Comparison of Treatment Alternatives for Myofascial Pain Causing Central Sensitization

NCT06869161 | Active Not Recruiting

• 1 other identifier: CU-PDT-IC-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofacial Pain; Central Sensitization

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Graded chronic pain scale

  Baseline, 4 weeks, 8 weeks, 12 weeks

Study Arms (4)

Control group

NO INTERVENTION

Participants were trained on the protection program.

Stabilization splint group

ACTIVE COMPARATOR

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

Exercises Group

ACTIVE COMPARATOR

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

Other: Muscle exercises

Stabilization Splint and Exercises Group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: exercises

Stabilization Splint and Exercises Group; Stabilization splint group

Muscle exercises OTHER

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

Exercises Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Examination of bilateral masseter and temporal muscles for the presence of trigger points
• Score above 40 on the CSI scale

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Çukurova Üniversitesi Diş Hekimliği Fakültesi Protetik Diş Tedavisi Anabilim Dalı

Sarıçam, Balcalı Mahallesi, 01250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Facial Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arş. Gör. Dt.

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: May 12, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 25, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)