BruxismNCT05751694
Effectiveness of Visceral Manual Therapy in Bruxist Patients
A study testing Visceral manual treatment and Respiratory listening in people with Bruxism, run by University of Seville at 1 site in Spain.
Trial summary
Objective: check the effectiveness of visceral manual therapy on bruxist patients Design: Experimental, analytical, longitudinal, prospective, randomized, single-blind study with a blinded evaluator. Subjects: 68 subjects over 18 years old, with bruxism (diagnoses by a dentist). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bruxism
- What is being tested?
- Visceral manual treatment and Respiratory listening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 1 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with bruxism diagnosed and referred by a dentist
- Age: older than 18 years-old.
Who cannot join
- Recent craniofacial, mandibular or cervical trauma or fracture.
- Temporomandibular joint surgery.
- Acute pain due to other components of the masticatory system (caries, inflammation of the dental root).
- Abdominal surgery.
- Gastric ulcers.
- Gastritis.
Show all 17Show fewer
- Previous or current gastric neoplasm.
- Neurological or systemic diseases.
- Pregnant, including the period of breastfeeding.
- Patients receiving chemotherapy or radiotherapy.
- Cognitive, psychosomatic or psychiatric illnesses that may affect the data obtained.
- Basic systemic disease of rheumatic origin (for example, arthritis, osteoarthritis, gout and psoriasis).
- Cerebrovascular and brain diseases.
- Arrhythmia and other cardiac problems.
- Implanted electronic devices.
- Drug or alcohol abuse, analgesic or sedative therapy, and use of medications that affect the central nervous system (for example, antidepressants, anxiolytics, and anticonvulsants).
- Patients who have previous experience with manual treatment of the diaphragm
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Nursing, Physiotherapy and Podiatry Faculty
Seville, Spain, 41009
Lourdes María Fernández-Seguín, PhD
About this study
Objective: check the effectiveness of visceral manual therapy on bruxist patients Design: Experimental, analytical, longitudinal, prospective, randomized, single-blind study with a blinded evaluator.
Subjects: 68 subjects over 18 years old, with bruxism (diagnoses by a dentist). Methods: Subjects will be randomized into 2 groups: an experimental group (EG) to which a visceral manual technique will be applied and a control group (CG) to which a placebo manual technique will be administered. Both groups will receive 2 interventions one week apart. The measurements will be made before and after the interventions, and a last measurement will be made one month after the last intervention. Therefore, the patient will visit the center 3 times.
- Conditions
- Bruxism
- Being tested
- Visceral manual treatment, Respiratory listening
- Keywords
- Bruxism, Musculoskeletal Manipulations, Physical Therapy Modalities, Autonomic Nervous System
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visceral manual treatmentProcedure or surgery
The patient will be placed in a reclining sitting position and triple flexion of the lower limbs to keep the abdominal region relaxed. The therapist will be placed to the right of the patient at the height of the abdomen, with the hands placed in the epigastric area. He will make a skin fold that reduces tension in the area, so that the contact is focused on the visceral tissue of the area. The patient will be asked to take deep breaths, and during the exhalation, the therapist will perform a zigzag movement with vibration of the hands while pulling the tissue caudally. This procedure will be performed for 5 minutes.
Respiratory listeningProcedure or surgery
The patient and the therapist will be placed in the same position as in the experimental group. The therapist will place his hands in contact with the lower rib cage, and the patient will be asked to take a deep breath. The therapist will not exert any pressure, nor place restrictions on the tissues or movements of the ribcage.
