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Treatment Efficiency of Acupuncture in Non Chronified Pain Patients With TMDs

NCT02637544 — Not applicable, Unknown, 40 participants, University of Heidelberg Medical Center
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Wirksamkeit Von Akupunktur Auf Den Nicht Chronifizierten Schmerz Bei Craniomandibulärer Dysfunktion - Eine Randomisierte, Placebokontrollierte Klinische Studie

RegistryNCT02637544
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment40 (Estimated)
SponsorUniversity of Heidelberg Medical Center (Other)
ConditionsTemporomandibular Disorders
Interventionsacupuncture (Other)
Datesstart 2014-04-01, primary completion 2016-04-01 (estimated), completion 2016-08-01 (estimated), first posted 2015-12-22, last updated 2016-02-03
Locations1 site in Germany

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-Summary

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

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+Detailed 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.

+Arms and interventions

ArmTypeInterventionsDescription
VerumActive comparatorOther: acupunctureAcupuncture therapy. For this study arm following acupuncture points suitable for facial pain, according to traditional chinese medicine, were chosen: F2, F3, F34, IT3, IT19, S7, T21 and temporomandibular joint ear acupuncture points. Only intervention is the acupuncture therapy.
PlaceboPlacebo comparatorOther: acupuncturePlacebo acupuncture therapy. For this study arm points outside of the meridians according to traditional chinese medicine, were chosen. Only intervention is the acupuncture therapy.
  • acupuncture (Other): classical acupuncture therapy

+Outcome measures

Primary outcomes

  • current pain measured on Numerical Rating Scale [4 weeks]

Secondary outcomes

  • maximum unassisted jaw opening in mm [4 weeks]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Poliklinik für Hals-Nasen-OhrenheilkundeHeidelbergGermanyRecruiting

+Publications

  • 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):217-225. doi: 10.1016/S0304-3959(99)00304-8. PMID 10812251
  • Results publication: 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. No abstract available. PMID 1298767

+Investigators

My Notes