Comparison of Treatment Alternatives for Myofascial Pain Causing Central Sensitization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2026-05-25

Brief Summary

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Myofascial pain is a regional muscle pain condition characterized by hard local areas and tender bands, known for the presence of trigger points in muscle tissue. The treatment is to eliminate the etiologic factor. Regular exercise is recommended to relieve the trigger points. Occlusal splints, considered the gold standard in the treatment of temporomandibular joint disorders, are used to manage and control symptoms. In this study, patients between the ages of 18-45 years who applied to Çukurova University Faculty of Dentistry, Department of Prosthodontics with the complaint of myofascial pain and scored above 40 on the central sensitization scale will be taken as a sample.

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Detailed Description

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Patients scoring 40 and above on the CSI scale will be evaluated according to the Diagnostic Criteria - Diagnostic Criteria for Temporomandibular Disorders (DC-TMD) and four groups will be formed including the control group diagnosed with myofascial pain. Bilateral masseter and temporal muscle thicknesses of all participants will be measured and recorded with a Clarius L7 ( Vancouver, Canada) ultrasound device. The control group will be trained and asked to comply with the training until the study is completed. The participants in the first experimental group will use occlusal splints that are digitally designed by transferring the impressions taken with intraoral scanner (TRIOS5, 3Shape TRIOS A/S, Copenhagen, Denmark) to the exocad design program and printed on three-dimensional printers. Participants in the second experimental group will be given home-based exercise programs prepared by physical therapists. Participants in the third experimental group will use occlusal splints digitally designed by transferring the impressions taken with intraoral scans (TRIOS5, 3Shape TRIOS A/S, Copenhagen, Denmark) to the exocad design program and printed on three-dimensional printers and will be given home-based exercise programs prepared by physical therapists.

Muscle thickness measurements will be repeated at week 2, week 4, week 8 of the treatments and pain report forms will be filled out. As of week 8, treatments will be terminated and patients will be called to the clinic for control visits at week 12 and muscle thickness measurements will be repeated and pain report forms will be filled.

Conditions

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Myofacial Pain Central Sensitization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Bilateral masseter and temporal muscle thicknesses of all participants will be measured and recorded with a Clarius L7 ultrasound device. Muscle thickness measurements will be repeated at week 2, week 4, week 8 of the treatments and pain report forms will be filled out. As of week 8, treatments will be terminated and patients will be called to the clinic for control visits at week 12 and muscle thickness measurements will be repeated and pain report forms will be filled.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control group

Participants were trained on the protection program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Stabilization splint group

The participants will use occlusal splints that are digitally designed by transferring the measurements taken with intraoral scans (TRIOS5, 3Shape TRIOS A/S, Copenhagen, Denmark) to the exocad design program and produced by three-dimensional printers.

Group Type ACTIVE_COMPARATOR

Stabilization splint

Intervention Type DEVICE

Measurements will be taken from the patients with intraoral scans, transferred to the design program and a stabilization splint will be digitally designed. The designed splint will be produced from 3D printers.

Exercises Group

Participants will be given home-based exercise programs prepared by physical therapists.

Group Type ACTIVE_COMPARATOR

Muscle exercises

Intervention Type OTHER

Muscle exercises prepared by physical therapists will be planned to relieve trigger points in the masticatory muscles.

Stabilization Splint and Exercises Group

Participants will use occlusal splints, which are digitally designed by transferring the measurements taken with intraoral scans (TRIOS5, 3Shape TRIOS A/S, Copenhagen, Denmark) to the exocad design program and produced from 3D printers, and home exercise programs prepared by physical therapists will be given.

Group Type ACTIVE_COMPARATOR

Stabilization splint

Intervention Type DEVICE

Measurements will be taken from the patients with intraoral scans, transferred to the design program and a stabilization splint will be digitally designed. The designed splint will be produced from 3D printers.

Interventions

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Stabilization splint

Measurements will be taken from the patients with intraoral scans, transferred to the design program and a stabilization splint will be digitally designed. The designed splint will be produced from 3D printers.

Intervention Type DEVICE

Muscle exercises

Muscle exercises prepared by physical therapists will be planned to relieve trigger points in the masticatory muscles.

Intervention Type OTHER

Other Intervention Names

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exercises

Eligibility Criteria

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Inclusion Criteria

* Examination of bilateral masseter and temporal muscles for the presence of trigger points
* Score above 40 on the CSI scale

Exclusion Criteria

* Noise during jaw movements (click, crepitation)
* Presence of systemic diseases involving joints (rheumatoid arthritis)
* Having received treatment for joint discomfort in the last six months (botox, splinting, exercise, counseling)
* Use of drugs affecting the central system (gabapentin, pregabalin, tricyclic antidepressants)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No