Myofascial Pain SyndromesNCT07706153
Comparative Analysis of Dry Needling Techniques for Orofacial Myofascial Pain
A study testing Dry needling in people with Myofascial Pain Syndromes and Facial Pain, run by Flávio Magno Gonçalves at 1 site in Brazil.
Trial summary
This study aims to compare the clinical effectiveness and individual comfort of three distinct dry needling techniques (dynamic, static, and hybrid) for managing orofacial myofascial pain. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndromes, Facial Pain, Trigger Points
- What is being tested?
- Dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2026to 1 Apr 2027
- Phase
- Interventional
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Myofascial Pain (with or without referred pain) in the masseter and/or temporalis muscles according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I
- Presence of at least one active trigger point in a taut band reproducing the chief complaint
- Baseline pain intensity ≥ 2 on the VAS in the last two weeks
- Confirmed pressure pain threshold (PPT ≤ 1.5 kg/cm²)
- Signed informed consent form
Who cannot join
- TMD treatment in the last 3 months (physical therapy, needling, laser therapy) or Botulinum Toxin injection in the orofacial region within 12 months
- Continuous systemic use of analgesics, anti-inflammatories, or muscle relaxants
- Diagnosis of fibromyalgia, systemic rheumatic diseases, neurological disorders, or neuropathic pain
- Needle phobia (belonephobia), coagulation disorders, or use of anticoagulant drugs
- Active skin or odontogenic infections in the application area
- History of recent facial trauma or orthognathic/joint surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Center for Diagnosis and Treatment of the Temporomandibular Joint, Universidade Tuiuti do Paraná (CDATM-UTP)
Curitiba, Paraná, 80430140
Flávio Magno Gonçalves, Professor, 55 42 98816-7711, flaviomagno93@yahoo.com.br
About this study
Official title: Comparative Analysis of the Effectiveness and Comfort of Different Dry Needling Techniques in the Treatment of Orofacial Myofascial Pain: A Randomized Clinical Trial
This study aims to compare the clinical effectiveness and individual comfort of three distinct dry needling techniques (dynamic, static, and hybrid) for managing orofacial myofascial pain. Myofascial pain is a highly prevalent manifestation of temporomandibular disorders (TMD), characterized by painful trigger points in the masticatory muscles, such as the masseter and temporalis, which cause pain, muscle tenderness, and jaw movement limitations. While dry needling is widely recognized as an effective minimally invasive therapy to deactivate these trigger points, there is still a lack of consensus in scientific literature regarding the standardization of application protocols.
To address this gap, this randomized, triple-blind, parallel-group clinical trial will enroll 45 individuals diagnosed with myofascial pain according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Participants will be randomly allocated into three equal groups (15 individuals per group): Group 1 will receive dynamic dry needling (fanning technique); Group 2 will receive static dry needling (needle kept in situ for 10 minutes); and Group 3 will receive a hybrid approach (combining an initial static period followed by dynamic manipulation).
The primary outcome will evaluate changes in self-reported pain intensity using a Visual Analog Scale (VAS) from baseline to 7 days post-intervention. Secondary outcomes will assess changes in pressure pain thresholds (PPT) via digital algometry, mandibular range of motion via digital caliper measurements, and the subjective perception of comfort and acceptability of each technique. Evaluations will be conducted at baseline, immediately post-intervention, at 7 days, and at 15 days of follow-up. The findings are expected to contribute to the standardization of more effective and comfortable clinical protocols for managing orofacial pain.
- Conditions
- Myofascial Pain Syndromes, Facial Pain, Trigger Points
- Being tested
- Dry needling
- Keywords
- dry needling, orofacial pain, myofascial pain syndromes
- Medical subject headings
- Myofascial Pain Syndromes, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingProcedure or surgery
Dry needling therapy targeted at active myofascial trigger points in masseter and temporalis muscles. Sterile, disposable, stainless steel needles (0.25x25mm or 0.25x30mm) will be used based on muscle depth. Procedures will be performed by a single operator with the individual in a supine position, following strict 70% alcohol antisepsis.
Mechanical manipulation follows three randomized protocols:
- Dynamic: Fast-in and fast-out needle manipulation (Hong's technique) in a fanning shape until local twitch responses cease or tolerance limit is reached.
- Static: Direct insertion into the trigger point, remaining completely static in situ for 10 minutes without further stimulation.
- Hybrid: Direct needle insertion kept static for 5 minutes for initial desensitization, followed by a brief period of dynamic fanning manipulation.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Dry Needling | Active comparator | Individuals will receive fast-in and fast-out needle manipulation (Hong's technique) in a fanning shape inside the trigger point of the masseter and/or temporalis muscles. The procedure continues until local twitch responses cease or the individual's tolerance limit is reached. Receives: Procedure: Dry needling |
| Static Dry Needling | Active comparator | The needle will be inserted directly into the core of the active trigger point in the masseter and/or temporalis muscles and will remain completely static in situ for 10 minutes, focusing on neurophysiological modulation without further mechanical stimulation. Receives: Procedure: Dry needling |
| Hybrid Dry Needling | Active comparator | A combination protocol where the needle is inserted into the trigger point and kept static for 5 minutes for initial desensitization, followed by a brief period of dynamic fanning manipulation (fast-in and fast-out). Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Self-Reported Orofacial Pain Intensity
Evaluated using a 100 mm Visual Analog Scale (VAS), where 0 mm indicates "no pain" and 100 mm indicates the "worst imaginable pain". The individual marks their current pain perception on the scale. The score is determined by measuring the distance from the left anchor to the individual's mark.
Measured: Baseline (T0) and 7 days post-intervention (T2). (This is the primary endpoint to identify mid-term clinical relevance).
Secondary outcomes (2)
Change from Baseline in Pressure Pain Threshold (PPT)
Measured using a calibrated digital pressure algometer equipped with a 1 cm² rubber tip applied perpendicularly over the active trigger point. Pressure increases constantly at a rate of 1.5 kg/cm²/second until the individual reports that the pressure sensation turns into pain. Higher values (in kg/cm²) indicate lower mechanical pain sensitivity.
Measured: Baseline (T0), 7 days post-intervention (T2), and 15 days post-intervention (T3).
Change from Baseline in Mandibular Range of Motion
Functional assessment measuring maximum functional mouth opening, maximum assisted mouth opening, protrusion, and lateralities (all in millimeters) using a high-precision digital caliper.
Measured: Baseline (T0), 7 days post-intervention (T2), and 15 days post-intervention (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flávio Magno Gonçalves
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Flávio Magno Gonçalves, Tuiuti University of Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706153
- Sponsor's protocol ID
- NEC 02
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I will analyze any request and will decide later