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NCT Number: NCT06869161

Comparison of Treatment Alternatives for Myofascial Pain Causing Central Sensitization

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Myofacial Pain Central Sensitization Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Çukurova Üniversitesi Diş Hekimliği Fakültesi Protetik Diş Tedavisi Anabilim Dalı

Sarıçam, Balcalı Mahallesi, 01250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

stabilization splint

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.

Other names: exercises

Muscle exercises

Other

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

Primary outcomes

  1. Muscle Thickness

    Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks

    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.

Secondary outcomes

  1. Graded chronic pain scale

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study 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

Acronym: Myofascialpain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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