Myofacial PainMyofascialpainNCT06869161
Comparison of Treatment Alternatives for Myofascial Pain Causing Central Sensitization
A study testing Stabilization splint and Muscle exercises in people with Myofacial Pain and Central Sensitization, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Myofacial Pain, Central Sensitization
- What is being tested?
- Stabilization splint and Muscle exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2025to 25 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Examination of bilateral masseter and temporal muscles for the presence of trigger points
- Score above 40 on the CSI scale
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çukurova Üniversitesi Diş Hekimliği Fakültesi Protetik Diş Tedavisi Anabilim Dalı
Sarıçam, Balcalı Mahallesi, 01250
About this study
Official 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
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.
Read the 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.
- Conditions
- Myofacial Pain, Central Sensitization
- Being tested
- Stabilization splint, Muscle exercises
- Keywords
- central sensitization, myofacial pain, stabilization splints, muscle thickness, muscle exercises
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilization splintDevice
Also called exercises
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.
Muscle exercisesOther
Muscle exercises prepared by physical therapists will be planned to relieve trigger points in the masticatory muscles.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Stabilization splint |
| Exercises Group | Active comparator | Participants will be given home-based exercise programs prepared by physical therapists. Receives: 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. Receives: Device: Stabilization splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (1)
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start12 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion25 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofacial PainStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Çalışkan, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869161
- Sponsor's protocol ID
- CU-PDT-IC-01
- Acronym
- Myofascialpain
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 18 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06869161
- Acronym / sponsor ID
- Myofascialpain / CU-PDT-IC-01
- Conditions
- Myofacial Pain, Central Sensitization
- Keywords
- central sensitization, myofacial pain, stabilization splints, muscle thickness, muscle exercises
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 25 May 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants were trained on the protection program. |
| Stabilization splint group | Active comparator | Device: Stabilization splintThe 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. |
| Exercises Group | Active comparator | Other: Muscle exercisesParticipants will be given home-based exercise programs prepared by physical therapists. |
| Stabilization Splint and Exercises Group | Active comparator | Device: Stabilization splintParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Examination of bilateral masseter and temporal muscles for the presence of trigger points
- Score above 40 on the CSI scale
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stabilization splintAlso: exercisesMeasurements 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. | Device | Stabilization Splint and Exercises Group, Stabilization splint group |
| Muscle exercisesMuscle exercises prepared by physical therapists will be planned to relieve trigger points in the masticatory muscles. | Other | Exercises Group |
Primary outcome
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.
1 secondary outcome
Graded chronic pain scale
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilization splint and Muscle exercises in people with Myofacial Pain and Central Sensitization, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Thickness (time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.