Temporomandibular DisordersNCT02637544
Treatment Efficiency of Acupuncture in Non Chronified Pain Patients With TMDs
A study testing acupuncture in people with Temporomandibular Disorders, run by University of Heidelberg Medical Center at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non chronified TMD pain
- written informed consent
Who cannot join
- dysfunctional TMD pain
- systematic diseases affecting the joints or pain perception
- pregnancy
- needle phobia
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Poliklinik für Hals-Nasen-Ohrenheilkunde
Heidelberg, 69120
Serkan Sertel, PD Dr. med., serkan.sertel@med.uni-heidelberg.de
About this study
Official title: Wirksamkeit Von Akupunktur Auf Den Nicht Chronifizierten Schmerz Bei Craniomandibulärer Dysfunktion - Eine Randomisierte, Placebokontrollierte Klinische Studie
Aim of this randomized clinical trial is to examine the treatment effectiveness of an acupuncture protocol in adult patients with non chronified TMDs.
Read the 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.
- Conditions
- Temporomandibular Disorders
- Being tested
- acupuncture
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
classical acupuncture therapy
| Study group | Role | What they receive |
|---|---|---|
| Verum | Active comparator | Acupuncture 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. Receives: Other: acupuncture |
| Placebo | Placebo comparator | Placebo acupuncture therapy. For this study arm points outside of the meridians according to traditional chinese medicine, were chosen. Only intervention is the acupuncture therapy. Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
current pain measured on Numerical Rating Scale
Measured: 4 weeks
Secondary outcomes (1)
maximum unassisted jaw opening in mm
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startApr 2014
- Primary completionApr 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Heidelberg Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan Sen, University of Heidelberg Medical Center
- Investigators
- Sinan Sen, Dr.med.dent., Principal investigator, Department of Orthodontics, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637544
- Sponsor's protocol ID
- S-099/2014
- Status last verified
- Feb 2016
- First submitted
- 1 Oct 2015
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 10812251Dworkin 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.
PubMed 1298767
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wirksamkeit Von Akupunktur Auf Den Nicht Chronifizierten Schmerz Bei Craniomandibulärer Dysfunktion - Eine Randomisierte, Placebokontrollierte Klinische Studie
- ClinicalTrials.gov ID
- NCT02637544
- Acronym / sponsor ID
- S-099/2014
- Conditions
- Temporomandibular Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Heidelberg Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of this randomized clinical trial is to examine the treatment effectiveness of an acupuncture protocol in adult patients with non chronified TMDs.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Active comparator | Other: 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. |
| Placebo | Placebo comparator | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- non chronified TMD pain
- written informed consent
Key exclusion criteria (4 listed)
- dysfunctional TMD pain
- systematic diseases affecting the joints or pain perception
- pregnancy
- needle phobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureclassical acupuncture therapy | Other | Placebo, Verum |
Primary outcome
current pain measured on Numerical Rating Scale
Time frame: 4 weeks
1 secondary outcome
maximum unassisted jaw opening in mm
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Background: PubMed 10812251Ezzo 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.
- Results publication: PubMed 1298767Dworkin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sinan Sen, Dr.med.dent. principal investigator
Department of Orthodontics, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Temporomandibular Disorders, run by University of Heidelberg Medical Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikolaos Giannakopoulos, Dr.med.dent. (+491737373129, nik.giannakopoulos@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
current pain measured on Numerical Rating Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02637544, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.