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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02587182
Other study ID # CEU-011
Secondary ID
Status Completed
Phase N/A
First received October 22, 2015
Last updated June 2, 2016
Start date June 2015
Est. completion date November 2015

Study information

Verified date June 2016
Source CEU San Pablo University
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial Summary

The objective of the present study was to assess the effectiveness of deep dry needling in the masseter and temporalis MTrPs on pain, pressure pain threshold (PPT), range of motion and disability in patients with sleep bruxism and myofascial temporomandibular disorders.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Diagnosis of myofascial temporomandibular disorders

- Diagnosis of myofascial trigger point

- Diagnosis of sleep bruxism

Exclusion Criteria:

- insurmountable fear of needles

- any systematic joint or muscle disease

- bleeding disorders or

- prior physical therapy treatment

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Myofascial Pain
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
Deep Dry needling
The muscles were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the myofascial trigger point, eliciting local twitch responses in some insertions

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
CEU San Pablo University

Outcome

Type Measure Description Time frame Safety issue
Primary Pain: visual analog scale, ranging from 0mm (no pain) to 100mm (worst imaginable pain). 1 week Yes
Primary Pressure pain sensitivity: mechanical pressure algometer. 1 week Yes
Primary Range of motion: distance between the upper and lower central dental incisors was measured with a millimeter ruler. 1 week Yes
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