Comparison of Treatment Alternatives for Myofascial Pain Causing Central Sensitization (Myofascialpain)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Central Sensitization; Myofacial Pain
• Intervention / Treatment: Device: Stabilization splint; Other: Muscle exercises

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Balcalı Mahallesi
    • Sarıçam, Balcalı Mahallesi, Turkey, 01250
      • Çukurova Üniversitesi Diş Hekimliği Fakültesi Protetik Diş Tedavisi Anabilim Dalı

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Participants were trained on the protection program.
Active Comparator: 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.	Device: 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.; Other Names: exercises
Active Comparator: Exercises Group; Participants will be given home-based exercise programs prepared by physical therapists.	Other: Muscle exercises; Muscle exercises prepared by physical therapists will be planned to relieve trigger points in the masticatory muscles.
Active Comparator: 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.	Device: 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.; Other Names: exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Thickness	Bilateral masseter and temporal muscle thicknesses of the participants will be measured with an ultrasound device (Clarius L7, Vancouver, Canada) , muscle thickness differences will be evaluated and the time period in which the effectiveness of the treatments will be observed will be determined.	Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graded chronic pain scale	A questionnaire (Graded Chronic Pain Scale -1 to 10 grades scale index-, will be used to assess changes in the amount and frequency of pain and its impact on daily life.	Baseline, 4 weeks, 8 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Cukurova University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 25, 2026

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: myofacial pain; central sensitization; muscle thickness; stabilization splints; muscle exercises
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Facial Pain
• Other Study ID Numbers: CU-PDT-IC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No