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

This study is not yet open for participant recruitment.
Verified May 2017 by Alaa Ahmed Mohamed Ammar, Cairo University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03161210
First Posted: May 19, 2017
Last Update Posted: May 22, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alaa Ahmed Mohamed Ammar, Cairo University
  Purpose
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 Intervention
Myofascial Pain Syndrome Other: Dextrose Prolotherapy Other: Local Anaesthesia Other: Saline

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Alaa Ahmed Mohamed Ammar, Cairo University:

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)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Alaa Ahmed Mohamed Ammar, Principal Investigator, Internal resident in Oral and Maxillofacial Department, faculty of oral and dental medicine., Cairo University
ClinicalTrials.gov Identifier: NCT03161210     History of Changes
Other Study ID Numbers: 28712038800227
First Submitted: May 18, 2017
First Posted: May 19, 2017
Last Update Posted: May 22, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Myofascial Pain Syndromes
Fibromyalgia
Facial Pain
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents