Temporomandibular DisordersPhase 1StretchingNCT00993577
Stretching Exercises and Temporomandibular Disorders
A Phase 1 study testing Stretching exercises and Exercises in people with Temporomandibular Disorders, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
Trial summary
To compare the efficacy of global postural reeducation (GPR) with static stretching exercises (SS) in the treatment of women with temporomandibular disorders (TMD). Physical therapy is of importance in the treatment of myogenic temporomandibular disorders (TMD). Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- Stretching exercises and Exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesBrazil
- Study dates
- Feb 2004to Mar 2007
- Phase
- Phase 1
- 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 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Helkimo index III,
- Myogenic TMD, AND
- Presence of para-functional habits, such as: bruxism, teeth clenching, mouth-breathing and lip biting.
Who cannot join
- Surgery or trauma in the orofacial region,
- Systemic or degenerative diseases, OR
- Undergoing odontological, psychological, or physical therapy treatments.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Physicaltherapy, Speech and Ocupational Therapy Department
Rua Cipotânea, 51, São Paulo
Clinical Hospital of University of São Paulo
São Paulo, São Paulo, 05403-000
About this study
Official title: Global Postural Reeducation and Static Stretching Exercises in the Treatment of Myogenic Temporomandibular Disorders. A Randomized Study
To compare the efficacy of global postural reeducation (GPR) with static stretching exercises (SS) in the treatment of women with temporomandibular disorders (TMD).
Physical therapy is of importance in the treatment of myogenic temporomandibular disorders (TMD). Both stretching exercise and global posture reeducation are equally effective in the treatment of TMD.
Read the detailed description
Purpose: To compare the efficacy of global postural reeducation (GPR) with static stretching exercises (SS) in the treatment of women with temporomandibular disorders (TMD).
Methods: A total of 24 subjects with TMD were randomized into two treatment groups: GPR, where therapy involved muscle global chain stretching, or SS, with conventional static stretching. Eight treatment sessions lasting 40 minutes each (weekly) were performed. Assessments were conducted at baseline, immediately after treatment end, and again two months later. Measurements included pain intensity at the temporomandibular joint, headache, cervicalgia (visual analogue scale - VAS) and teeth clenching. Additionally, electromyographic activity and pain thresholds were measured at the masseter, anterior temporalis, sternocleidomastoid, and upper trapezius muscles. Two-way analysis of variance (ANOVA) with Tukey post-hoc test was used for in-between group comparisons. Significance level was 0.05.
- Conditions
- Temporomandibular Disorders
- Being tested
- Stretching exercises, Exercises
- Keywords
- Stretching, Pain
- Medical subject headings
- Temporomandibular Joint Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching exercisesOther
Also called Global Postural Reeducation, Static Stretching Exercises
Treatment consisted of eight individual sessions (once a week), over two months. At the first 10 minutes of sessions, patients rested (supine position) with all limbs relaxed. Manual therapy maneuvers were made as described by Bienfait,17 associated to breathing exercises, in order to stretch the fasciae that recover the shoulders, as well as the cervical spine muscles. After that, stretching treatment (global or static) was conducted for another 30 minutes.
Stretching exercisesDevice
Also called Global Postural Reeducation, Static Stretching Exercises
Treatment consisted of eight individual sessions (once a week), over two months. At the first 10 minutes of sessions, patients rested (supine position) with all limbs relaxed. Manual therapy maneuvers were made as described by Bienfait,17 associated to breathing exercises, in order to stretch the fasciae that recover the shoulders, as well as the cervical spine muscles. After that, stretching treatment (global or static) was conducted for another 30 minutes.
ExercisesDevice
Also called Muscle stretching exercises, Pain measurement, Temporomandibular joint.
