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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03400462
Other study ID # KB-0012/83/16
Secondary ID
Status Completed
Phase N/A
First received January 1, 2018
Last updated January 12, 2018
Start date July 1, 2016
Est. completion date December 12, 2017

Study information

Verified date January 2018
Source Pomeranian Medical University Szczecin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to compare the effectiveness of myofascial pain treatment methods.


Description:

Three different metoda were taken into account: dry needling, occlusal sprint therapy and NSAID therapy.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 12, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- pain localized in the TMJ or in the preauricular area.

- no other analgesic treatment in the area of head and neck during last 12 months

Exclusion Criteria:

- inflammation in the oral cavity that emerge as a myofascial pain

- earlier splint therapy

- pharmacotherapy e.g oral contraception, hormone replacement therapy, -antidepressants

- systemic diseases e.g. rheumatic, metabolic

- lack of stability in the masticatory organ motor system

- masticatory organ injury

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
NSAID
Nimesulide has anti-inflammatory and analgesic properties. Like other NSAIDs it inhibits the action of COX . If prostaglandins can not be further synthesized, so there is no factor able to excite local nociceptors. According to t must be taken regularly for a minimum 2 weeks to achieve appropriate blood concentration.
Device:
oral appliance
The stabilization appliance used in this study was a removable device for maxillary arch, made of hard acrylic. Appliance was fitted over occlusal and incisal surfaces of the teeth and precisely contacted with the teeth of opposing arch. It provided canine disocclusion of the posterior teeth during eccentric movements.
Other:
dry needling
Equipment: acupuncture needle 0,6*13 e.g. Dragon Medical Device, Visits schedule:( 1st visit - Day 1st , 2nd visit- 7 days after the 1st, 3rd visit- 7 days after the 2nd)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pomeranian Medical University Szczecin

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale It is a continuous scale comprised of a horizontal line, usually 10 cm in length. "no pain" (score of 0) and "pain as bad as it could be (score of 10) 6 months
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