects with a diagnosed dermatological condition
- Subjects diagnosed with epilepsy
- Pregnant women or with the possibility that they may be
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Myofascial Induction as a Manual Therapy Technique in Patients With Anxiety. A Randomized Double Blind Clinical Trial Controlled With Placebo
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Myofascial treatment, Sham myofascial treatment
- Keywords
- anxiety, myofascial induction, myofascial release, manual therapy, physiotherapy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial treatmentOther
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 treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Myofascial treatment | Experimental | 4 sessions of myofascial intervention, 40 minutes per session, 1 session per week Receives: Other: Myofascial treatment |
| Sham myofascial treatment | Sham comparator | 4 sessions of sham myofascial intervention, 40 minutes per session, 1 session per week Receives: Other: Sham myofascial treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline (pre-treatment), through study completion (an average of 1 month), 3 and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start20 Apr 2021
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Gozalo Pascual, Universidad Complutense de Madrid
- Investigators
- Rodrigo Gozalo Pascual, PT, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826302
- Sponsor's protocol ID
- MyofascialAnxiety
- Status last verified
- Jul 2022
- First submitted
- 25 Mar 2021
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37004342
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Myofascial Induction as a Manual Therapy Technique in Patients With Anxiety. A Randomized Double Blind Clinical Trial Controlled With Placebo
- ClinicalTrials.gov ID
- NCT04826302
- Acronym / sponsor ID
- MyofascialAnxiety
- Conditions
- Anxiety
- Keywords
- anxiety, myofascial induction, myofascial release, manual therapy, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Myofascial treatment | Experimental | Other: Myofascial treatment4 sessions of myofascial intervention, 40 minutes per session, 1 session per week |
| Sham myofascial treatment | Sham comparator | Other: Sham myofascial treatment4 sessions of sham myofascial intervention, 40 minutes per session, 1 session per week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofascial treatment40 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 | Other | Myofascial treatment |
| Sham myofascial treatment40 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 | Other | Sham myofascial treatment |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Derived from this study: PubMed 37004342Gozalo-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Gozalo Pascual, PT principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial treatment in people with Anxiety, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04826302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.