NCT06035341

Brief 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. The evaluation was planned to be done twice, at the beginning and end of the session.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

September 13, 2023

Status Verified

August 1, 2023

Enrollment Period

14 days

First QC Date

August 25, 2023

Last Update Submit

September 6, 2023

Conditions

Keywords

Temporomandibular Joint DisordersTemporomandibular JointSacroiliac JointOrofacial Pain

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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

    Change between baseline (immediately before intervention) and 1 week post intervention. The intervention is one hour.

Study Arms (1)

Treatment Group

EXPERIMENTAL

Participants in this group will be received orofacial manual therapy as treatment. The number of participants is planned to be 23.

Other: Orofacial Manual Therapy

Interventions

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.

Treatment Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteered to participate,
  • Aged between 18-60 years old,
  • Having the diagnosis of Temporomandibular Disorders (TMB) and sacroiliac joint disfunction (SIJD),

You may not qualify if:

  • 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),
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan İğrek

Istanbul, 34275, Turkey (Türkiye)

RECRUITING

Related Publications (18)

  • 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.

    PMID: 22126531BACKGROUND
  • Kiapour 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.

    PMID: 32123652BACKGROUND
  • Gregory TM. Temporomandibular disorder associated with sacroiliac sprain. J Manipulative Physiol Ther. 1993 May;16(4):256-65.

    PMID: 8340721BACKGROUND
  • Chinappi 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.

    PMID: 8976480BACKGROUND
  • Fink 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.

    PMID: 12889677BACKGROUND
  • Tuncer 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.

    PMID: 23768273BACKGROUND
  • Kalamir 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.

    PMID: 21886424BACKGROUND
  • von 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.

    PMID: 21370769BACKGROUND
  • Walker 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.

    PMID: 10949505BACKGROUND
  • Telli 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.

    PMID: 30045603BACKGROUND
  • Robinson 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.

    PMID: 16843031BACKGROUND
  • Laslett 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.

    PMID: 12775204BACKGROUND
  • Martin 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.

    PMID: 18560194BACKGROUND
  • Cattley 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.

    PMID: 17987177BACKGROUND
  • Laslett 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.

    PMID: 16038856BACKGROUND
  • Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.

    PMID: 6450426BACKGROUND
  • Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale. Phys Ther. 2001 Feb;81(2):776-88. doi: 10.1093/ptj/81.2.776.

    PMID: 11175676BACKGROUND
  • Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.

    PMID: 15129077BACKGROUND

Related Links

MeSH Terms

Conditions

Temporomandibular Joint DisordersFacial Pain

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tugba Kuru Colak, Asst. Prof

    Marmara University Institute of Health Sciences

    STUDY DIRECTOR

Central Study Contacts

Sultan Igrek, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: There are one study group. A single session of orofacial manual therapy will be applied to all participants.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2023

First Posted

September 13, 2023

Study Start

September 1, 2023

Primary Completion

September 15, 2023

Study Completion

October 15, 2023

Last Updated

September 13, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

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.

Locations