Clinical trial NCT06869161: Comparison of Treatment Alternatives for Myofascial Pain Causing Central Sensitization
Official title: Comparison of the Effects of Stabilization Splint and Muscle Exercises on Pain and Muscle Thickness in Patients With Central Sensitization Caused by Myofascial Pain: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myofacial Pain
Central Sensitization
Keywords: central sensitization
myofacial pain
stabilization splints
muscle thickness
muscle exercises
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Muscle Thickness
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Graded chronic pain scale
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Sarıçam
country: Turkey
facility: Çukurova Üniversitesi Diş Hekimliği Fakültesi Protetik Diş Tedavisi Anabilim Dalı
state: Balcalı Mahallesi
Study officials:
References: