Temporomandibular Joint DisordersNCT06035341
The Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction
A study testing Orofacial Manual Therapy in people with Temporomandibular Joint Disorders and Temporomandibular Disorder, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the relationship between Temporomandibular Disorders (TMD) and Sacroiliac Joint Disfunction (SIJD) and to determine the immediate effect of single-session orofacial manual therapy on SIJD. Patients will be treated for 1 session. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Temporomandibular Disorder
- What is being tested?
- Orofacial Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 15 Oct 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Volunteered to participate,
- Aged between 18-60 years old,
- Having the diagnosis of Temporomandibular Disorders (TMB) and sacroiliac joint disfunction (SIJD),
Who cannot join
- Having a malignant condition, trauma and surgery of the cranial and cervical region,
- Not being cooperative,
- Regular use of analgesic and anti-inflammatory drugs,
- Having dentofacial anomalies,
- Having active inflammatory arthritis,
- Having metabolic diseases (Gout, osteoporosis, Cushing's disease and hyper/hypo-parathyroidism),
Show all 9Show fewer
- Having connective tissue, rheumatological (Systemic lupus erythematosus and scleroderma) and hematological disorders (Anemia and leukemia),
- Having a diagnosed psychiatric illness,
- Receiving TMD-related physical therapy less than 6 months ago
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan İğrek
Istanbul, 34275
05372100654
About this study
Official title: Is There a Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction?
The aim of this study is to evaluate the relationship between Temporomandibular Disorders (TMD) and Sacroiliac Joint Disfunction (SIJD) and to determine the immediate effect of single-session orofacial manual therapy on SIJD. Patients will be treated for 1 session. The evaluation was planned to be done twice, at the beginning and end of the session.
Read the detailed description
The aim of this study is to evaluate the relationship between TMD and SIJD and to determine the immediate effect of single-session orofacial manual therapy on SIJD. Patients diagnosed with both TMD and SIJD will be participants of the study. Patients will be treated for 1 session. Immediately after the treatment, participants will be asked to walk for 5 minutes, after which a second assessment will be done. The evaluation was planned to be done twice, at the beginning and end of the session. Pressure pain threshold, joint range of motion, functionality, and sacroiliac joint disfunction will be evaluated by using digital algometer, ruler, "Oswestry Disability Index (ODI)" and specific tests respectively.
- Being tested
- Orofacial Manual Therapy
- Keywords
- Temporomandibular Joint Disorders, Temporomandibular Joint, Sacroiliac Joint, Orofacial Pain
- 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.
Orofacial Manual TherapyOther
As orofacial manual therapy, soft tissue (intraoral and extraoral trigger point therapy and myofascial release of painful muscles) and joint mobilization (caudal and ventro-caudal traction, ventral and mediolateral translation), muscle energy technique, fascia mandibularis release, occipital release and ligamentous treatment was planned.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants in this group will be received orofacial manual therapy as treatment. The number of participants is planned to be 23. Receives: Other: Orofacial Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Threshold: Digital algometer
The algometer is a reliable instrument for measuring the sensitivity of the masticatory muscles and 1 cm below the Posterior Superior Iliac Spine (PSIS). The measurement will be made at 10 points. A force (Newton in force) of 1 kg (weight in kilogram) per square centimeter (surface area in centimeter square) is applied to the patient for 3 seconds, and this is continued until the patient feels pain (weight and surface area will be combined to report Newton in kg/ cm2). This process will be repeated three times and the average value will be calculated.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
Range of Motion
Mouth opening, protrusion and right and left lateral deviation will be measured starting from 0 using a 15 cm ruler. Repeated measuring reduces the standard error of measurement, hence repeated measurements will be also included in our study (three times) with the largest recorded range taken.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
First Test for Sacroiliac Joint Disfunction: Distraction Test
The patient lies in a supine position. Direct posterolateral pressure is applied to the bilateral anterior superior iliac spines, thus stressing the anterior sacroiliac ligament. Pathology in the Sacroiliac (SI) joint is considered if pain occurs in the hip.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
Second Test for Sacroiliac Joint Disfunction: Compression Test
