Temporomandibular Joint Dysfunction SyndromeNCT01954511
Manual Therapy and Exercises Applied to Cervical Spine in Patients With Temporomandibular Disorders
A study testing Manual therapy and Pressure biofeedback device in people with Temporomandibular Joint Dysfunction Syndrome, run by Universidade Federal de Sao Carlos.
Trial summary
The objective of this study was to investigate the effect of a manual therapy and exercise program, focused on the rehabilitation of cervical function, on clinical signs and mandibular function in subjects with TMD. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- Manual therapy and Pressure biofeedback device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Dec 2012
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients diagnosed with myogenic or mixed temporomandibular disorders
Who cannot join
- Patients diagnosed with arthrogenic or discogenic temporomandibular disorders
About this study
Official title: Effects of Manual Therapy and Exercises Applied to Cervical Spine in Patients With Temporomandibular Disorders: Pilot Study
The objective of this study was to investigate the effect of a manual therapy and exercise program, focused on the rehabilitation of cervical function, on clinical signs and mandibular function in subjects with TMD.
Read the detailed description
Temporomandibular disorder (TMD) is a general term that refers to disorders associated with the temporomandibular joint (TMJ) and the masticatory muscles. Among the main symptoms are pre-auricular pain (in the region of the TMJ) and/or pain in the masticatory muscles.
It's usual to observe that subjects with TMD also present cervical alteration. Beside this, cervical postural alterations produced by muscle tension can influence mandibular position.
The intervention protocol was based on manual therapy, stabilization exercises and stretching.
The technique are:.
- Upper cervical flexion mobilization;
- C5 central posterior-anterior mobilization;
- Stabilization exercise: Cranio-cervical flexor stabilization exercise
- Stretching of muscles: upper trapezius, scalenes, semispinalis capitis; splenius capitis, sternocleidomastoid
- Being tested
- Manual therapy, Pressure biofeedback device
- Keywords
- Stomatognathic diseases;, Temporomandibular Joint Dysfunction Syndrome
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome, Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
Also called Upper cervical flexion mobilization
The patient was supine with the cervical spine in a neutral position. The therapist brought about a contact of the occipital bone with the first finger and medial aspect of the hand, and other hand over the frontal region of the patient's head. The mobilizing force was delivered by flexing the upper cervical region using a combination of cephalic traction with the occipital hand and caudal pressure with the frontal hand. This technique was applied for 10 minutes
Manual therapyOther
Also called C5 central posterior-anterior mobilization
The patient was prone with the cervical spine in a neutral position. The therapist placed the tips of his thumbs on the posterior surface of the C5 spinous process, while the other fingers rested gently around the patients' neck. This technique was applied for 9 minutes
Pressure biofeedback deviceDevice
Also called Stabilizer
Device: Stabilizer - Chattanooga Group Inc., Chattanooga, Tennessee, USA The cranio-cervical flexor stabilization exercise was done 10 times holding 10 seconds the flexing position graded through feedback from a pressure biofeedback device
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy | No intervention | Upper cervical flexion mobilization, C5 central posterior-anterior mobilization, Pressure biofeedback device Receives: Other: Manual therapy; Device: Pressure biofeedback device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing in maximum mouth opening pain free
The clinical signs was based on Research Diagnostic Criteria protocol and it was measured maximum mouth opening pain free using a caliper ((Somet, 150mm, Inox, Czechoslovakia)
Measured: Before and 5 days follow-up intervetion
Secondary outcomes (1)
Changing of Pain
To evaluate pain it was applied a scale from Research Diagnostic Criteria protocol, that consists of a line scored from 0 to 10, where 0 represents no pain and 10 the worst pain that the subject has experienced, allowing it to check the number that features their pain at the moment.
Measured: Before and 5 days follow-up intervetion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Project was suspended for personal issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Dysfunction SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Leonardo da Silva Grüninger, Universidade Federal de Sao Carlos
- Investigators
- Ana Beatriz Oliveira, Phd, Study director, Clinical professor - UFSCarLetícia Bojikian Calixtre, Pt, Principal investigator, UFSCarFrancisco Alburquerque Sendín, Phd, Principal investigator, University of SalamancaMelina Nevoeiro Haik, MSc, Principal investigator, UFSCar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954511
- Sponsor's protocol ID
- U1111-1139-4055
- Other IDs
- 0300.0.135.000-11
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2013
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manual Therapy and Exercises Applied to Cervical Spine in Patients With Temporomandibular Disorders: Pilot Study
- ClinicalTrials.gov ID
- NCT01954511
- Acronym / sponsor ID
- U1111-1139-4055
- Keywords
- Stomatognathic diseases;, Temporomandibular Joint Dysfunction Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project was suspended for personal issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Oct 2013 (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.
The objective of this study was to investigate the effect of a manual therapy and exercise program, focused on the rehabilitation of cervical function, on clinical signs and mandibular function in subjects with TMD.
Detailed description
Temporomandibular disorder (TMD) is a general term that refers to disorders associated with the temporomandibular joint (TMJ) and the masticatory muscles. Among the main symptoms are pre-auricular pain (in the region of the TMJ) and/or pain in the masticatory muscles.
It's usual to observe that subjects with TMD also present cervical alteration. Beside this, cervical postural alterations produced by muscle tension can influence mandibular position.
The intervention protocol was based on manual therapy, stabilization exercises and stretching.
The technique are:.
- Upper cervical flexion mobilization;
- C5 central posterior-anterior mobilization;
- Stabilization exercise: Cranio-cervical flexor stabilization exercise
- Stretching of muscles: upper trapezius, scalenes, semispinalis capitis; splenius capitis, sternocleidomastoid
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | No intervention | Other: Manual therapy, Device: Pressure biofeedback deviceUpper cervical flexion mobilization, C5 central posterior-anterior mobilization, Pressure biofeedback device |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients diagnosed with myogenic or mixed temporomandibular disorders
Key exclusion criteria (1 listed)
- Patients diagnosed with arthrogenic or discogenic temporomandibular disorders
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 |
|---|---|---|
| Manual therapyAlso: Upper cervical flexion mobilizationThe patient was supine with the cervical spine in a neutral position. The therapist brought about a contact of the occipital bone with the first finger and medial aspect of the hand, and other hand over the frontal region of the patient's head. The mobilizing force was delivered by flexing the upper cervical region using a combination of cephalic traction with the occipital hand and caudal pressure with the frontal hand. This technique was applied for 10 minutes | Other | Manual therapy |
| Manual therapyAlso: C5 central posterior-anterior mobilizationThe patient was prone with the cervical spine in a neutral position. The therapist placed the tips of his thumbs on the posterior surface of the C5 spinous process, while the other fingers rested gently around the patients' neck. This technique was applied for 9 minutes | Other | Manual therapy |
| Pressure biofeedback deviceAlso: StabilizerDevice: Stabilizer - Chattanooga Group Inc., Chattanooga, Tennessee, USA The cranio-cervical flexor stabilization exercise was done 10 times holding 10 seconds the flexing position graded through feedback from a pressure biofeedback device | Device | Manual therapy |
Primary outcome
Changing in maximum mouth opening pain free
Time frame: Before and 5 days follow-up intervetion
The clinical signs was based on Research Diagnostic Criteria protocol and it was measured maximum mouth opening pain free using a caliper ((Somet, 150mm, Inox, Czechoslovakia)
1 secondary outcome
Changing of Pain
Time frame: Before and 5 days follow-up intervetion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
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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.
Ana Beatriz Oliveira, Phd study director
Clinical professor - UFSCar
Letícia Bojikian Calixtre, Pt principal investigator
UFSCar
Francisco Alburquerque Sendín, Phd principal investigator
University of Salamanca
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and Pressure biofeedback device in people with Temporomandibular Joint Dysfunction Syndrome, run by Universidade Federal de Sao Carlos.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Changing in maximum mouth opening pain free (time frame: Before and 5 days follow-up intervetion). 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 27 Sep 2019.