- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07708259
Effects of Cervical and Sacroiliac Mobilization Combined With Pilates on Bruxism
12 juli 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
38
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ataşehir
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Istanbul, Ataşehir, Turkiet (Türkiye), 34755
- Noi Physio Pilates Studio
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pain Intensity (VAS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Cervical Range of Motion
Tidsram: 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)
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
4 maj 2026
Primärt slutförande (Faktisk)
29 juni 2026
Avslutad studie (Faktisk)
29 juni 2026
Studieregistreringsdatum
Först inskickad
12 juli 2026
Först inskickad som uppfyllde QC-kriterierna
12 juli 2026
Första postat (Faktisk)
16 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Yeditepe U-122
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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