The patient lies on his side with the affected side on top, with the hip at 45° flexion and the knees at 90° flexion. The physician stands behind the patient and applies pressure to the pelvis over the iliac crest directly toward the contralateral iliac crest. This test can be applied in a supine or prone position. Pathology in the SI joint is considered if pain occurs in the hip.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
Third Test for Sacroiliac Joint Disfunction: Thigh Thrust Test
The patient lies in a supine position. The hip is brought to 90º flexion. Pressure is applied directly toward the examination table. Pathology in the SI joint is considered if pain occurs in the hip. Pain provocation is established with hip flexion and adduction.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
Fourth Test for Sacroiliac Joint Disfunction: Gaenslen Test
The patient lies in a supine position close to the edge of the bed. The patient draws his leg toward the abdomen so as to place the knee and hip in flexion. The outside leg (closest to the practitioner) is allowed to hang down from the examination table, while the SI joint is contracted by placing pressure on the inside (furthest from the practitioner) iliac crest and outside leg. Pain indicates pathology of the SI joint on the tested side.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
Fifth Test for Sacroiliac Joint Disfunction: Sacral Thrust Test
The patient lies in a prone position. The practitioner places one hand on the apex of the sacrum while applying direct pressure with the other hand. Pathology in the SI joint is considered if pain occurs in the hip.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
Sixth Test for Sacroiliac Joint Disfunction: Faber (Patrick) Test
The patient lies in a supine position, while the practitioner stands beside the patient and bends the patient's knee, bringing the heel to the opposite knee. With the other hand, the practitioner ensures that the contralateral anterior superior iliac spine remains in a neutral position. The physician applies mild pressure to the bent knee. Pressure is assumed to be applied to the bilateral SI ligaments and hip joints. Pathology in the SI joint is considered if pain occurs in the hip. Pain provocation occurs with flexion, adduction and external rotation of the hip.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
Secondary outcomes (1)
Oswestry Disability Index (ODI) for Functional Low Back Pain
Oswestry Disability Index (ODI) will be used to evaluate low back pain. ODI consists of 10 items on the degree of severity to which low back trouble has affected the ability to manage in everyday life. The 10 sections cover the pain and the daily function (including pain intensity, personal hygiene, lifting, walking, sitting, standing, sleeping, sexual activity, social activity, and traveling). Each item is rated on a 6-point scale (0-5); the higher score means the higher level of disability related to low back pain.
Measured: Change between baseline (immediately before intervention) and 1 week post intervention. The intervention is one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Sep 2023
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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 Marmara UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- There are one study group. A single session of orofacial manual therapy will be applied to all participants.
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tugba Kuru Colak, Asst. Prof, Study director, Marmara University Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035341
- Sponsor's protocol ID
- 09.2023.675
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study.
Publications
Anastassaki Kohler A, Hugoson A, Magnusson T. Prevalence of symptoms indicative of temporomandibular disorders in adults: cross-sectional epidemiological investigations covering two decades. Acta Odontol Scand. 2012 May;70(3):213-23. doi: 10.3109/00016357.2011.634832. Epub 2011 Nov 30.
PubMed 22126531Kiapour A, Joukar A, Elgafy H, Erbulut DU, Agarwal AK, Goel VK. Biomechanics of the Sacroiliac Joint: Anatomy, Function, Biomechanics, Sexual Dimorphism, and Causes of Pain. Int J Spine Surg. 2020 Feb 10;14(Suppl 1):3-13. doi: 10.14444/6077. eCollection 2020 Feb.
PubMed 32123652Gregory TM. Temporomandibular disorder associated with sacroiliac sprain. J Manipulative Physiol Ther. 1993 May;16(4):256-65.
PubMed 8340721Chinappi AS Jr, Getzoff H. Chiropractic/dental cotreatment of lumbosacral pain with temporomandibular joint involvement. J Manipulative Physiol Ther. 1996 Nov-Dec;19(9):607-12.
PubMed 8976480Fink M, Wahling K, Stiesch-Scholz M, Tschernitschek H. The functional relationship between the craniomandibular system, cervical spine, and the sacroiliac joint: a preliminary investigation. Cranio. 2003 Jul;21(3):202-8. doi: 10.1080/08869634.2003.11746252.
PubMed 12889677Tuncer AB, Ergun N, Tuncer AH, Karahan S. Effectiveness of manual therapy and home physical therapy in patients with temporomandibular disorders: A randomized controlled trial. J Bodyw Mov Ther. 2013 Jul;17(3):302-8. doi: 10.1016/j.jbmt.2012.10.006. Epub 2012 Nov 16.
