Temporomandibular Disorders (TMD)NCT07820488
Adjunctive Acupuncture for Persistent Myofascial Temporomandibular Disorder Pain
A study testing Adjunctive Acupuncture in people with Temporomandibular Disorders (TMD) and Myofascial Pain - Dysfunction Syndrome of TMJ, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Temporomandibular disorders (TMDs) can cause persistent pain in the jaw muscles and limitations in jaw function. Occlusal splints are commonly used to manage these symptoms, but some patients continue to experience pain despite long-term splint use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders (TMD), Myofascial Pain - Dysfunction Syndrome of TMJ
- What is being tested?
- Adjunctive Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jul 2025to 1 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Ability to understand the study procedures and provide written informed consent.
- Diagnosis of myalgia according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I.
- Persistent or recurrent pain in the masseter and/or temporalis muscles for more than 12 months, including pain during the 30 days before enrollment, with muscular pain confirmed by clinical examination.
- Use of a maxillary full-arch stabilization splint for at least five consecutive years before enrollment.
- Persistence of temporomandibular disorder-related muscular pain despite ongoing occlusal splint use.
Who cannot join
- History of significant trauma to the temporomandibular joint.
- Poorly controlled systemic metabolic disease.
- Active cancer.
- Pregnancy.
- Significant neurological disorder.
- Use of medications affecting neuromuscular function during the 30 days before enrollment.
- Needle phobia.
- Inability to comply with the intervention and assessment schedule.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculty of Dental Medicine, university of Porto
Porto, Porto District, 4200-393
About this study
Official title: Short-Term Clinical and Electromyographic Changes Following Adjunctive Acupuncture in Adults With Persistent Myofascial Temporomandibular Disorder Pain Despite Long-Term Occlusal Splint Use: An Exploratory Single-Arm Pre-Post Study
Temporomandibular disorders (TMDs) can cause persistent pain in the jaw muscles and limitations in jaw function. Occlusal splints are commonly used to manage these symptoms, but some patients continue to experience pain despite long-term splint use.
The purpose of this exploratory study was to describe short-term changes after adding acupuncture to ongoing occlusal splint therapy in adults with persistent myofascial TMD pain. The study included 30 adults who had experienced pain in the masseter and/or temporalis muscles for more than 12 months and had used a maxillary full-arch stabilization splint for at least five consecutive years while remaining symptomatic.
Read more
All participants continued their occlusal splint therapy and received four 30-minute acupuncture sessions, administered once per week. Assessments were performed before the first acupuncture session and after the fourth session. The assessed outcomes were pain intensity, the amount of pressure required to produce pain in the jaw muscles, maximum mouth opening, and the electrical activity of the masseter and temporalis muscles.
All participants received the same intervention, and there was no control or comparison group. The study was therefore designed to characterize short-term changes within participants rather than to determine whether acupuncture was superior to another treatment or whether it directly caused the observed changes.
- Being tested
- Adjunctive Acupuncture
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunctive AcupunctureProcedure or surgery
Participants received four acupuncture sessions administered once per week by a practitioner with specific training and experience in acupuncture. Each session lasted 30 minutes. Sterile, single-use stainless-steel needles measuring 0.25 mm × 25 mm were inserted bilaterally at LI4, ST5, ST6, ST7, and ST8. After skin disinfection with 70% alcohol, needles were inserted perpendicularly to a depth of approximately 10-20 mm, adjusted according to the anatomical site and tissue thickness, with stimulation intended to elicit the de qi sensation. Acupuncture was provided as an adjunct to the participants' ongoing maxillary full-arch stabilization splint therapy.
| Study group | Role | What they receive |
|---|---|---|
| Adjunctive Acupuncture With Ongoing Occlusal Splint Therapy | Experimental | Participants who remained symptomatic despite at least five years of maxillary full-arch stabilization splint use continued their existing splint regimen and received four 30-minute acupuncture sessions administered once per week. Acupuncture was performed bilaterally at LI4, ST5, ST6, ST7, and ST8. Clinical and surface electromyographic outcomes were assessed before the first acupuncture session and after the fourth session. Receives: Procedure: Adjunctive Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Assessed With the 11-Point Numeric Rating Scale
Participants rated their current orofacial pain intensity using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable). Change was calculated as the post-intervention score minus the baseline score. Negative change values indicate a reduction in pain intensity.
Measured: Baseline and week 5.
Secondary outcomes (6)
Change in Pressure Pain Threshold of the Masseter and Temporalis Muscles
Pressure pain threshold was measured in kilopascals (kPa) using a digital algometer applied perpendicularly to the skin over the masseter and temporalis muscles. Participants indicated when increasing pressure was first perceived as painful. Measurements were obtained bilaterally for both muscles. Change was calculated as the post-intervention value minus the baseline value. Positive change values indicate an increased pressure pain threshold and reduced pressure pain sensitivity.
Measured: Baseline and week 5.
Change in Maximum Mouth Opening
Maximum mouth opening was measured in millimeters using a calibrated ruler placed between the incisal edges of the anterior teeth. Participants were assessed while seated with the Frankfurt plane parallel to the floor. Change was calculated as the post-intervention value minus the baseline value. Positive change values indicate increased maximum mouth opening.
Measured: Baseline and week 5.
Change in Surface Electromyographic Root Mean Square Amplitude at Mandibular Rest
Surface electromyographic activity was recorded bilaterally from the superficial masseter and anterior temporalis muscles while the mandible was in the postural rest position. Three 5-second recordings were obtained, and the root mean square amplitude was calculated over the interval between 2 and 4 seconds. Change was calculated as the post-intervention value minus the baseline value. Negative change values indicate lower electromyographic amplitude.
Measured: Baseline and week 5.
Change in Surface Electromyographic Peak Amplitude at Mandibular Rest
Surface electromyographic activity was recorded bilaterally from the superficial masseter and anterior temporalis muscles while the mandible was in the postural rest position. Three 5-second recordings were obtained, and peak amplitude was defined as the highest amplitude recorded during the interval between 2 and 4 seconds. Change was calculated as the post-intervention value minus the baseline value. Negative change values indicate lower peak electromyographic amplitude.
Measured: Baseline and week 5.
Change in Surface Electromyographic Root Mean Square Amplitude During Maximum Intercuspation
Surface electromyographic activity was recorded bilaterally from the superficial masseter and anterior temporalis muscles during maximum intercuspation. Parafilm M was positioned bilaterally in the molar region, and participants performed a 5-second maximum voluntary contraction. Three recordings were obtained, and the root mean square amplitude was calculated over the interval between 2 and 4 seconds. Change was calculated as the post-intervention value minus the baseline value.
Measured: Baseline and week 5.
Change in Surface Electromyographic Peak Amplitude During Maximum Intercuspation
Surface electromyographic activity was recorded bilaterally from the superficial masseter and anterior temporalis muscles during maximum intercuspation. Parafilm M was positioned bilaterally in the molar region, and participants performed a 5-second maximum voluntary contraction. Three recordings were obtained, and peak amplitude was defined as the highest amplitude recorded during the interval between 2 and 4 seconds. Change was calculated as the post-intervention value minus the baseline value.
Measured: Baseline and week 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Jul 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820488
- Sponsor's protocol ID
- FMDUP-ACUTMD-2025
- Other IDs
- 10/2025
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Clinical and Electromyographic Changes Following Adjunctive Acupuncture in Adults With Persistent Myofascial Temporomandibular Disorder Pain Despite Long-Term Occlusal Splint Use: An Exploratory Single-Arm Pre-Post Study
- ClinicalTrials.gov ID
- NCT07820488
- Acronym / sponsor ID
- FMDUP-ACUTMD-2025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 15 Sep 2026 (actual)
- 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.
Temporomandibular disorders (TMDs) can cause persistent pain in the jaw muscles and limitations in jaw function. Occlusal splints are commonly used to manage these symptoms, but some patients continue to experience pain despite long-term splint use.
