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

NCT05138354 | Completed

• 1 other identifier: PTMD2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Limitations of daily function in temporomandibular disorder questionnaire

  Baseline and after 4 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Intervention group

EXPERIMENTAL

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; Other: Myofascial release; Other: Standard care

Interventions

Low Level laser therapy OTHER

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.

Intervention group

Myofascial release OTHER

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.

Intervention group

Standard care OTHER

1. 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. 2. Hot pack Participants will receive a warm water pack the TMJ and masticatory muscles for 10 minutes. 3. Exercise program: Active exercises for mandibular muscles will be used to correct the mouth opening 1. Lateral movements of the jaw (3 sets of 10 repetitions). 2. Jaw relaxation exercise (3 sets of 10 repetitions). 3. Chin tuck (10 repetitions, holding 10s each). 4. Resisted opening of the mouth (3 sets of 10 repetitions). 5. Resisted closing of the mouth (3 sets of 10 repetitions). 6. Stretching exercise for mandibular muscles.

Control group; Intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 University Hospital

Al Ḩayy Ath Thāmin, Giza Governorate, 12511, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Low-Level Light Therapy; Myofascial Release Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Radwa M Yehia, Ph.D

  Faculty of Physical Therapy, October 6 University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: February 18, 2021
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 Months after study publication
• Access Criteria: Email: mohamed.magdy.pt@o6u.edu.eg

Locations

EG (1)