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

Sponsor

October 6 University (Other)

Overall Status

Completed

CT.gov ID

NCT05138354

Collaborator

(none)

Enrollment

Location

Arms

8.2

Actual Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Disorder	Other: Low Level laser therapy Other: Myofascial release Other: Standard care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 18, 2021

Actual Primary Completion Date :

Oct 26, 2021

Actual Study Completion Date :

Oct 26, 2021

Arms and Interventions

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: 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. 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.

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: 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.

Other: Standard care

Outcome Measures

Primary Outcome Measures

Changes in visual analogue scale [Baseline and after 4 weeks]
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.
Changes in pain pressure threshold (PPT) [Baseline and after 4 weeks]
Comparing pain pressure threshold differences on both sides over TMJ, masseter and anterior temporalis.

Secondary Outcome Measures

Limitations of daily function in temporomandibular disorder questionnaire [Baseline and after 4 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	October 6 University Hospital	Al Ḩayy Ath Thāmin	Giza	Egypt	12511

Sponsors and Collaborators

October 6 University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Magdy Ali Hassan ElMeligie, Principal investigator, October 6 University

ClinicalTrials.gov Identifier:

NCT05138354

Other Study ID Numbers:

PTMD2021

First Posted:

Dec 1, 2021

Last Update Posted:

Dec 1, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Temporomandibular Joint Disorders

Temporomandibular Joint Dysfunction Syndrome

Study Results

No Results Posted as of Dec 1, 2021