Treatment consisted of eight individual sessions (once a week), over two months. At the first 10 minutes of sessions, patients rested (supine position) with all limbs relaxed. Manual therapy maneuvers were made as described by Bienfait,17 associated to breathing exercises, in order to stretch the fasciae that recover the shoulders, as well as the cervical spine muscles. After that, stretching treatment (global or static) was conducted for another 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Exercises | Experimental | Global Postural Reeducation Static Stretching Exercises Receives: Other: Stretching exercises; Device: Stretching exercises; Device: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: 2
Secondary outcomes (1)
Quality of life
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startFeb 2004
- Primary completionJul 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993577
- Sponsor's protocol ID
- 155/04
- Acronym
- Stretching
- Status last verified
- Oct 2009
- First submitted
- 9 Oct 2009
- Last updated
- 30 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Postural Reeducation and Static Stretching Exercises in the Treatment of Myogenic Temporomandibular Disorders. A Randomized Study
- ClinicalTrials.gov ID
- NCT00993577
- Acronym / sponsor ID
- Stretching / 155/04
- Conditions
- Temporomandibular Disorders
- Keywords
- Stretching, Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 12 Oct 2009 (estimated)
- 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.
To compare the efficacy of global postural reeducation (GPR) with static stretching exercises (SS) in the treatment of women with temporomandibular disorders (TMD).
Physical therapy is of importance in the treatment of myogenic temporomandibular disorders (TMD). Both stretching exercise and global posture reeducation are equally effective in the treatment of TMD.
Detailed description
Purpose: To compare the efficacy of global postural reeducation (GPR) with static stretching exercises (SS) in the treatment of women with temporomandibular disorders (TMD).
Methods: A total of 24 subjects with TMD were randomized into two treatment groups: GPR, where therapy involved muscle global chain stretching, or SS, with conventional static stretching. Eight treatment sessions lasting 40 minutes each (weekly) were performed. Assessments were conducted at baseline, immediately after treatment end, and again two months later. Measurements included pain intensity at the temporomandibular joint, headache, cervicalgia (visual analogue scale - VAS) and teeth clenching. Additionally, electromyographic activity and pain thresholds were measured at the masseter, anterior temporalis, sternocleidomastoid, and upper trapezius muscles. Two-way analysis of variance (ANOVA) with Tukey post-hoc test was used for in-between group comparisons. Significance level was 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercises | Experimental | Other: Stretching exercises, Device: Stretching exercises, Device: ExercisesGlobal Postural Reeducation Static Stretching Exercises |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Helkimo index III,
- Myogenic TMD, AND
- Presence of para-functional habits, such as: bruxism, teeth clenching, mouth-breathing and lip biting.
Key exclusion criteria (3 listed)
- Surgery or trauma in the orofacial region,
- Systemic or degenerative diseases, OR
- Undergoing odontological, psychological, or physical therapy treatments.
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 |
|---|---|---|
| Stretching exercisesAlso: Global Postural Reeducation, Static Stretching ExercisesTreatment consisted of eight individual sessions (once a week), over two months. At the first 10 minutes of sessions, patients rested (supine position) with all limbs relaxed. Manual therapy maneuvers were made as described by Bienfait,17 associated to breathing exercises, in order to stretch the fasciae that recover the shoulders, as well as the cervical spine muscles. After that, stretching treatment (global or static) was conducted for another 30 minutes. | Other | Exercises |
| Stretching exercisesAlso: Global Postural Reeducation, Static Stretching ExercisesTreatment consisted of eight individual sessions (once a week), over two months. At the first 10 minutes of sessions, patients rested (supine position) with all limbs relaxed. Manual therapy maneuvers were made as described by Bienfait,17 associated to breathing exercises, in order to stretch the fasciae that recover the shoulders, as well as the cervical spine muscles. After that, stretching treatment (global or static) was conducted for another 30 minutes. | Device | Exercises |
| ExercisesAlso: Muscle stretching exercises, Pain measurement, Temporomandibular joint.Treatment consisted of eight individual sessions (once a week), over two months. At the first 10 minutes of sessions, patients rested (supine position) with all limbs relaxed. Manual therapy maneuvers were made as described by Bienfait,17 associated to breathing exercises, in order to stretch the fasciae that recover the shoulders, as well as the cervical spine muscles. After that, stretching treatment (global or static) was conducted for another 30 minutes. | Device | Exercises |
Primary outcome
Pain
Time frame: 2
1 secondary outcome
Quality of life
Time frame: 2
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 30 Oct 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stretching exercises and Exercises in people with Temporomandibular Disorders, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
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 3 inclusion and 3 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 30 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain (time frame: 2). 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 30 Oct 2009.