Evaluation of Pain Regression in Patients With Myofascial Facial Pain Using Dextrose, Local Anaesthesia and Saline.

NCT ID: NCT03161210

Last Updated: 2017-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-30

Study Completion Date

2018-04-30

Brief Summary

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The aim of this study is to compare the treatment effects of dextrose prolotherapy, saline, and mepivacaine for deactivating myofascial trigger points within the jaw muscles.

Detailed Description

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Conditions

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Myofascial Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dextrose Prolotherapy

Group Type EXPERIMENTAL

Dextrose Prolotherapy

Intervention Type OTHER

Dextrose is a solution, mixture of dextrose and water.

Local Anaesthetic

Group Type ACTIVE_COMPARATOR

Local Anaesthesia

Intervention Type OTHER

A local anaesthetic is a medication that causes reversible absence of pain sensation

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Saline is a control group

Interventions

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Dextrose Prolotherapy

Dextrose is a solution, mixture of dextrose and water.

Intervention Type OTHER

Local Anaesthesia

A local anaesthetic is a medication that causes reversible absence of pain sensation

Intervention Type OTHER

Saline

Saline is a control group

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- 1. Presence of active myofacial pains in jaw muscles, previously identified by manual palpation.

2\. Age ≥ 18 years. 3. Willingness to follow instructions

Exclusion Criteria

* 1\. Therapeutic intervention for myofascial pain within the past month before the study, such as using of medications for pain control or wearing of occlusal splint.

2\. Clinical conditions such as pregnancy. 3. Medical problems that may interfere with the procedures such as bleeding disorders, trigeminal neuralgia.

4\. Recent facial or neck trauma; medication or adjunctive treatment (eg, physiotherapy) that could not be stopped during the study; or allergy to local anesthetic solutions.

5\. Cognitive impairment or exhibited inadequate cooperation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Ahmed Mohamed Ammar

Principal Investigator, Internal resident in Oral and Maxillofacial Department, faculty of oral and dental medicine.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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28712038800227

Identifier Type: -

Identifier Source: org_study_id

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