Treatment Efficiency of Acupuncture in Non Chronified Pain Patients With TMDs
Wirksamkeit Von Akupunktur Auf Den Nicht Chronifizierten Schmerz Bei Craniomandibulärer Dysfunktion - Eine Randomisierte, Placebokontrollierte Klinische Studie
1 other identifier
interventional
40
1 country
1
Brief Summary
Aim of this randomized clinical trial is to examine the treatment effectiveness of an acupuncture protocol in adult patients with non chronified TMDs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFebruary 3, 2016
February 1, 2016
2 years
October 1, 2015
February 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
current pain measured on Numerical Rating Scale
4 weeks
Secondary Outcomes (1)
maximum unassisted jaw opening in mm
4 weeks
Study Arms (2)
Verum
ACTIVE COMPARATORAcupuncture 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.
Placebo
PLACEBO COMPARATORPlacebo acupuncture therapy. For this study arm points outside of the meridians according to traditional chinese medicine, were chosen. Only intervention is the acupuncture therapy.
Interventions
Eligibility Criteria
You may qualify if:
- non chronified TMD pain
- written informed consent
You may not qualify if:
- dysfunctional TMD pain
- systematic diseases affecting the joints or pain perception
- pregnancy
- needle phobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poliklinik für Hals-Nasen-Ohrenheilkunde
Heidelberg, 69120, Germany
Related Publications (2)
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: 10812251BACKGROUNDDworkin 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: 1298767RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sinan Sen, Dr.med.dent.
Department of Orthodontics, University of Heidelberg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. dent.
Study Record Dates
First Submitted
October 1, 2015
First Posted
December 22, 2015
Study Start
April 1, 2014
Primary Completion
April 1, 2016
Study Completion
August 1, 2016
Last Updated
February 3, 2016
Record last verified: 2016-02