PubMed 23768273Kalamir A, Pollard H, Vitiello A, Bonello R. Intra-oral myofascial therapy for chronic myogenous temporomandibular disorders: a randomized, controlled pilot study. J Man Manip Ther. 2010 Sep;18(3):139-46. doi: 10.1179/106698110X12640740712374.
PubMed 21886424von Piekartz H, Ludtke K. Effect of treatment of temporomandibular disorders (TMD) in patients with cervicogenic headache: a single-blind, randomized controlled study. Cranio. 2011 Jan;29(1):43-56. doi: 10.1179/crn.2011.008.
PubMed 21370769Walker N, Bohannon RW, Cameron D. Discriminant validity of temporomandibular joint range of motion measurements obtained with a ruler. J Orthop Sports Phys Ther. 2000 Aug;30(8):484-92. doi: 10.2519/jospt.2000.30.8.484.
PubMed 10949505Telli H, Telli S, Topal M. The Validity and Reliability of Provocation Tests in the Diagnosis of Sacroiliac Joint Dysfunction. Pain Physician. 2018 Jul;21(4):E367-E376.
PubMed 30045603Robinson HS, Brox JI, Robinson R, Bjelland E, Solem S, Telje T. The reliability of selected motion- and pain provocation tests for the sacroiliac joint. Man Ther. 2007 Feb;12(1):72-9. doi: 10.1016/j.math.2005.09.004. Epub 2006 Jul 12.
PubMed 16843031Laslett M, Young SB, Aprill CN, McDonald B. Diagnosing painful sacroiliac joints: A validity study of a McKenzie evaluation and sacroiliac provocation tests. Aust J Physiother. 2003;49(2):89-97. doi: 10.1016/s0004-9514(14)60125-2.
PubMed 12775204Martin RL, Sekiya JK. The interrater reliability of 4 clinical tests used to assess individuals with musculoskeletal hip pain. J Orthop Sports Phys Ther. 2008 Feb;38(2):71-7. doi: 10.2519/jospt.2008.2677. Epub 2007 Sep 21.
PubMed 18560194Cattley P, Winyard J, Trevaskis J, Eaton S. Validity and reliability of clinical tests for the sacroiliac joint. A review of literature. Australas Chiropr Osteopathy. 2002 Nov;10(2):73-80.
PubMed 17987177Laslett M, Aprill CN, McDonald B, Young SB. Diagnosis of sacroiliac joint pain: validity of individual provocation tests and composites of tests. Man Ther. 2005 Aug;10(3):207-18. doi: 10.1016/j.math.2005.01.003.
PubMed 16038856
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction?
- ClinicalTrials.gov ID
- NCT06035341
- Acronym / sponsor ID
- 09.2023.675
- Keywords
- Temporomandibular Joint Disorders, Temporomandibular Joint, Sacroiliac Joint, Orofacial Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 13 Sep 2023 (actual)
- 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 this study is to evaluate the relationship between Temporomandibular Disorders (TMD) and Sacroiliac Joint Disfunction (SIJD) and to determine the immediate effect of single-session orofacial manual therapy on SIJD. Patients will be treated for 1 session. The evaluation was planned to be done twice, at the beginning and end of the session.
Detailed description
The aim of this study is to evaluate the relationship between TMD and SIJD and to determine the immediate effect of single-session orofacial manual therapy on SIJD. Patients diagnosed with both TMD and SIJD will be participants of the study. Patients will be treated for 1 session. Immediately after the treatment, participants will be asked to walk for 5 minutes, after which a second assessment will be done. The evaluation was planned to be done twice, at the beginning and end of the session. Pressure pain threshold, joint range of motion, functionality, and sacroiliac joint disfunction will be evaluated by using digital algometer, ruler, "Oswestry Disability Index (ODI)" and specific tests respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There are one study group. A single session of orofacial manual therapy will be applied to all participants.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Orofacial Manual TherapyParticipants in this group will be received orofacial manual therapy as treatment. The number of participants is planned to be 23. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Volunteered to participate,
- Aged between 18-60 years old,
- Having the diagnosis of Temporomandibular Disorders (TMB) and sacroiliac joint disfunction (SIJD),
Key exclusion criteria (9 listed)
- Having a malignant condition, trauma and surgery of the cranial and cervical region,
- Not being cooperative,
- Regular use of analgesic and anti-inflammatory drugs,
- Having dentofacial anomalies,
- Having active inflammatory arthritis,
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 |
|---|---|---|
| Orofacial Manual TherapyAs orofacial manual therapy, soft tissue (intraoral and extraoral trigger point therapy and myofascial release of painful muscles) and joint mobilization (caudal and ventro-caudal traction, ventral and mediolateral translation), muscle energy technique, fascia mandibularis release, occipital release and ligamentous treatment was planned. | Other | Treatment Group |
Primary outcome
Pain Threshold: Digital algometer
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
The algometer is a reliable instrument for measuring the sensitivity of the masticatory muscles and 1 cm below the Posterior Superior Iliac Spine (PSIS). The measurement will be made at 10 points. A force (Newton in force) of 1 kg (weight in kilogram) per square centimeter (surface area in centimeter square) is applied to the patient for 3 seconds, and this is continued until the patient feels pain (weight and surface area will be combined to report Newton in kg/ cm2). This process will be repeated three times and the average value will be calculated.
Range of Motion
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
Mouth opening, protrusion and right and left lateral deviation will be measured starting from 0 using a 15 cm ruler. Repeated measuring reduces the standard error of measurement, hence repeated measurements will be also included in our study (three times) with the largest recorded range taken.
First Test for Sacroiliac Joint Disfunction: Distraction Test
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
The patient lies in a supine position. Direct posterolateral pressure is applied to the bilateral anterior superior iliac spines, thus stressing the anterior sacroiliac ligament. Pathology in the Sacroiliac (SI) joint is considered if pain occurs in the hip.
Second Test for Sacroiliac Joint Disfunction: Compression Test
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
The patient lies on his side with the affected side on top, with the hip at 45° flexion and the knees at 90° flexion. The physician stands behind the patient and applies pressure to the pelvis over the iliac crest directly toward the contralateral iliac crest. This test can be applied in a supine or prone position. Pathology in the SI joint is considered if pain occurs in the hip.
Third Test for Sacroiliac Joint Disfunction: Thigh Thrust Test
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
The patient lies in a supine position. The hip is brought to 90º flexion. Pressure is applied directly toward the examination table. Pathology in the SI joint is considered if pain occurs in the hip. Pain provocation is established with hip flexion and adduction.
Fourth Test for Sacroiliac Joint Disfunction: Gaenslen Test
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
The patient lies in a supine position close to the edge of the bed. The patient draws his leg toward the abdomen so as to place the knee and hip in flexion. The outside leg (closest to the practitioner) is allowed to hang down from the examination table, while the SI joint is contracted by placing pressure on the inside (furthest from the practitioner) iliac crest and outside leg. Pain indicates pathology of the SI joint on the tested side.
Fifth Test for Sacroiliac Joint Disfunction: Sacral Thrust Test
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
The patient lies in a prone position. The practitioner places one hand on the apex of the sacrum while applying direct pressure with the other hand. Pathology in the SI joint is considered if pain occurs in the hip.
Sixth Test for Sacroiliac Joint Disfunction: Faber (Patrick) Test
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
The patient lies in a supine position, while the practitioner stands beside the patient and bends the patient's knee, bringing the heel to the opposite knee. With the other hand, the practitioner ensures that the contralateral anterior superior iliac spine remains in a neutral position. The physician applies mild pressure to the bent knee. Pressure is assumed to be applied to the bilateral SI ligaments and hip joints. Pathology in the SI joint is considered if pain occurs in the hip. Pain provocation occurs with flexion, adduction and external rotation of the hip.
1 secondary outcome
Oswestry Disability Index (ODI) for Functional Low Back Pain
Time frame: Change between baseline (immediately before intervention) and 1 week post intervention. The intervention is one hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 22126531Anastassaki Kohler A, Hugoson A, Magnusson T. Prevalence of symptoms indicative of temporomandibular disorders in adults: cross-sectional epidemiological investigations covering two decades. Acta Odontol Scand. 2012 May;70(3):213-23. doi: 10.3109/00016357.2011.634832. Epub 2011 Nov 30.
- Background: PubMed 32123652Kiapour A, Joukar A, Elgafy H, Erbulut DU, Agarwal AK, Goel VK. Biomechanics of the Sacroiliac Joint: Anatomy, Function, Biomechanics, Sexual Dimorphism, and Causes of Pain. Int J Spine Surg. 2020 Feb 10;14(Suppl 1):3-13. doi: 10.14444/6077. eCollection 2020 Feb.
- Background: PubMed 8340721Gregory TM. Temporomandibular disorder associated with sacroiliac sprain. J Manipulative Physiol Ther. 1993 May;16(4):256-65.
- Background: PubMed 8976480Chinappi AS Jr, Getzoff H. Chiropractic/dental cotreatment of lumbosacral pain with temporomandibular joint involvement. J Manipulative Physiol Ther. 1996 Nov-Dec;19(9):607-12.
- Background: PubMed 12889677Fink M, Wahling K, Stiesch-Scholz M, Tschernitschek H. The functional relationship between the craniomandibular system, cervical spine, and the sacroiliac joint: a preliminary investigation. Cranio. 2003 Jul;21(3):202-8. doi: 10.1080/08869634.2003.11746252.
- Background: PubMed 23768273Tuncer AB, Ergun N, Tuncer AH, Karahan S. Effectiveness of manual therapy and home physical therapy in patients with temporomandibular disorders: A randomized controlled trial. J Bodyw Mov Ther. 2013 Jul;17(3):302-8. doi: 10.1016/j.jbmt.2012.10.006. Epub 2012 Nov 16.
- Background: PubMed 21886424Kalamir A, Pollard H, Vitiello A, Bonello R. Intra-oral myofascial therapy for chronic myogenous temporomandibular disorders: a randomized, controlled pilot study. J Man Manip Ther. 2010 Sep;18(3):139-46. doi: 10.1179/106698110X12640740712374.
- Background: PubMed 21370769von Piekartz H, Ludtke K. Effect of treatment of temporomandibular disorders (TMD) in patients with cervicogenic headache: a single-blind, randomized controlled study. Cranio. 2011 Jan;29(1):43-56. doi: 10.1179/crn.2011.008.
- Background: PubMed 10949505Walker N, Bohannon RW, Cameron D. Discriminant validity of temporomandibular joint range of motion measurements obtained with a ruler. J Orthop Sports Phys Ther. 2000 Aug;30(8):484-92. doi: 10.2519/jospt.2000.30.8.484.
- Background: PubMed 30045603Telli H, Telli S, Topal M. The Validity and Reliability of Provocation Tests in the Diagnosis of Sacroiliac Joint Dysfunction. Pain Physician. 2018 Jul;21(4):E367-E376.
- Background: PubMed 16843031Robinson HS, Brox JI, Robinson R, Bjelland E, Solem S, Telje T. The reliability of selected motion- and pain provocation tests for the sacroiliac joint. Man Ther. 2007 Feb;12(1):72-9. doi: 10.1016/j.math.2005.09.004. Epub 2006 Jul 12.
- Background: PubMed 12775204Laslett M, Young SB, Aprill CN, McDonald B. Diagnosing painful sacroiliac joints: A validity study of a McKenzie evaluation and sacroiliac provocation tests. Aust J Physiother. 2003;49(2):89-97. doi: 10.1016/s0004-9514(14)60125-2.
- Investigation of the Relationship Between Temporomandibular Disorder and Postural AnalysisLink provided by the sponsor.
- Manual Therapy for Temporomandibular Disorders: A Review of the Literature.Link provided by the sponsor.
- Pressure Pain Threshold and Pain Perception in Temporomandibular Disorder Patients: Is There Any Correlation?Link provided by the sponsor.
- Individual participant dataSharing planned: No. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study.
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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.
Tugba Kuru Colak, Asst. Prof study director
Marmara University Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orofacial Manual Therapy in people with Temporomandibular Joint Disorders and Temporomandibular Disorder, run by Marmara University at 1 site in Turkey (Türkiye).
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 3 inclusion and 9 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 13 Sep 2023. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sultan Igrek, MSc (+05372100654, sultanigrek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Threshold: Digital algometer (time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.). The study lists 8 primary outcomes in all. 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 NCT06035341, which also lists 18 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 13 Sep 2023.