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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03161210

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myofascial Pain Syndrome	Other: Dextrose Prolotherapy Other: Local Anaesthesia Other: Saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

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.

Anticipated Study Start Date :

Sep 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Patients' subjective pain experience [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

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.

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.

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Other Study ID Numbers: