Temporomandibular Joint DisordersNCT01187316
Treatment of Temporomandibular Disorders
A study testing Transcutaneous electrical nerve stimulation and Physiotherapy in people with Temporomandibular Joint Disorders, run by University of Pernambuco at 2 sites in Brazil.
Trial summary
The aim of the present study was to carry out a pilot project comparing the effectiveness of two therapeutic approaches to temporomandibular disorders (TMDs) in adolescents. Eight female individuals diagnosed based on the Research Diagnosis Criteria for TMDs (RDC/TMD-axis 1)were randomly divided into two groups: 1)… Read more about this study
- Who is it for?
- Ages 14 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Transcutaneous electrical nerve stimulation and Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesBrazil
- Study dates
- Apr 2007to Sep 2007
- 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 14 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pain in orofacial area for at least 3 months
- Diagnosed at group 1 of RDC/TMD (myofascial pain with or without mouth opening limit)
Who cannot join
- Drug use for treatment of pain
- Functional limitations that would harm diagnosis
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Faculty of Dentistry of Pernambuco; Orofacial Control Center
Camaragibe, Pernambuco
Faculty of Dentistry of Pernambuco; Orofacial Control Center
Recife, Pernambuco
About this study
Official title: Massage and Transcutaneous Electrical Nerve Stimulation Therapies for Temporomandibular Disorders in Adolescents
The aim of the present study was to carry out a pilot project comparing the effectiveness of two therapeutic approaches to temporomandibular disorders (TMDs) in adolescents. Eight female individuals diagnosed based on the Research Diagnosis Criteria for TMDs (RDC/TMD-axis 1)were randomly divided into two groups: 1) Massage therapy and muscle stretching (n=4); and 2) transcutaneous electrical nerve stimulation (TENS) (n=4). Regardless the treatment, ten sessions were held for each patient and two measurements (baseline and 10th session) were performed for the assessment of symptom evolution using a visual analog scale (VAS), maximum opening of the mouth (MOM) and pressure pain threshold (PPT). Statistical analysis wiil be carefully selected.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Transcutaneous electrical nerve stimulation, Physiotherapy
- Keywords
- Facial Pain, Temporomandibular Joint Disorders, Transcutaneous Electric Nerve Stimulation, Adolescent
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulationDevice
Sensors were positioned on anterior temporal and masseter muscles bilaterally, and the stimulation was used for 20 minutes at 150 Hz and 100 µs of pulse width; intensity was adjusted individually.
PhysiotherapyOther
Massage and stretching of the anterior temporal and masseter muscle were performed by an experienced professional for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| TENS | Experimental | Not described Receives: Device: Transcutaneous electrical nerve stimulation |
| Massage therapy and muscle stretching | Active comparator | Not described Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
The subjects was asked to mark the intensity of the pain on a 100mm line, which was numbered from 0 to 10, being "0" = no pain, and 10 = to the worst pain ever felt. The outcome of pain intensity was given as a number marked by the patient.
Measured: Two times a week
Secondary outcomes (1)
Maximum mouth opening amplitude
Subjects were asked to open their mouths as much as they could and the opening amplitude was measured using a digital caliper.
Measured: Two times a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startApr 2007
- Primary completionAug 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Investigators
- Arnaldo F Caldas Junior, PhD, Principal investigator, University of PernambucoSilvia D Benevides, Ms, Study director, Federal University of BahiaMauricio Kosminsky, PhD, Study chair, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187316
- Sponsor's protocol ID
- 1-R6YV8
- Status last verified
- Mar 2007
- First submitted
- 23 Aug 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
List T, Wahlund K, Larsson B. Psychosocial functioning and dental factors in adolescents with temporomandibular disorders: a case-control study. J Orofac Pain. 2001 Summer;15(3):218-27.
PubMed 11575192Visscher CM, Lobbezoo F, Naeije M. Comparison of algometry and palpation in the recognition of temporomandibular disorder pain complaints. J Orofac Pain. 2004 Summer;18(3):214-9.
PubMed 15509000Rodrigues D, Siriani AO, Berzin F. Effect of conventional TENS on pain and electromyographic activity of masticatory muscles in TMD patients. Braz Oral Res. 2004 Oct-Dec;18(4):290-5. doi: 10.1590/s1806-83242004000400003.
PubMed 16089258Nilsson IM. Reliability, validity, incidence and impact of temporormandibular pain disorders in adolescents. Swed Dent J Suppl. 2007;(183):7-86.
PubMed 17506471
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massage and Transcutaneous Electrical Nerve Stimulation Therapies for Temporomandibular Disorders in Adolescents
- ClinicalTrials.gov ID
- NCT01187316
- Acronym / sponsor ID
- 1-R6YV8
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Facial Pain, Temporomandibular Joint Disorders, Transcutaneous Electric Nerve Stimulation, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 24 Aug 2010 (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 carry out a pilot project comparing the effectiveness of two therapeutic approaches to temporomandibular disorders (TMDs) in adolescents. Eight female individuals diagnosed based on the Research Diagnosis Criteria for TMDs (RDC/TMD-axis 1)were randomly divided into two groups: 1) Massage therapy and muscle stretching (n=4); and 2) transcutaneous electrical nerve stimulation (TENS) (n=4). Regardless the treatment, ten sessions were held for each patient and two measurements (baseline and 10th session) were performed for the assessment of symptom evolution using a visual analog scale (VAS), maximum opening of the mouth (MOM) and pressure pain threshold (PPT). Statistical analysis wiil be carefully selected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Device: Transcutaneous electrical nerve stimulation |
| Massage therapy and muscle stretching | Active comparator | Other: Physiotherapy |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pain in orofacial area for at least 3 months
- Diagnosed at group 1 of RDC/TMD (myofascial pain with or without mouth opening limit)
Key exclusion criteria (2 listed)
- Drug use for treatment of pain
- Functional limitations that would harm diagnosis
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 |
|---|---|---|
| Transcutaneous electrical nerve stimulationSensors were positioned on anterior temporal and masseter muscles bilaterally, and the stimulation was used for 20 minutes at 150 Hz and 100 µs of pulse width; intensity was adjusted individually. | Device | TENS |
| PhysiotherapyMassage and stretching of the anterior temporal and masseter muscle were performed by an experienced professional for 20 minutes. | Other | Massage therapy and muscle stretching |
Primary outcome
Pain
Time frame: Two times a week
The subjects was asked to mark the intensity of the pain on a 100mm line, which was numbered from 0 to 10, being "0" = no pain, and 10 = to the worst pain ever felt. The outcome of pain intensity was given as a number marked by the patient.
1 secondary outcome
Maximum mouth opening amplitude
Time frame: Two times a 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 25 Aug 2010.
- Background: PubMed 11575192List T, Wahlund K, Larsson B. Psychosocial functioning and dental factors in adolescents with temporomandibular disorders: a case-control study. J Orofac Pain. 2001 Summer;15(3):218-27.
- Background: PubMed 15509000Visscher CM, Lobbezoo F, Naeije M. Comparison of algometry and palpation in the recognition of temporomandibular disorder pain complaints. J Orofac Pain. 2004 Summer;18(3):214-9.
- Background: PubMed 16089258Rodrigues D, Siriani AO, Berzin F. Effect of conventional TENS on pain and electromyographic activity of masticatory muscles in TMD patients. Braz Oral Res. 2004 Oct-Dec;18(4):290-5. doi: 10.1590/s1806-83242004000400003.
- Background: PubMed 17506471Nilsson IM. Reliability, validity, incidence and impact of temporormandibular pain disorders in adolescents. Swed Dent J Suppl. 2007;(183):7-86.
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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.
Arnaldo F Caldas Junior, PhD principal investigator
University of Pernambuco
Silvia D Benevides, Ms study director
Federal University of Bahia
Mauricio Kosminsky, PhD study chair
University of Pernambuco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation and Physiotherapy in people with Temporomandibular Joint Disorders, run by University of Pernambuco 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 2 inclusion and 2 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 25 Aug 2010. 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.
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: Two times a week). 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 NCT01187316, which also lists 4 linked publications.
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 25 Aug 2010.