- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07708259
Effects of Cervical and Sacroiliac Mobilization Combined With Pilates on Bruxism
12. juli 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
38
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ataşehir
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Istanbul, Ataşehir, Tyrkiet (Türkiye), 34755
- Noi Physio Pilates Studio
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: 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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Eksperimentel: 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).
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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).
Manual mobilization techniques applied to the cervical spine and sacroiliac joint, performed in addition to the Pilates-based exercise program.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pain Intensity (VAS)
Tidsramme: Baseline and after 8-week intervention
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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)
Tidsramme: 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)
Tidsramme: Baseline and after 8-week intervention
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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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cervical Range of Motion
Tidsramme: Baseline and after 8-week intervention
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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)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
4. maj 2026
Primær færdiggørelse (Faktiske)
29. juni 2026
Studieafslutning (Faktiske)
29. juni 2026
Datoer for studieregistrering
Først indsendt
12. juli 2026
Først indsendt, der opfyldte QC-kriterier
12. juli 2026
Først opslået (Faktiske)
16. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Yeditepe U-122
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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