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CompletedNCT07913984Updated Nov 3, 2026

Dry Needling in the Management of Myofascial Trigger Points in the Orofacial Area: A Randomized Controlled Clinical Trial

An interventional study of Dry Needling and Sham Dry Needling in Dry Needling, Technique for the Treatment of the Myofascial Trigger Points, Dry Needling Technique and Temporomandibular Disorders (TMD), sponsored by Universidade do Porto. Completed at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Universidade do Porto · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 13 years 1 month after the study started (first participant enrolled Sep 2013, registered Oct 2026).
Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

A prospective, double-blinded, randomized, controlled clinical trial was conducted, in which Dry Needling (DN), sham DN (placebo), and counselling (gold standard) were compared, with specific objectives to assess both the benefits (e.g., pain reduction and functional improvement) and harms (e.g., adverse events) of each intervention.

02

Conditions studied

  • Dry Needling, Technique for the Treatment of the Myofascial Trigger Points
  • Dry Needling Technique
  • Temporomandibular Disorders (TMD)

Keywords

  • Dry Needling
  • Temporomandibular Disorders
  • Myofascial pain
03

In context

Temporomandibular Joint Disorders

624 studies on the registry are indexed under Temporomandibular Joint Disorders; 159 are open to participants now.

This study's enrollment of 30 is below the median of 46 across 442 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Universidade do Porto is the lead sponsor of 173 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with Temporomandibular Disorder(TMD) axis I diagnostic of myofascial pain and active Myofascial Trigger Points (MTrPs) in the masseter and/or temporalis muscles, with:

    1. localized spontaneous acute pain;
    2. presence of a taut, palpable band;
    3. localized tenderness in a precise point along taut band;
    4. referred pain area associated with the MTrP;
    5. replication of pain symptoms when the MTrP was pressured.

Exclusion criteria

Exclusion Criteria:

  • Patients \< 18 years old;
  • TMD diagnosis other than myofascial pain (RDC/TMD axis I or axis II) including arthralgias, disc displacement, among others;
  • Previously received acupuncture, Dry Needling or other TMD treatment in the last 6 months;
  • Patients who had a bleeding disorder;
  • Patients with needle phobia;
  • Patients with rheumatologic, metabolic, neurologic or psychiatric disorders.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Dry Needling (DN)

    DN therapy was applied in the Myofascial Trigger Points (MTrPs).

    Procedure: Dry Needling

  • Sham comparator
    Sham Dry Needling (DN)

    Sham DN was applied pricking the skin with a blunted needle after the skin was disinfected with alcohol and the trigger points determined using the same protocol as in the DN group.

    Procedure: Sham Dry Needling

  • Active comparator
    Counselling

    Patients received an educational and counseling program about Myofascial Pain and Myofascial Trigger Points.

    Behavioral: Counselling

Interventions

  • ProcedureDry Needling

    Dry Needling therapy was applied in the Myofascial Trigger Points (MTrPs) using standard single use sterile acupuncture needles 0,20mm x 13mm. The patient was placed in the supine position, the skin was disinfected with alcohol, the trigger points were determined, and the needle was inserted. When the needle penetrated the MTrP a movement "up and down" was repeated 3 to 5 times (without being completely removed). The procedure was repeated for each MTrPs present, including both active and latent points.

  • ProcedureSham Dry Needling

    Sham Dry Needling was applied pricking the skin with a blunted needle after the skin was disinfected with alcohol and the trigger points determined. The sham DN looked very similar to real DN except it didn't penetrate the skin.

  • BehavioralCounselling

    Counseling program about Myofascial Pain and Myofascial Trigger Points, emphasizing the benign nature of the condition. Patients were were instructed to relax their masticatory muscles, avoid clenching their teeth, refrain from chewing gum, biting their nails or pens, and to avoid other similar oral habits.

06

What researchers measure

Primary outcomes

  1. Pain intensity

    Pain intensity rated using a visual analogic scale (VAS).

    Time frame: Before and after intervention, 1 month after the last consultation

  2. Pain-free maximal jaw opening (PFJO)

    PFJO was assessed with a millimeter rule

    Time frame: Before and after intervention, 1 month after the last consultation

07

Study locations

1 site
  • Centro Hospitalar de São João
    Porto, 4200-319, Portugal
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07913984
Collaborators
Centro Hospitalar De São João, E.P.E.
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Sep 18, 2013
Primary completion
Feb 21, 2014
Completion
Mar 19, 2014
Last update
Nov 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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