Evaluation of Pain Regression in Patients With Myofascial Facial Pain Using Dextrose, Local Anaesthesia and Saline.
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2017
CompletedFirst Posted
Study publicly available on registry
May 19, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedMay 22, 2017
May 1, 2017
3 months
May 18, 2017
May 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Patients' subjective pain experience
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.
one year
Study Arms (3)
Dextrose Prolotherapy
EXPERIMENTALLocal Anaesthetic
ACTIVE COMPARATORSaline
PLACEBO COMPARATORInterventions
Dextrose is a solution, mixture of dextrose and water.
A local anaesthetic is a medication that causes reversible absence of pain sensation
Eligibility Criteria
You may qualify if:
- \- 1. Presence of active myofacial pains in jaw muscles, previously identified by manual palpation.
- \. Age ≥ 18 years. 3. Willingness to follow instructions
You may not qualify if:
- \. 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.
- \. Clinical conditions such as pregnancy. 3. Medical problems that may interfere with the procedures such as bleeding disorders, trigeminal neuralgia.
- \. 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.
- \. Cognitive impairment or exhibited inadequate cooperation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Internal resident in Oral and Maxillofacial Department, faculty of oral and dental medicine.
Study Record Dates
First Submitted
May 18, 2017
First Posted
May 19, 2017
Study Start
September 1, 2017
Primary Completion
December 1, 2017
Study Completion
April 1, 2018
Last Updated
May 22, 2017
Record last verified: 2017-05