The Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction

September 6, 2023 updated by: Marmara University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34275
        • Recruiting
        • Sultan İğrek
        • Contact:
          • Phone Number: 05372100654

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Change between baseline (immediately before intervention) and post intervention (immediately after intervention). The intervention is one hour.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Change between baseline (immediately before intervention) and 1 week post intervention. The intervention is one hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Study Director: Tugba Kuru Colak, Asst. Prof, Marmara University Institute of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 15, 2023

Study Completion (Estimated)

October 15, 2023

Study Registration Dates

First Submitted

August 25, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2023.675

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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