Influence of osteopathic intervention on pain symptoms and the autonomic nervous system of patients with craniomandibular dysfunction (CMD)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033196

Enrollment

Registered

2025-01-24

Start date

2026-09-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K07.6

Interventions

Group 1: Standard physiotherapeutic/orthodontic treatment of CMD: over one month at two-week intervals, i.e. three sessions of 30 minutes each Group 2: Standard physiotherapeutic/orthodontic treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - adults aged 18 and over - (Dental) medical CMD diagnosis (ICD-10: K07.6) - Study-relevant complaints for at least three months

Exclusion criteria

Exclusion criteria: - Wearing a pacemaker or atrial fibrillation (queried as part of the medical history) - higher-grade cardiac arrhythmia

Design outcomes

Primary

Measure	Time frame
Visual Analogue Pain Scale (VAS) in self report on a 100 mm long line after three months	—

Secondary

Measure	Time frame
Parameters of the autonomic nervous system based on a heart rate variability analysis (before and after each of the three treatments): - Mean heart rate (beats/min) - Standard deviation of the RR intervals originating from a sinus rhythm (Standard Deviation Normal to Normal/SDNN, parameter of overall variability) - Square root of the mean value of the squared deviations of neighboring RR intervals (Root Mean Square of Successive Differences/RMSSD, parameter of parasympathetic activity) - Stress index (SI, parameter of sympathetic activity) - Short-term index alpha1 of the trend-adjusted fluctuation analysis (parameter of the fractal organization of the VNS) The following self-reports according to Reißmann, 2019 at baseline and after one months treatment and at 3 months follow-up: - Graded Chronic Pain Status: Von Korff, Dworkin & LeReche, 1990 - Jaw Functional Limitation Scale (JFLS): Ohrbach, Larsson, & List, 2008 - Oral Health Impact Profile (OHIP G-5 ): John, Micheelis, & Biffar, 2004 - Perceived Stress Scale Cohen (PSS-10) : Klein et al, 2016 - Patient Health Questionnaire-4 (PHQ-4): Löwe et al, 2010	—

Measure

Time frame

Parameters of the autonomic nervous system based on a heart rate variability analysis (before and after each of the three treatments): - Mean heart rate (beats/min) - Standard deviation of the RR intervals originating from a sinus rhythm (Standard Deviation Normal to Normal/SDNN, parameter of overall variability) - Square root of the mean value of the squared deviations of neighboring RR intervals (Root Mean Square of Successive Differences/RMSSD, parameter of parasympathetic activity) - Stress index (SI, parameter of sympathetic activity) - Short-term index alpha1 of the trend-adjusted fluctuation analysis (parameter of the fractal organization of the VNS) The following self-reports according to Reißmann, 2019 at baseline and after one months treatment and at 3 months follow-up: - Graded Chronic Pain Status: Von Korff, Dworkin & LeReche, 1990 - Jaw Functional Limitation Scale (JFLS): Ohrbach, Larsson, & List, 2008 - Oral Health Impact Profile (OHIP G-5 ): John, Micheelis, & Biffar, 2004 - Perceived Stress Scale Cohen (PSS-10) : Klein et al, 2016 - Patient Health Questionnaire-4 (PHQ-4): Löwe et al, 2010

—

Countries

Germany

Contacts

Public ContactBenedict Breunig

osteo Darmstadt

breunig@osteo-darmstadt.de+49 6151 - 62 77 555

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026