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

Myofascial Pain Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03161210
• Other study ID #: 28712038800227
• Status: Not yet recruiting
• Phase: N/A
• First received: May 18, 2017
• Last updated: May 19, 2017
• Start date: September 2017
• Est. completion date: April 2018

Study information

• Verified date: May 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Facial Pain
• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes

Intervention

Other:
• Dextrose Prolotherapy
Dextrose is a solution, mixture of dextrose and water.
• Local Anaesthesia
A local anaesthetic is a medication that causes reversible absence of pain sensation
• Saline
Saline is a control group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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