NCT07708259

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 12, 2026

Last Update Submit

July 12, 2026

Conditions

Keywords

manual therapyBruxismCervical MobilizationSacroiliac JointPilatesProprioception

Outcome Measures

Primary Outcomes (4)

  • Pain Intensity (VAS)

    Pain intensity assessed using the Visual Analog Scale (0-10 cm), with higher scores indicating greater pain.

    Baseline and after 8-week intervention

  • Perceived Stress (PSS-10)

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

    Baseline and after 8-week intervention

  • Pain Catastrophizing (PCS)

    Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS), with higher scores indicating greater catastrophizing.

    Baseline and after 8-week intervention

  • Cervical Joint Position Error

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

    Baseline and after 8-week intervention

Secondary Outcomes (3)

  • Cervical Range of Motion

    Baseline and after 8-week intervention

  • Kinesiophobia (TSK-17)

    Baseline and after 8-week intervention

  • Sacroiliac Joint Screening

    Baseline and after 8-week intervention

Study Arms (2)

Pilates-only

ACTIVE COMPARATOR

Participants completed an 8-week, twice-weekly Pilates-based exercise program (16 sessions, 30-40 minutes each).

Behavioral: Pilates-Based Exercise Program

Manual Therapy + Pilates

EXPERIMENTAL

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).

Behavioral: Pilates-Based Exercise ProgramProcedure: Cervical and Sacroiliac Mobilization

Interventions

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 Therapy + PilatesPilates-only

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

Manual Therapy + Pilates

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noi Physio Pilates Studio

Istanbul, Ataşehir, 34755, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ASSISTANT PROF. DR.

Study Record Dates

First Submitted

July 12, 2026

First Posted

July 16, 2026

Study Start

May 4, 2026

Primary Completion

June 29, 2026

Study Completion

June 29, 2026

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations