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Completed

NCT Number: NCT07708259

Effects of Cervical and Sacroiliac Mobilization Combined With Pilates on 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Noi Physio Pilates Studio

Istanbul, Ataşehir, 34755, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pilates-Based Exercise Program

Behavioral

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).

Cervical and Sacroiliac Mobilization

Procedure

Manual mobilization techniques applied to the cervical spine and sacroiliac joint, performed in addition to the Pilates-based exercise program.

Primary outcomes

  1. 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.

  2. Perceived Stress (PSS-10)

    Time frame: Baseline and after 8-week intervention

    Perceived stress assessed using the Perceived Stress Scale-10 (PSS-10), with higher scores indicating greater perceived stress.

  3. 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.

  4. Cervical Joint Position Error

    Time frame: Baseline and after 8-week intervention

    Cervical proprioception assessed via joint position error (flexion, extension, right/left rotation), with smaller error indicating better proprioceptive accuracy.

Secondary outcomes

  1. 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.

  2. Kinesiophobia (TSK-17)

    Time frame: Baseline and after 8-week intervention

    Fear of movement/kinesiophobia assessed using the Tampa Scale for Kinesiophobia-17 (TSK-17), with higher scores indicating greater kinesiophobia.

  3. Sacroiliac Joint Screening

    Time frame: Baseline and after 8-week intervention

    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).

Sponsors and collaborators

Lead sponsor

Elif Tuğçe Çil

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

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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