The purpose of this exploratory study was to describe short-term changes after adding acupuncture to ongoing occlusal splint therapy in adults with persistent myofascial TMD pain. The study included 30 adults who had experienced pain in the masseter and/or temporalis muscles for more than 12 months and had used a maxillary full-arch stabilization splint for at least five consecutive years while remaining symptomatic.
All participants continued their occlusal splint therapy and received four 30-minute acupuncture sessions, administered once per week. Assessments were performed before the first acupuncture session and after the fourth session. The assessed outcomes were pain intensity, the amount of pressure required to produce pain in the jaw muscles, maximum mouth opening, and the electrical activity of the masseter and temporalis muscles.
All participants received the same intervention, and there was no control or comparison group. The study was therefore designed to characterize short-term changes within participants rather than to determine whether acupuncture was superior to another treatment or whether it directly caused the observed changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjunctive Acupuncture With Ongoing Occlusal Splint Therapy | Experimental | Procedure: Adjunctive AcupunctureParticipants who remained symptomatic despite at least five years of maxillary full-arch stabilization splint use continued their existing splint regimen and received four 30-minute acupuncture sessions administered once per week. Acupuncture was performed bilaterally at LI4, ST5, ST6, ST7, and ST8. Clinical and surface electromyographic outcomes were assessed before the first acupuncture session and after the fourth session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Ability to understand the study procedures and provide written informed consent.
- Diagnosis of myalgia according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I.
- Persistent or recurrent pain in the masseter and/or temporalis muscles for more than 12 months, including pain during the 30 days before enrollment, with muscular pain confirmed by clinical examination.
- Use of a maxillary full-arch stabilization splint for at least five consecutive years before enrollment.
Key exclusion criteria (8 listed)
- History of significant trauma to the temporomandibular joint.
- Poorly controlled systemic metabolic disease.
- Active cancer.
- Pregnancy.
- Significant neurological disorder.
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 |
|---|---|---|
| Adjunctive AcupunctureParticipants received four acupuncture sessions administered once per week by a practitioner with specific training and experience in acupuncture. Each session lasted 30 minutes. Sterile, single-use stainless-steel needles measuring 0.25 mm × 25 mm were inserted bilaterally at LI4, ST5, ST6, ST7, and ST8. After skin disinfection with 70% alcohol, needles were inserted perpendicularly to a depth of approximately 10-20 mm, adjusted according to the anatomical site and tissue thickness, with stimulation intended to elicit the de qi sensation. Acupuncture was provided as an adjunct to the participants' ongoing maxillary full-arch stabilization splint therapy. | Procedure or surgery | Adjunctive Acupuncture With Ongoing Occlusal Splint Therapy |
Primary outcome
Change in Pain Intensity Assessed With the 11-Point Numeric Rating Scale
Time frame: Baseline and week 5.
Participants rated their current orofacial pain intensity using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable). Change was calculated as the post-intervention score minus the baseline score. Negative change values indicate a reduction in pain intensity.
6 secondary outcomes
Change in Pressure Pain Threshold of the Masseter and Temporalis Muscles
Time frame: Baseline and week 5.
Change in Maximum Mouth Opening
Time frame: Baseline and week 5.
Change in Surface Electromyographic Root Mean Square Amplitude at Mandibular Rest
Time frame: Baseline and week 5.
Change in Surface Electromyographic Peak Amplitude at Mandibular Rest
Time frame: Baseline and week 5.
Change in Surface Electromyographic Root Mean Square Amplitude During Maximum Intercuspation
Time frame: Baseline and week 5.
Change in Surface Electromyographic Peak Amplitude During Maximum Intercuspation
Time frame: Baseline and week 5.
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 15 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Temporomandibular Disorders (TMD)
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjunctive Acupuncture in people with Temporomandibular Disorders (TMD) and Myofascial Pain - Dysfunction Syndrome of TMJ, run by Universidade do Porto at 1 site in Portugal.
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 6 inclusion and 8 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in Pain Intensity Assessed With the 11-Point Numeric Rating Scale (time frame: Baseline and week 5.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026.