NCT06327204

Brief Summary

Myofascial pain dysfunction syndrome is one of the common causes of non-odontogenic pain in the head and neck region. It accounts for 40-60% of the adult population. Different treatment modalities had been reported to release the trigger point within the muscles of mastication in order to reduce pain and allow recovery of the function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

March 15, 2024

Last Update Submit

March 20, 2024

Conditions

Myofascial Pain Syndrome

Keywords

Trigger Point Pain, Myofascial, Laser therapy

Outcome Measures

Primary Outcomes (1)

  • pain score

    a 10-point visual analogue score

    8 weeks

Secondary Outcomes (2)

  • maximum mouth opening

    8 weeks

  • quality of life questioner

    8 weeks

Study Arms (3)

Group I

ACTIVE COMPARATOR

patient received one session / week

Device: 940-nm diode laser / one session

group II

ACTIVE COMPARATOR

patient received two session / week

Device: 940-nm diode laser / two session

Group III

ACTIVE COMPARATOR

Patient received three session / week

Device: 940-nm diode laser/ three session

Interventions

940-nm diode laser / one sessionDEVICE

laser therapy using a 940-nm diode laser / one session per week

Group I
940-nm diode laser / two sessionDEVICE

laser therapy using a 940-nm diode laser / two session per week

group II
940-nm diode laser/ three sessionDEVICE

laser therapy using a 940-nm diode laser / three session per week

Group III

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • definite diagnosis of myofascial pain based on the DC/TMD criteria with a referral
  • presence of one or more trigger points in the masseter muscle
  • no history of any invasive procedures of the related masseter muscle.

You may not qualify if:

  • any painful conditions affecting the orofacial region
  • any systemic diseases that could masticatory function (e.g., rheumatoid arthritis and epilepsy)
  • pregnancy and lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, October 6 University

Cairo, 21523, Egypt

Location

Related Publications (3)

  • Ahrari F, Madani AS, Ghafouri ZS, Tuner J. The efficacy of low-level laser therapy for the treatment of myogenous temporomandibular joint disorder. Lasers Med Sci. 2014 Mar;29(2):551-7. doi: 10.1007/s10103-012-1253-6. Epub 2013 Jan 15.

    PMID: 23318917BACKGROUND

  • Maia ML, Bonjardim LR, Quintans Jde S, Ribeiro MA, Maia LG, Conti PC. Effect of low-level laser therapy on pain levels in patients with temporomandibular disorders: a systematic review. J Appl Oral Sci. 2012 Nov-Dec;20(6):594-602. doi: 10.1590/s1678-77572012000600002.

    PMID: 23329239BACKGROUND

  • Mahmoud NR, Shehab WI, AlAraby AA, Habaka YF. Efficacy of different low-level laser therapy sessions in the management of masseter muscle trigger points. BMC Oral Health. 2024 Sep 26;24(1):1125. doi: 10.1186/s12903-024-04780-y.

    PMID: 39327563DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • amany Ahmed, PhD

    faculty of dentistry, October 6 University, Egypt

    PRINCIPAL INVESTIGATOR

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
lecturer of Oral Medicine

Study Record Dates

First Submitted

March 15, 2024

First Posted

March 25, 2024

Study Start

March 1, 2023

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

March 25, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)