- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02587182
Effects of Dry Needling in Patients With Sleep Bruxism and Temporomandibular Disorders: a Prospective Case Series
June 2, 2016 updated by: CEU San Pablo University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dry needling
Dry needling in the masseter and temporalis muscles
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain: visual analog scale, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Time Frame: 1 week
|
1 week
|
Pressure pain sensitivity: mechanical pressure algometer.
Time Frame: 1 week
|
1 week
|
Range of motion: distance between the upper and lower central dental incisors was measured with a millimeter ruler.
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
October 22, 2015
First Submitted That Met QC Criteria
October 23, 2015
First Posted (Estimate)
October 27, 2015
Study Record Updates
Last Update Posted (Estimate)
June 3, 2016
Last Update Submitted That Met QC Criteria
June 2, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- CEU-011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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