Standard Care With LLLT & Myofascial Release Versus Standard Care Alone in Pregnant Women With Temporomandibular Disorder

Standard Care Combined With Low-Level Laser Therapy and Myofascial Release Versus Standard Care Alone in Pregnant Women With Temporomandibular Disorder: A Randomized Controlled Trial

This study will investigate a novel approach to treat pregnant women with tempromandibular disorder using a combined method of low level laser therapy, myofascial release and standard care versus standard care alone. It's hopeful that the results of this study can fill the gap of knowledge surrounding the conservative treatment options for TMD in order to help patients restore their oral function properly and promote new ways of addressing TMD.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Disorder
• Intervention / Treatment: Other: Standard care; Other: Low Level laser therapy; Other: Myofascial release

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 12511
      • October 6 university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant women diagnosed with myofascial TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders

Exclusion Criteria:

• facial neuro-musculoskeletal pathologies (i.e., facial trauma and/or fractures, and bell's palsy)
• acute infections or systemic disorders
• osteoporosis
• cervical spine or upper limb dysfunction
• steroid infiltration4
• any recent dental treatment taken or surgery over TMJ
• hypermobile joint
• neurological impairments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Patients received a 4-week treatment program (12 treatment sessions, three times a week). Patients received the conservative treatment protocol comprised of ultrasound, hot pack application, and exercises.	Other: Standard care; Ultrasound Participants will receive an application of pulsed ultrasound at a frequency of 3 MHz and an intensity of 0.5 W/cm² with a 1:1 duty cycle over TMJ for six minutes.; Hot pack Participants will receive a warm water pack the TMJ and masticatory muscles for 10 minutes.; Exercise program: Active exercises for mandibular muscles will be used to correct the mouth opening; Lateral movements of the jaw (3 sets of 10 repetitions).; Jaw relaxation exercise (3 sets of 10 repetitions).; Chin tuck (10 repetitions, holding 10s each).; Resisted opening of the mouth (3 sets of 10 repetitions).; Resisted closing of the mouth (3 sets of 10 repetitions).; Stretching exercise for mandibular muscles.
Experimental: Intervention group; Patients received a 4-week treatment program (12 treatment sessions, three times a week). Patients received LLLT and myofascial release combined with the control intervention. the conservative treatment protocol comprised of ultrasound, hot pack application, and exercises	Other: Standard care; Ultrasound Participants will receive an application of pulsed ultrasound at a frequency of 3 MHz and an intensity of 0.5 W/cm² with a 1:1 duty cycle over TMJ for six minutes.; Hot pack Participants will receive a warm water pack the TMJ and masticatory muscles for 10 minutes.; Exercise program: Active exercises for mandibular muscles will be used to correct the mouth opening; Lateral movements of the jaw (3 sets of 10 repetitions).; Jaw relaxation exercise (3 sets of 10 repetitions).; Chin tuck (10 repetitions, holding 10s each).; Resisted opening of the mouth (3 sets of 10 repetitions).; Resisted closing of the mouth (3 sets of 10 repetitions).; Stretching exercise for mandibular muscles.; Other: Low Level laser therapy; MLS® device (ASA Srl, Vicenza, Italy) IR laser with two synchronized sources (laser diodes) and a wavelength of 808 nm to deliver the intervention. The laser probe will be held vertically in contact with the skin to deliver the irradiation at three mandibular condyle points (front, behind and over) and one point at the external acoustic meatus. The irradiation will be applied with a laser bean of 3.14 cm² diameter for 14 seconds at each place using a pulse rate of 1500 Hz, pulse duration of 100ns, and energy density: 16 J/cm².; Other: Myofascial release; Patients will be positioned in supine in a treatment table. The therapist seated beside the patient at the side of affected temporomandibular joint to apply gross release technique for masseter, pterygoid and temporalis muscles. At each point, the therapist applied the technique for 90 seconds and repeated 5 times during the session (5 seconds of rest between each repetition).(15) The therapist worn gloves to deliver the intraoral myofascial release. In case the patient reported any latex allergies, the gloves were replaced by a latex free model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in visual analogue scale	Visual analog scale (VAS), a grading scale range from 0 to 100 mm. 0 mm represented no pain or discomfort at all and 100 mm represented the greatest amount of pain or discomfort imaginable. Participant drew a line that intersects the grading scale to show the amount of pain or discomfort that he or she experienced at that moment. The assessor then used a ruler to measure the length from 0 mm to the intersecting line and recorded the value.	Baseline and after 4 weeks
Changes in pain pressure threshold (PPT)	Comparing pain pressure threshold differences on both sides over TMJ, masseter and anterior temporalis.	Baseline and after 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limitations of daily function in temporomandibular disorder questionnaire	The limitations in daily functions in the temporomandibular disorder questionnaire (LDF-TMDQ) assess participants' functionality by asking them to report how much the jaw problem prevents or limits their performance in a list of 10 daily activities	Baseline and after 4 weeks

Collaborators and Investigators

• Sponsor: October 6 University
• Investigators: Study Director: Radwa M Yehia, Ph.D, Faculty of Physical Therapy, October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Actual): October 26, 2021
• Study Completion (Actual): October 26, 2021

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: PTMD2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all of the individual participant data collected during the trial and after deidentification
• IPD Sharing Time Frame: 6 Months after study publication
• IPD Sharing Access Criteria: Email: mohamed.magdy.pt@o6u.edu.eg
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No