Temporomandibular Joint DisordersNCT01475630
Physical Therapy for Temporomandibular Joint (TMJ) Closed Lock
A study testing physical therapy in people with Temporomandibular Joint Disorders and Temporomandibular Joint Disc Displacement, Without Reduction, run by KU Leuven at 1 site in Belgium.
Trial summary
The aim of the present study was to investigate the effect of Physical Therapy (PT) on pain and mandibular function in patients with anterior disc displacement without reduction (ADD-R) or "closed lock" of the TMJ and this in a randomized controlled trial design. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Temporomandibular Joint Disorders, Temporomandibular Joint Disc Displacement, Without Reduction
- What is being tested?
- physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2003to Nov 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients were recruited from the Oral Pain and Dysfunction Clinic and strictly satisfied the RDC-TMD criteria for .for disc displacement without reduction with (group IIb) or without (group IIc) limitation of mouth opening, based upon history and clinical examination. Additionally, pain experienced during the first examination had to be ≥ 35mm on a visual analog scale (VAS) of 100mm.
Who cannot join
- Patients were excluded if their medical history mentioned orofacial traumata (contusion or fracture), systemic disorders (e.g. rheumatoid arthritis, fibromyalgia), cervical disorders (operationalized as complaints, pain or referral patterns of pain provoked during movements of the cervical spine), neurologic disorders (e.g. trigeminal neuralgia, migraine or tension type headache), drug or alcohol abuse, use of antidepressant or hormonal medication. Participants did not receive therapy for symptoms of TMD within the last 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial on Physical Therapy PT) for TMJ Closed Lock
The aim of the present study was to investigate the effect of Physical Therapy (PT) on pain and mandibular function in patients with anterior disc displacement without reduction (ADD-R) or "closed lock" of the TMJ and this in a randomized controlled trial design.
Read the detailed description
The study evaluated the effect of extra, technical PT over the traditional information on the benign nature of the disease and the advice to refrain from overuse or misuse of the masticatory system as in parafunctions.
- Conditions
- Temporomandibular Joint Disorders, Temporomandibular Joint Disc Displacement, Without Reduction
- Being tested
- physical therapy, control
- Keywords
- temporomandibular joint, rehabilitation medicine, joint diseases, physical therapy
- Medical subject headings
- Temporomandibular Joint Disorders, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapyProcedure or surgery
Also called physiotherapy
mobilisation of the jaw, exercises, boostering information on avoiding parafunctions
controlProcedure or surgery
Also called counseling, information
relaxation
| Study group | Role | What they receive |
|---|---|---|
| control | Other | information, avoiding parafunctions Receives: Procedure: control |
| physical therapy | Experimental | mobilisation, exercises ,.. Receives: Procedure: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
using VAS scales
Measured: 1 year
Secondary outcomes (3)
mouth opening
interincisal dstance measured by a ruler upon active and passive mouth opening
Measured: 1 year
pressure pain threshold
the pressure pain threshold was measured using an algometer at the masseter and temporalis muscles bilaterally
Measured: 1 year
mandibular function impairment questionnaire
Using a validated questionnaire the impact of the pain and limitaiton on normal masticatory function is monitored
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startJun 2003
- Primary completionJun 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof.dr. Antoon De Laat, KU Leuven
- Investigators
- Antoon De Laat, DDS,PhD, Principal investigator, Catholic University Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475630
- Sponsor's protocol ID
- ML2210
- Status last verified
- Nov 2011
- First submitted
- 17 Nov 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Craane B, Dijkstra PU, Stappaerts K, De Laat A. Randomized controlled trial on physical therapy for TMJ closed lock. J Dent Res. 2012 Apr;91(4):364-9. doi: 10.1177/0022034512438275. Epub 2012 Feb 8.
PubMed 22318373
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial on Physical Therapy PT) for TMJ Closed Lock
- ClinicalTrials.gov ID
- NCT01475630
- Acronym / sponsor ID
- ML2210
- Conditions
- Temporomandibular Joint Disorders, Temporomandibular Joint Disc Displacement, Without Reduction
- Keywords
- temporomandibular joint, rehabilitation medicine, joint diseases, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Jun 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 21 Nov 2011 (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 aim of the present study was to investigate the effect of Physical Therapy (PT) on pain and mandibular function in patients with anterior disc displacement without reduction (ADD-R) or "closed lock" of the TMJ and this in a randomized controlled trial design.
Detailed description
The study evaluated the effect of extra, technical PT over the traditional information on the benign nature of the disease and the advice to refrain from overuse or misuse of the masticatory system as in parafunctions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Other | Procedure: controlinformation, avoiding parafunctions |
| physical therapy | Experimental | Procedure: physical therapymobilisation, exercises ,.. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients were recruited from the Oral Pain and Dysfunction Clinic and strictly satisfied the RDC-TMD criteria for .for disc displacement without reduction with (group IIb) or without (group IIc) limitation of mouth opening, based upon history and clinical examination. Additionally, pain experienced during the first examination had to be ≥ 35mm on a visual analog scale (VAS) of 100mm.
Key exclusion criteria (1 listed)
- Patients were excluded if their medical history mentioned orofacial traumata (contusion or fracture), systemic disorders (e.g. rheumatoid arthritis, fibromyalgia), cervical disorders (operationalized as complaints, pain or referral patterns of pain provoked during movements of the cervical spine), neurologic disorders (e.g. trigeminal neuralgia, migraine or tension type headache), drug or alcohol abuse, use of antidepressant or hormonal medication. Participants did not receive therapy for symptoms of TMD within the last 2 months.
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 |
|---|---|---|
| physical therapyAlso: physiotherapymobilisation of the jaw, exercises, boostering information on avoiding parafunctions | Procedure or surgery | physical therapy |
| controlAlso: counseling, informationrelaxation | Procedure or surgery | control |
Primary outcome
pain intensity
Time frame: 1 year
using VAS scales
3 secondary outcomes
mouth opening
Time frame: 1 year
pressure pain threshold
Time frame: 1 year
mandibular function impairment questionnaire
Time frame: 1 year
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 22 Nov 2011.
- Derived from this study: PubMed 22318373Craane B, Dijkstra PU, Stappaerts K, De Laat A. Randomized controlled trial on physical therapy for TMJ closed lock. J Dent Res. 2012 Apr;91(4):364-9. doi: 10.1177/0022034512438275. Epub 2012 Feb 8.
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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.
Antoon De Laat, DDS,PhD principal investigator
Catholic University Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy in people with Temporomandibular Joint Disorders and Temporomandibular Joint Disc Displacement, Without Reduction, run by KU Leuven at 1 site in Belgium.
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: finished, as of the sponsor's last update on 22 Nov 2011. 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 Belgium. 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?
pain intensity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01475630, which also lists 1 linked publication.
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 22 Nov 2011.