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.


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Verified May 2017 by Cairo University

Sponsor:

Information provided by (Responsible Party):

Alaa Ahmed Mohamed Ammar, Cairo University

ClinicalTrials.gov Identifier:

NCT03161210

First received: May 18, 2017

Last updated: May 18, 2017

Last verified: May 2017

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.

Myofascial Pain Syndrome Other: Dextrose Prolotherapy
Other: Local Anaethesia
Other: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Primary Outcome Measures:

  • 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.

Estimated Enrollment: 80
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Experimental: Dextrose Prolotherapy Other: Dextrose Prolotherapy

Dextrose is a solution, mixture of dextrose and water.

Active Comparator: Local Anaethetic Other: Local Anaethesia

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

Placebo Comparator: Saline Other: Saline

Saline is a control group

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

Responsible Party: Alaa Ahmed Mohamed Ammar, Internal resident in Oral and Maxillofacial Department, faculty of oral and dental medicine, cairo university, Cairo University
ClinicalTrials.gov Identifier: NCT03161210     History of Changes
Other Study ID Numbers: 28712038800227
Study First Received: May 18, 2017
Last Updated: May 18, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Facial Pain
Myofascial Pain Syndromes
Fibromyalgia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2017