Treatment Efficiency of Acupuncture in Non Chronified Pain Patients With TMDs

Temporomandibular Disorders Clinical Trial

Official title:

Wirksamkeit Von Akupunktur Auf Den Nicht Chronifizierten Schmerz Bei Craniomandibulärer Dysfunktion - Eine Randomisierte, Placebokontrollierte Klinische Studie

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02637544
• Other study ID #: S-099/2014
• Status: Recruiting
• Phase: N/A
• First received: October 1, 2015
• Last updated: February 2, 2016
• Start date: April 2014
• Est. completion date: August 2016

Study information

• Verified date: February 2016
• Source: University of Heidelberg Medical Center
• Contact: Nikolaos Giannakopoulos, Dr.med.dent.
• Phone: +491737373129
• Email: nik.giannakopoulos[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Aim of this randomized clinical trial is to examine the treatment effectiveness of an acupuncture protocol in adult patients with non chronified TMDs.

Description:

Therefore there are two treatment arms, acupuncture verum and acupuncture placebo. Investigators will evaluate for 4 weeks primary current pain, secondary the unassisted jaw opening.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• non chronified TMD pain

• written informed consent

Exclusion Criteria:

• dysfunctional TMD pain

• systematic diseases affecting the joints or pain perception

• pregnancy

• needle phobia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• acupuncture
classical acupuncture therapy

Locations

Country	Name	City	State
Germany	Poliklinik für Hals-Nasen-Ohrenheilkunde	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Heidelberg Medical Center

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. Review. — View Citation

Ezzo J, Berman B, Hadhazy VA, Jadad AR, Lao L, Singh BB. Is acupuncture effective for the treatment of chronic pain? A systematic review. Pain. 2000 Jun;86(3):217-25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	current pain measured on Numerical Rating Scale		4 weeks	No
Secondary	maximum unassisted jaw opening in mm		4 weeks	No