Ultrasound-Guided Vs Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint. a Randomized Clinical Trial

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.

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Key information

Conditions

TMJ Disc Disorder Anterior Disc Displacement Chronic Pain Clicking Tinnitus Ear Diseases Hearing Disorders Injection Site Internal Derangement Masticatory Muscle Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndrome Myofascial Pain Syndromes Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Prolotherapy Sensation Disorders Signs and Symptoms TMJ Tinnitus Ultrasound Therapy; Complications

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CairoU

Cairo, Al Manial, Old Cairo, 11553, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prolotherapy

Procedure

Prolotherapy is an injection treatment used to relieve pain. And for Cellular Regeneration

Primary outcomes

visual analogue scale

Time frame: Change from Baseline VAS at 4 weeks ( lower score means better outcome)

psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients
visual analogue scale

Time frame: VAS change at 2 months ( lower score means better outcome )

psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Nov 28, 2022
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed