Verified May 2017 by Cairo University
Information provided by (Responsible Party):
Alaa Ahmed Mohamed Ammar, Cairo University
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
|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.|
- 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.
|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|
– 1. Presence of active myofacial pains in jaw muscles, previously identified by manual palpation.
2. Age ≥ 18 years. 3. Willingness to follow instructions
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.
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:
Myofascial Pain Syndromes
Nervous System Diseases
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
ClinicalTrials.gov processed this record on May 19, 2017