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Comparison of Treatment Alternatives for Myofascial Pain Causing Central Sensitization

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06869161
Acronym
Myofascialpain
Enrollment
80
Registered
2025-03-11
Start date
2025-05-12
Completion date
2026-05-25
Last updated
2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Sensitization, Myofacial Pain

Keywords

central sensitization, myofacial pain, stabilization splints, muscle thickness, muscle exercises

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.

Interventions

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.

OTHERMuscle exercises

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

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Muscle ThicknessBaseline, 2 weeks, 4 weeks, 8 weeks, 12 weeksBilateral 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.

Secondary

MeasureTime frameDescription
Graded chronic pain scaleBaseline, 4 weeks, 8 weeks, 12 weeksA 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026