Temporomandibular JointPhase 1NCT00870922
Effects of Masseter Manual Therapy on Temporomandibular Dysfunction
A Phase 1 study testing Active release techniques in people with Temporomandibular Joint and Temporomandibular Joint Dysfunction Syndrome, run by Logan College of Chiropractic at 1 site in United States.
Trial summary
Muscles and myofascial dysfunction are more often the mechanism and source of pain in oral fascial disorders (OFD) than the TMJ. Masticatory muscles in patients with TMJ alterations are more hypertonic, less efficient and more prone to fatigue compared to age and sex matched controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Joint, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Disorder
- What is being tested?
- Active release techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to May 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Difficulty and/or pain when opening mouth
- Jaw locking
- Difficulty or pain when chewing or talking
- TMJ clicking
- Jaw stiffness, tightness, or fatigue
- Pain in ear, temple or cheeks
- Frequent headaches, neckaches, toothaches
- Change in occlusion
Who cannot join
- Trauma to head, neck or jaw within last 12 months
- Recent dental extractions
- Taking prescription analgesics/muscle relaxants
- Recent cervical SMT (HVLA)
- Already under care for condition
- Sinus infection
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Logan University, College of Chiropractic
Chesterfield, Missouri, 63017
About this study
Official title: Effects of Masseter Manual Therapy on Temporomandibular Dysfunction: A Pilot Study
Muscles and myofascial dysfunction are more often the mechanism and source of pain in oral fascial disorders (OFD) than the TMJ. Masticatory muscles in patients with TMJ alterations are more hypertonic, less efficient and more prone to fatigue compared to age and sex matched controls. It is our opinion that Active Release Technique can be a reliable assessment and treatment tool in the resolution in cervical-cranio mandibular disorders. Our goal is to improve masticatory function through treatment of trigger points in the masseter.
Read the detailed description
Recruit 45 patients with TMD determined by questionnaire. Measure pre and post mandibular active range of motion and VAS pain scale. Treatment will include 4 visits over a two week span measuring before first treatment and after last treatment. There will be 3 treatment groups; active release technique, post isometric relaxation and a no treatment control group. We will analyze data for any change in mandibular range of motion and VAS pain scale.
- Conditions
- Temporomandibular Joint, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Disorder
- Being tested
- Active release techniques
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active release techniquesProcedure or surgery
Participants will receive ART and have Therabite (mouth opening) and pain (VAS) measured before and after ART
| Study group | Role | What they receive |
|---|---|---|
| TMD group | Experimental | Participants will receive ART and have Therabite (mouth opening) and pain (VAS) measured before and after ART Receives: Procedure: Active release techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Measured: 2 weeks
Secondary outcomes (1)
VAS pain scale
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular JointStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870922
- Sponsor's protocol ID
- SR0204090171
- Other IDs
- 388
- Status last verified
- Mar 2009
- First submitted
- 25 Mar 2009
- Last updated
- 27 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Masseter Manual Therapy on Temporomandibular Dysfunction: A Pilot Study
- ClinicalTrials.gov ID
- NCT00870922
- Acronym / sponsor ID
- SR0204090171
- Conditions
- Temporomandibular Joint, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 27 Mar 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.
Muscles and myofascial dysfunction are more often the mechanism and source of pain in oral fascial disorders (OFD) than the TMJ. Masticatory muscles in patients with TMJ alterations are more hypertonic, less efficient and more prone to fatigue compared to age and sex matched controls. It is our opinion that Active Release Technique can be a reliable assessment and treatment tool in the resolution in cervical-cranio mandibular disorders. Our goal is to improve masticatory function through treatment of trigger points in the masseter.
Detailed description
Recruit 45 patients with TMD determined by questionnaire. Measure pre and post mandibular active range of motion and VAS pain scale. Treatment will include 4 visits over a two week span measuring before first treatment and after last treatment. There will be 3 treatment groups; active release technique, post isometric relaxation and a no treatment control group. We will analyze data for any change in mandibular range of motion and VAS pain scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMD group | Experimental | Procedure: Active release techniquesParticipants will receive ART and have Therabite (mouth opening) and pain (VAS) measured before and after ART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Difficulty and/or pain when opening mouth
- Jaw locking
- Difficulty or pain when chewing or talking
- TMJ clicking
- Jaw stiffness, tightness, or fatigue
Key exclusion criteria (6 listed)
- Trauma to head, neck or jaw within last 12 months
- Recent dental extractions
- Taking prescription analgesics/muscle relaxants
- Recent cervical SMT (HVLA)
- Already under care for condition
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 |
|---|---|---|
| Active release techniquesParticipants will receive ART and have Therabite (mouth opening) and pain (VAS) measured before and after ART | Procedure or surgery | TMD group |
Primary outcome
Range of Motion
Time frame: 2 weeks
1 secondary outcome
VAS pain scale
Time frame: 2 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Active release techniques in people with Temporomandibular Joint and Temporomandibular Joint Dysfunction Syndrome, run by Logan College of Chiropractic at 1 site in United States.
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 8 inclusion and 6 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 27 Mar 2009. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James George, DC (636-230-1938 ext. 1938, james.george@logan.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: 2 weeks). 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 Mar 2009.