- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07708259
Effects of Cervical and Sacroiliac Mobilization Combined With Pilates on Bruxism
July 12, 2026 updated by: Elif Tuğçe Çil
The Effects of Cervical and Sacroiliac Mobilization Followed by Pilates-Based Training on Bruxism Severity, Perceived Stress, Pain Catastrophizing, Functional Capacity, and Proprioception in Individuals With Bruxism
This study investigated the effects of adding cervical and sacroiliac mobilization to a Pilates-based exercise program on pain, perceived stress, pain catastrophizing, kinesiophobia, jaw functional limitation, cervical range of motion, cervical joint position error, and sacroiliac joint screening findings in individuals with bruxism.
Thirty-eight participants were randomly allocated to a Pilates-only group (n=19) or a Manual Therapy + Pilates group (n=19).
Both groups completed an 8-week, twice-weekly Pilates protocol (16 sessions); the Manual Therapy + Pilates group additionally received cervical and sacroiliac mobilization.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Bruxism is a repetitive jaw-muscle activity associated with musculoskeletal and psychosocial dysfunction, including cervical spine impairment and altered proprioception.
This randomized study examined whether adding cervical and sacroiliac mobilization to a standardized Pilates-based exercise program produces greater improvements than Pilates alone.
Outcomes included pain intensity (VAS), perceived stress (PSS-10), pain catastrophizing (PCS), kinesiophobia (TSK-17), jaw functional limitation (JFLS-8), cervical range of motion (goniometry), cervical joint position error, and sacroiliac joint screening (Standing Forward Flexion Test, Gillet Test), assessed before and after the 8-week intervention.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ataşehir
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Istanbul, Ataşehir, Turkey (Türkiye), 34755
- Noi Physio Pilates Studio
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being between 18 and 65 years of age
- Being diagnosed with bruxism (awake bruxism and/or sleep bruxism) based on clinical presentation and self-reported symptoms
- Reporting symptoms such as jaw clenching, teeth grinding, masticatory muscle fatigue, or orofacial discomfort
- Voluntarily agreeing to participate in the study and providing written informed consent
- Having sufficient cognitive ability to understand and follow instructions
- Being physically capable of participating in a structured exercise program
- Not receiving any ongoing physiotherapy or rehabilitation program targeting the craniofacial, cervical, or lumbopelvic regions during the study period
Exclusion Criteria:
- History of surgical intervention involving the temporomandibular joint, cervical spine, or craniofacial region Presence of neurological, rheumatological, or systemic diseases that could affect movement, pain perception, or neuromuscular control Diagnosis of severe temporomandibular joint disorders that significantly limit jaw function or require specialized medical treatment Presence of acute musculoskeletal injury affecting the cervical spine, lumbar region, or lower extremities Current use of medications affecting neuromuscular function, such as muscle relaxants, sedatives, or psychotropic drugs Diagnosed psychiatric conditions that could interfere with participation or compliance with the study protocol Participation in any physiotherapy, rehabilitation, or structured exercise program targeting the craniofacial, cervical, or lumbopelvic regions during the study period Pregnancy, due to potential alterations in musculoskeletal and hormonal status Inability to attend regular sessions or complete the intervention protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Pilates-only
Participants completed an 8-week, twice-weekly Pilates-based exercise program (16 sessions, 30-40 minutes each).
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A structured Pilates-based exercise program targeting core stability, posture, and cervical control, performed twice weekly for 8 weeks (16 sessions total, 30-40 minutes per session).
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Experimental: Manual Therapy + Pilates
Participants received cervical and sacroiliac mobilization in addition to the same 8-week, twice-weekly Pilates-based exercise program (16 sessions, 30-40 minutes each).
|
A structured Pilates-based exercise program targeting core stability, posture, and cervical control, performed twice weekly for 8 weeks (16 sessions total, 30-40 minutes per session).
Manual mobilization techniques applied to the cervical spine and sacroiliac joint, performed in addition to the Pilates-based exercise program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity (VAS)
Time Frame: Baseline and after 8-week intervention
|
Pain intensity assessed using the Visual Analog Scale (0-10 cm), with higher scores indicating greater pain.
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Baseline and after 8-week intervention
|
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Perceived Stress (PSS-10)
Time Frame: Baseline and after 8-week intervention
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Perceived stress assessed using the Perceived Stress Scale-10 (PSS-10), with higher scores indicating greater perceived stress.
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Baseline and after 8-week intervention
|
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Pain Catastrophizing (PCS)
Time Frame: Baseline and after 8-week intervention
|
Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS), with higher scores indicating greater catastrophizing.
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Baseline and after 8-week intervention
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Cervical Joint Position Error
Time Frame: Baseline and after 8-week intervention
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Cervical proprioception assessed via joint position error (flexion, extension, right/left rotation), with smaller error indicating better proprioceptive accuracy.
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Baseline and after 8-week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Range of Motion
Time Frame: Baseline and after 8-week intervention
|
Cervical range of motion (flexion, extension, right/left lateral flexion, right/left rotation) assessed with goniometry.
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Baseline and after 8-week intervention
|
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Kinesiophobia (TSK-17)
Time Frame: Baseline and after 8-week intervention
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Fear of movement/kinesiophobia assessed using the Tampa Scale for Kinesiophobia-17 (TSK-17), with higher scores indicating greater kinesiophobia.
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Baseline and after 8-week intervention
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Sacroiliac Joint Screening
Time Frame: Baseline and after 8-week intervention
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Sacroiliac joint status assessed using the Standing Forward Flexion Test and the Gillet Test, categorized as negative or positive (with side/structure indicated when positive).
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Baseline and after 8-week intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 4, 2026
Primary Completion (Actual)
June 29, 2026
Study Completion (Actual)
June 29, 2026
Study Registration Dates
First Submitted
July 12, 2026
First Submitted That Met QC Criteria
July 12, 2026
First Posted (Actual)
July 16, 2026
Study Record Updates
Last Update Posted (Actual)
July 16, 2026
Last Update Submitted That Met QC Criteria
July 12, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Yeditepe U-122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared with other researchers, as the informed consent obtained from participants did not include provisions for sharing de-identified data beyond the scope of this study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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