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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03161210
Recruitment Status : Unknown
Verified May 2017 by Alaa Ahmed Mohamed Ammar, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : May 19, 2017
Last Update Posted : May 22, 2017
Information provided by (Responsible Party):
Alaa Ahmed Mohamed Ammar, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myofascial Pain Syndrome Other: Dextrose Prolotherapy Other: Local Anaesthesia Other: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Pain Regression in Patients With Myofascial Facial Pain Treated by Dextrose Prolotherapy Versus Local Anesthetic Injections: A Prospective Double-blind Randomized Placebo-controlled Clinical Trial.
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Dextrose Prolotherapy Other: Dextrose Prolotherapy
Dextrose is a solution, mixture of dextrose and water.

Active Comparator: Local Anaesthetic Other: Local Anaesthesia
A local anaesthetic is a medication that causes reversible absence of pain sensation

Placebo Comparator: Saline Other: Saline
Saline is a control group

Primary Outcome Measures :
  1. Patients' subjective pain experience [ Time Frame: one year ]
    Pressure pain threshold (PPT): An algometer will be used to assess PPT. The algometer consists of a 1 cm2 rubber tipped plunger mounted on a force transducer. The pressure will be applied over the examined trigger point. The participants will be instructed to point when the sensation changed from pressure to pain. The mean of three trials will be calculated and used for analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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Responsible Party: Alaa Ahmed Mohamed Ammar, Principal Investigator, Internal resident in Oral and Maxillofacial Department, faculty of oral and dental medicine., Cairo University Identifier: NCT03161210     History of Changes
Other Study ID Numbers: 28712038800227
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Facial Pain
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents