Ultrasound Guided Versus Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint.

Study Overview
=================
Brief Summary
-----------------
Ultrasound Guided Versus Non-Guided Prolotherapy for Treatment of Internal Derangement of Temporomandibular joint. Rationale for conducting the research: The most critical cause for guided prolotherapy is to specify the accurate location of glenoid fossa and the disc space while prolotherapy procedure, and to adjust the needle insertion to according to articular eminence, mandibular condyle, and intra-articular space as anatomical variations. The vibration of ultrasound waves generates a heat so there is a thermal effective for prolotherapy effusion in the TMJ space.

Official Title
-----------------
Ultrasound Guided Versus Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint.

Conditions
-----------------
TMJ Disc Disorder, Ultrasound Therapy; Complications, TMJ, Prolotherapy, Internal Derangement, Clicking Tinnitus, Injection Site, Pain, Chronic, Anterior Disc Displacement, Myofascial Pain Syndrome, Masticatory Muscle

Intervention / Treatment
-----------------
* Procedure: Prolotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with TMD - internal derangement with symptomatic clicking pain, according to RDC (Research diagnostic criteria for TMJD) sheet . Muscles spasm causing TMDs. Patients who failed to improve on conservative measures or highly hyperactivity patients. Female and male patients age range from 20 to 60 years old. Exclusion Criteria: Patients who refused to be included in the research. Patients with a systemically diseases or inflammation whether local or generalized. Patients with bleeding disorders. Patients with unknown dextrose allergy.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Guided Prolotherapy forTreatment of Internal Derangement of TMJD.<br>Injection procedure in TMJ Space guided by ultrasound probe the injection materials will be composition of ( !0% Dextrose ) + (Saline ) + (2% Lidocaine, plain anesthesia ). The intervention procedure will done after TMJ MRI assessment for patients who have anterior disc displacement with reduction (DDWR) | Procedure: Prolotherapy<br>* Prolotherapy is an injection treatment used to relieve pain. And for Cellular Regeneration<br>|
| Active Comparator: Non-Guided Ultrasound ( Blind) Prolotherapy for Treatment of Internal Derangement of TMJD.<br>Injection procedure in TMJ Space by anatomical land mark (blindly), and we also call it ( conventional prolotherapy ) the injection materials will be composition of ( !0% Dextrose ) + (Saline ) + (2% Lidocaine, plain anesthesia ). The intervention procedure will done after TMJ MRI assessment for patients who have anterior disc displacement with reduction (DDWR) | Procedure: Prolotherapy<br>* Prolotherapy is an injection treatment used to relieve pain. And for Cellular Regeneration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale | psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients | Change from Baseline VAS at 4 weeks ( lower score means better outcome) | 
| visual analogue scale | psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients | VAS change at 2 months ( lower score means better outcome ) |