| Study group | Role | What they receive |
|---|---|---|
| Visceral manual treatment | Experimental | The objective of this technique is to reduce the tension of the tissues of the epigastric area. Receives: Procedure: Visceral manual treatment |
| Respiratory listening | Active comparator | It is a maneuver to evaluate the mobility of the ribs during respiration. Receives: Procedure: Respiratory listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold (PPT) Baseline-1
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Baseline pre-intervention
PPT Change-1
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Change from "PTT Baseline-1" immediately post-intervention
PPT Baseline-2
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Baseline pre-intervention at 7 days
PPT Change-2
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Change from "PTT Baseline-2" immediately post-intervention
PPT Change-3
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Change from "PTT Baseline-2" and "PTT Change-2" at 1 month
Heart Rate Variability (HRV) Baseline-1
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
Measured: Baseline pre-intervention
HRV Change-1
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
Measured: Change from "HRV baseline-1" inmediately post-intervention
HRV Baseline-2
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
Measured: Baseline pre-intervention at 7 days
HRV Change-2
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
Measured: Change from "HRV baseline-2" inmediately post-intervention
HRV Change-3
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
Measured: Change from "HRV baseline-2" and "HRV change-2" at 1 month
Myotonometry baseline-1
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Baseline pre-intervention
Myotonometry change-1
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Change from "myotonometry baseline-1" inmediately post-intervention
Myotonometry baseline-2
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Baseline pre-intervention at 7 days
Myotonometry change-2
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Change from "myotonometry baseline-2" inmediately post-intervention
Myotonometry change-3
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Change from "myotonometry baseline-2" and "myotonometry change-2" at 1 month
Secondary outcomes (14)
Cervical Range of Motion (CROM) Baseline-1
The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Baseline pre-intervention
Cervical Range of Motion (CROM) Change-1
The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Change from "CROM Baseline-1" immediately post-intervention
Cervical Range of Motion (CROM) Baseline-2
The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Baseline pre-intervention at 7 days
Cervical Range of Motion (CROM) Change-2
The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Change from "CROM Baseline-2" immediately post-intervention
Cervical Range of Motion (CROM) Change-3
The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Change from "CROM Baseline-2" and "CROM Change-2" at 1 month
Perceived Stress Scale (PSS-14) Baseline
Perceived Stress Scale evaluates the level of perceived stress during the last month and consists of 14 items. The maximum score is 56 points. A higher score corresponds to a higher level of perceived stress.
Measured: Baseline
PSS-14 Change
Perceived Stress Scale evaluates the level of perceived stress during the last month and consists of 14 items. The maximum score is 56 points. A higher score corresponds to a higher level of perceived stress.
Measured: Change from Baseline PSS-14 at 1 month
Mandibular Mobility Baseline-1
For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Baseline pre-intervention
Mandibular Mobility Change-1
For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Change from "Mandibular Mobility Baseline-1" immediately post-intervention
Mandibular Mobility Baseline-2
For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Baseline pre-intervention at 7 days
Mandibular Mobility Change-2
For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Change from "Mandibular Mobility Baseline-2" immediately post-intervention
Mandibular Mobility Change-3
For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Measured: Change from "Mandibular Mobility Baseline-2" and "Mandibular Mobility Change-2" at 1 month
Pittsburgh Sleep Quality Index (PSQI) Baseline
It is a tool used to assess the quality of sleep in the last month.It consists of 7 items that are rated on a scale of 0 to 3. An overall Pittsburgh Sleep Quality Index score greater than 5 produced diagnostic sensitivity and specificity in distinguishing good and poor sleepers.
Measured: Baseline
PSQI Change
It is a tool used to assess the quality of sleep in the last month.It consists of 7 items that are rated on a scale of 0 to 3. An overall Pittsburgh Sleep Quality Index score greater than 5 produced diagnostic sensitivity and specificity in distinguishing good and poor sleepers.
Measured: Change from Baseline PSQI at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lourdes María Fernández Seguín, University of Seville
- Investigators
- Lourdes M Fernández Seguín, PhD, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751694
- Sponsor's protocol ID
- 070223TDCNR
- Status last verified
- May 2024
- First submitted
- 8 Feb 2023
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Visceral Manual Therapy in Bruxist Patients
- ClinicalTrials.gov ID
- NCT05751694
- Acronym / sponsor ID
- 070223TDCNR
- Conditions
- Bruxism
- Keywords
- Bruxism, Musculoskeletal Manipulations, Physical Therapy Modalities, Autonomic Nervous System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 2 Mar 2023 (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.
Objective: check the effectiveness of visceral manual therapy on bruxist patients Design: Experimental, analytical, longitudinal, prospective, randomized, single-blind study with a blinded evaluator.
Subjects: 68 subjects over 18 years old, with bruxism (diagnoses by a dentist). Methods: Subjects will be randomized into 2 groups: an experimental group (EG) to which a visceral manual technique will be applied and a control group (CG) to which a placebo manual technique will be administered. Both groups will receive 2 interventions one week apart. The measurements will be made before and after the interventions, and a last measurement will be made one month after the last intervention. Therefore, the patient will visit the center 3 times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visceral manual treatment | Experimental | Procedure: Visceral manual treatmentThe objective of this technique is to reduce the tension of the tissues of the epigastric area. |
| Respiratory listening | Active comparator | Procedure: Respiratory listeningIt is a maneuver to evaluate the mobility of the ribs during respiration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with bruxism diagnosed and referred by a dentist
- Age: older than 18 years-old.
