- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07708259
Effects of Cervical and Sacroiliac Mobilization Combined With Pilates on Bruxism
12. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
38
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ataşehir
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Istanbul, Ataşehir, Tyrkia (Türkiye), 34755
- Noi Physio Pilates Studio
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. mai 2026
Primær fullføring (Faktiske)
29. juni 2026
Studiet fullført (Faktiske)
29. juni 2026
Datoer for studieregistrering
Først innsendt
12. juli 2026
Først innsendt som oppfylte QC-kriteriene
12. juli 2026
Først lagt ut (Faktiske)
16. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Yeditepe U-122
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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