Herniated DiskNCT00936338
Randomized Clinical Trial of Treatment for Temporomandibular Joint (TMJ) Disc Displacement
A study testing splint and joint mobilization self exercise in people with Herniated Disk and Temporomandibular Disorders, run by Tokyo Medical and Dental University at 1 site in Japan.
Trial summary
The effectiveness of physical therapy for treatment of anterior disc displacement without reduction of temporomandibular disorders has not been well defined. This study compared the treatment method with conservative splint therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herniated Disk, Temporomandibular Disorders
- What is being tested?
- splint and joint mobilization self exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2006to Dec 2006
- 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
- Adult, Older adult
Who may be able to join
- (1) male or female over 18 years old;
- (2) with mouth opening pain on the TMJ affected side;
- (3) over two weeks after the onset of ADDwoR;
- (4) with maximum mouth opening of less than 40 mm; and
- (5) MRI-confirmed ADDwoR. The
Who cannot join
- (1) unwilling or unable to receive splint and/or exercise therapy;
- (2) with systemic bone or joint disease,
- (3) regular medication such as analgesics, anti-anxiety drugs, antidepressants and psychotropics; and
- (4) missing teeth and/or a removable denture but having a fixed partial denture restoration over one year.
Trial locations and contacts
1 site in 1 country.
About this study
The effectiveness of physical therapy for treatment of anterior disc displacement without reduction of temporomandibular disorders has not been well defined. This study compared the treatment method with conservative splint therapy. Fifty two subjects were assigned at random to either of two treatment groups: one is a splint treatment group, and the other is a joint mobilization self exercise group. Each treatment was evaluated using four outcome variables: (i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and (iv) limitation of daily activities. All outcome variables were significantly improved after eight-week of treatment in the exercise group. Meanwhile, the splint treatment improved three variables, other than "mouth opening with pain"; however, the degree of improvement was less than that seen in the exercise group. This result demonstrates that the joint mobilization self exercise improves jaw function and relieves pain as compared to the splint treatment.
- Conditions
- Herniated Disk, Temporomandibular Disorders
- Being tested
- splint and joint mobilization self exercise
- Keywords
- anterior disc displacement without reduction of temporomandibular disorders
- Medical subject headings
- Intervertebral Disc Displacement, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
splint and joint mobilization self exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| splint | Active comparator | Not described Receives: Behavioral: splint and joint mobilization self exercise |
| joint mobilization self exercise | Active comparator | Not described Receives: Behavioral: splint and joint mobilization self exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
(i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and (iv) limitation of daily activities
Measured: 0, 4 and 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJan 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniated DiskStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo Medical and Dental University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936338
- Sponsor's protocol ID
- 191
- Status last verified
- Jul 2009
- First submitted
- 9 Jul 2009
- Last updated
- 10 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Treatment for Temporomandibular Joint (TMJ) Disc Displacement
- ClinicalTrials.gov ID
- NCT00936338
- Acronym / sponsor ID
- 191
- Conditions
- Herniated Disk, Temporomandibular Disorders
- Keywords
- anterior disc displacement without reduction of temporomandibular disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tokyo Medical and Dental UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 10 Jul 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.
The effectiveness of physical therapy for treatment of anterior disc displacement without reduction of temporomandibular disorders has not been well defined. This study compared the treatment method with conservative splint therapy. Fifty two subjects were assigned at random to either of two treatment groups: one is a splint treatment group, and the other is a joint mobilization self exercise group. Each treatment was evaluated using four outcome variables: (i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and (iv) limitation of daily activities. All outcome variables were significantly improved after eight-week of treatment in the exercise group. Meanwhile, the splint treatment improved three variables, other than "mouth opening with pain"; however, the degree of improvement was less than that seen in the exercise group. This result demonstrates that the joint mobilization self exercise improves jaw function and relieves pain as compared to the splint treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| splint | Active comparator | Behavioral: splint and joint mobilization self exercise |
| joint mobilization self exercise | Active comparator | Behavioral: splint and joint mobilization self exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (1) male or female over 18 years old;
- (2) with mouth opening pain on the TMJ affected side;
- (3) over two weeks after the onset of ADDwoR;
- (4) with maximum mouth opening of less than 40 mm; and
- (5) MRI-confirmed ADDwoR. The
Key exclusion criteria (4 listed)
- (1) unwilling or unable to receive splint and/or exercise therapy;
- (2) with systemic bone or joint disease,
- (3) regular medication such as analgesics, anti-anxiety drugs, antidepressants and psychotropics; and
- (4) missing teeth and/or a removable denture but having a fixed partial denture restoration over one year.
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 |
|---|---|---|
| splint and joint mobilization self exercise | Behavioural | joint mobilization self exercise, splint |
Primary outcome
(i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and (iv) limitation of daily activities
Time frame: 0, 4 and 8 week
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 10 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing splint and joint mobilization self exercise in people with Herniated Disk and Temporomandibular Disorders, run by Tokyo Medical and Dental University at 1 site in Japan.
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 5 inclusion and 4 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 10 Jul 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 Japan. 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?
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?
(i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and (iv) limitation of daily activities (time frame: 0, 4 and 8 week). 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 10 Jul 2009.