Myofascial PainNCT02587182
Effects of Dry Needling in Patients With Sleep Bruxism and Temporomandibular Disorders: a Prospective Case Series
A study testing Deep Dry needling in people with Myofascial Pain, run by CEU San Pablo University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain
- What is being tested?
- Deep Dry needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Nov 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of myofascial temporomandibular disorders
- Diagnosis of myofascial trigger point
- Diagnosis of sleep bruxism
Who cannot join
- insurmountable fear of needles
- any systematic joint or muscle disease
- bleeding disorders or
- prior physical therapy treatment
About this study
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.
- Conditions
- Myofascial Pain
- Being tested
- Deep Dry needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Dry needlingDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Dry needling in the masseter and temporalis muscles Receives: Device: Deep Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: visual analog scale, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Measured: 1 week
Pressure pain sensitivity: mechanical pressure algometer.
Measured: 1 week
Range of motion: distance between the upper and lower central dental incisors was measured with a millimeter ruler.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial PainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587182
- Sponsor's protocol ID
- CEU-011
- Status last verified
- Jun 2016
- First submitted
- 22 Oct 2015
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Blasco-Bonora PM, Martin-Pintado-Zugasti A. Effects of myofascial trigger point dry needling in patients with sleep bruxism and temporomandibular disorders: a prospective case series. Acupunct Med. 2017 Mar;35(1):69-74. doi: 10.1136/acupmed-2016-011102. Epub 2016 Oct 3.
PubMed 27697769
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling in Patients With Sleep Bruxism and Temporomandibular Disorders: a Prospective Case Series
- ClinicalTrials.gov ID
- NCT02587182
- Acronym / sponsor ID
- CEU-011
- Conditions
- Myofascial Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Oct 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Device: Deep Dry needlingDry needling in the masseter and temporalis muscles |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of myofascial temporomandibular disorders
- Diagnosis of myofascial trigger point
- Diagnosis of sleep bruxism
Key exclusion criteria (4 listed)
- insurmountable fear of needles
- any systematic joint or muscle disease
- bleeding disorders or
- prior physical therapy treatment
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 |
|---|---|---|
| Deep Dry needlingThe muscles were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the myofascial trigger point, eliciting local twitch responses in some insertions | Device | Dry needling |
Primary outcome
Pain: visual analog scale, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Time frame: 1 week
Pressure pain sensitivity: mechanical pressure algometer.
Time frame: 1 week
Range of motion: distance between the upper and lower central dental incisors was measured with a millimeter ruler.
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Derived from this study: PubMed 27697769Blasco-Bonora PM, Martin-Pintado-Zugasti A. Effects of myofascial trigger point dry needling in patients with sleep bruxism and temporomandibular disorders: a prospective case series. Acupunct Med. 2017 Mar;35(1):69-74. doi: 10.1136/acupmed-2016-011102. Epub 2016 Oct 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Dry needling in people with Myofascial Pain, run by CEU San Pablo University.
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 3 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: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain: visual analog scale, ranging from 0mm (no pain) to 100mm (worst imaginable pain). (time frame: 1 week). The study lists 3 primary outcomes in all. 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 NCT02587182, which also lists 1 linked publication.
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 Jun 2016.