Key exclusion criteria (17 listed)
- Recent craniofacial, mandibular or cervical trauma or fracture.
- Temporomandibular joint surgery.
- Acute pain due to other components of the masticatory system (caries, inflammation of the dental root).
- Abdominal surgery.
- Gastric ulcers.
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 |
|---|---|---|
| Visceral manual treatmentThe patient will be placed in a reclining sitting position and triple flexion of the lower limbs to keep the abdominal region relaxed. The therapist will be placed to the right of the patient at the height of the abdomen, with the hands placed in the epigastric area. He will make a skin fold that reduces tension in the area, so that the contact is focused on the visceral tissue of the area. The patient will be asked to take deep breaths, and during the exhalation, the therapist will perform a zigzag movement with vibration of the hands while pulling the tissue caudally. This procedure will be performed for 5 minutes. | Procedure or surgery | Visceral manual treatment |
| Respiratory listeningThe patient and the therapist will be placed in the same position as in the experimental group. The therapist will place his hands in contact with the lower rib cage, and the patient will be asked to take a deep breath. The therapist will not exert any pressure, nor place restrictions on the tissues or movements of the ribcage. | Procedure or surgery | Respiratory listening |
Primary outcome
Pressure pain threshold (PPT) Baseline-1
Time frame: Baseline pre-intervention
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
PPT Change-1
Time frame: Change from "PTT Baseline-1" immediately post-intervention
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
PPT Baseline-2
Time frame: Baseline pre-intervention at 7 days
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
PPT Change-2
Time frame: Change from "PTT Baseline-2" immediately post-intervention
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
PPT Change-3
Time frame: Change from "PTT Baseline-2" and "PTT Change-2" at 1 month
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Heart Rate Variability (HRV) Baseline-1
Time frame: Baseline pre-intervention
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
HRV Change-1
Time frame: Change from "HRV baseline-1" inmediately post-intervention
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
HRV Baseline-2
Time frame: Baseline pre-intervention at 7 days
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
HRV Change-2
Time frame: Change from "HRV baseline-2" inmediately post-intervention
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
HRV Change-3
Time frame: Change from "HRV baseline-2" and "HRV change-2" at 1 month
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
Myotonometry baseline-1
Time frame: Baseline pre-intervention
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Myotonometry change-1
Time frame: Change from "myotonometry baseline-1" inmediately post-intervention
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Myotonometry baseline-2
Time frame: Baseline pre-intervention at 7 days
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Myotonometry change-2
Time frame: Change from "myotonometry baseline-2" inmediately post-intervention
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Myotonometry change-3
Time frame: Change from "myotonometry baseline-2" and "myotonometry change-2" at 1 month
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
14 secondary outcomes
Cervical Range of Motion (CROM) Baseline-1
Time frame: Baseline pre-intervention
Cervical Range of Motion (CROM) Change-1
Time frame: Change from "CROM Baseline-1" immediately post-intervention
Cervical Range of Motion (CROM) Baseline-2
Time frame: Baseline pre-intervention at 7 days
Cervical Range of Motion (CROM) Change-2
Time frame: Change from "CROM Baseline-2" immediately post-intervention
Cervical Range of Motion (CROM) Change-3
Time frame: Change from "CROM Baseline-2" and "CROM Change-2" at 1 month
Perceived Stress Scale (PSS-14) Baseline
Time frame: Baseline
PSS-14 Change
Time frame: Change from Baseline PSS-14 at 1 month
Mandibular Mobility Baseline-1
Time frame: Baseline pre-intervention
Mandibular Mobility Change-1
Time frame: Change from "Mandibular Mobility Baseline-1" immediately post-intervention
Mandibular Mobility Baseline-2
Time frame: Baseline pre-intervention at 7 days
Mandibular Mobility Change-2
Time frame: Change from "Mandibular Mobility Baseline-2" immediately post-intervention
Mandibular Mobility Change-3
Time frame: Change from "Mandibular Mobility Baseline-2" and "Mandibular Mobility Change-2" at 1 month
Pittsburgh Sleep Quality Index (PSQI) Baseline
Time frame: Baseline
PSQI Change
Time frame: Change from Baseline PSQI at 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
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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.
Lourdes M Fernández Seguín, PhD principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visceral manual treatment and Respiratory listening in people with Bruxism, run by University of Seville 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 2 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 26 Feb 2025. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lourdes M Fernández Seguín, PhD (630258773 ext. +34, lfdez@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold (PPT) Baseline-1 (time frame: Baseline pre-intervention). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2025.