NCT02587182

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

5 months

First QC Date

October 22, 2015

Last Update Submit

June 2, 2016

Conditions

Myofascial Pain

Outcome Measures

Primary Outcomes (3)

  • Pain: visual analog scale, ranging from 0mm (no pain) to 100mm (worst imaginable pain).

    1 week

  • Pressure pain sensitivity: mechanical pressure algometer.

    1 week

  • Range of motion: distance between the upper and lower central dental incisors was measured with a millimeter ruler.

    1 week

Study Arms (1)

Dry needling

EXPERIMENTAL

Dry needling in the masseter and temporalis muscles

Device: Deep Dry needling

Interventions

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

Dry needling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of myofascial temporomandibular disorders
  • Diagnosis of myofascial trigger point
  • Diagnosis of sleep bruxism

You may not qualify if:

  • insurmountable fear of needles
  • any systematic joint or muscle disease
  • bleeding disorders or
  • prior physical therapy treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27697769DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 27, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

June 3, 2016

Record last verified: 2016-06