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The Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction

Primary Purpose

Temporomandibular Joint Disorders, Temporomandibular Disorder

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Orofacial Manual Therapy

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Temporomandibular Joint Disorders, Temporomandibular Joint, Sacroiliac Joint, Orofacial Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sultan İğrekRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT06035341

First Posted

August 25, 2023

Last Updated

September 6, 2023

Sponsor

Marmara University

1. Study Identification

Unique Protocol Identification Number

NCT06035341

Brief Title

The Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction

Official Title

Is There a Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction?

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2023 (Actual)

Primary Completion Date

September 15, 2023 (Anticipated)

Study Completion Date

October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Temporomandibular Joint Disorders, Temporomandibular Disorder

Keywords

Temporomandibular Joint Disorders, Temporomandibular Joint, Sacroiliac Joint, Orofacial Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

There are one study group. A single session of orofacial manual therapy will be applied to all participants.

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Orofacial Manual Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain Threshold: Digital algometer

Description

Time Frame