Prospective, randomized, single-blinded study to test the applicability of extracorporeal shock wave therapy for the treatment of temporomandibular dysfunction.

Prospective, randomized, single-blinded study to test the applicability of extracorporeal shock wave therapy for the treatment of temporomandibular dysfunction. - ESWT_CMD

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027987

Enrollment

Registered

2022-01-31

Start date

2022-10-01

Completion date

Unknown

Last updated

2025-04-07

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: occlusal splint Group 2: occlusal splint + ESWT (extracorporeal shock wave therapy)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age > 18 years - Myofascial pain with or without mouth opening restriction based on the RDC/TMD (Research Diagnostic Criteria for TMD). - Uni- or bilateral temporomandibular joint disorders or disc displacement together with myofascial pain

Exclusion criteria

Exclusion criteria: - Polyarthritis/arthrosis - Acute trauma - TMJ infection - Surgical therapy or physical therapy, splint therapy, acupuncture within the last 3 months prior to the start of the study - Current use of pain medication

Design outcomes

Primary

Measure	Time frame
Number of painful (pressure) points (pain). Pain in everyday life (pain) are measured by means of: - DC/TMD Examination Questionnaire - Symptom Questionnaire and GCPS 2.0 (Graded Chronic Pain Scale)	—

Secondary

Measure	Time frame
* Mouth opening, laterotrusion (dysfunction). * Chronic pain (chronification) * Masticatory function in everyday life (dysfunction) * Psychological complaints (psyche) * Burden of the therapy (therapy evaluation) are measured with: - DC/TMD Examination Questionnaire - Symptom Questionnaire and GCPS 2.0 (Graded Chronic Pain Scale) - PHQ-9 (Patient Health Questionnaire) - PHQ-15 (Patient Health Questionnaire - Physical Symptoms) - Oral Behavior Checklist - JFLS-10 (Jaw Functional Limitation Scale) - GAD-7 (Generalized Anxiety Disorder Scale) and - Shock Wave Therapy Questionnaire	—

Measure

Time frame

* Mouth opening, laterotrusion (dysfunction). * Chronic pain (chronification) * Masticatory function in everyday life (dysfunction) * Psychological complaints (psyche) * Burden of the therapy (therapy evaluation) are measured with: - DC/TMD Examination Questionnaire - Symptom Questionnaire and GCPS 2.0 (Graded Chronic Pain Scale) - PHQ-9 (Patient Health Questionnaire) - PHQ-15 (Patient Health Questionnaire - Physical Symptoms) - Oral Behavior Checklist - JFLS-10 (Jaw Functional Limitation Scale) - GAD-7 (Generalized Anxiety Disorder Scale) and - Shock Wave Therapy Questionnaire

—

Countries

Germany

Contacts

Public ContactDiana Heimes

Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie der Universitätsmedizin Mainz

diana.heimes@unimedizin-mainz.de06131 17 5086

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026