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

Çukurova University

Status: Active, not recruiting

Conditions: Central Sensitization; Myofacial Pain

Treatments: Device: Stabilization splint; Other: Muscle exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06869161

CU-PDT-IC-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Control group

No Intervention group

Description:

Participants were trained on the protection program.

Stabilization splint group

Active Comparator group

Description:

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.

Treatment:

Device: Stabilization splint

Exercises Group

Active Comparator group

Description:

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

Treatment:

Other: Muscle exercises

Stabilization Splint and Exercises Group

Active Comparator group

Description:

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.

Treatment:

Device: Stabilization splint