Temporomandibular Joint Dysfunction; Myofascial Pain Syndrome; Orofacial Pain; Musculoskeletal DisordersNCT07321483
Reflex Therapy of Temporomandibular Dysfunctions
A study testing Dry needling and Standard rehabilitation in people with Temporomandibular Joint Dysfunction; Myofascial Pain Syndrome; Orofacial Pain; Musculoskeletal Disorders, run by Palacky University at 1 site in Czechia.
Trial summary
This study aims to evaluate the effectiveness of dry needling in patients with functional temporomandibular pain syndrome by comparing standard rehabilitation therapy alone with therapy combined with dry needling to reduce pain, improve jaw function and enhance quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Joint Dysfunction; Myofascial Pain Syndrome; Orofacial Pain; Musculoskeletal Disorders
- What is being tested?
- Dry needling and Standard rehabilitation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Dec 2025to 2 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosed with functional temporomandibular pain syndrome without structural temporomandibular joint damage.
- Aged ≥18 years.
- Stable health condition suitable for outpatient rehabilitation.
- Willingness to participate and ability to follow the therapeutic protocol.
Who cannot join
- Presence of degenerative, post-traumatic, or inflammatory changes in the temporomandibular joint.
- Cognitive or psychiatric disorders limiting cooperation.
- Lack of informed consent or non-compliance during treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dana Dvořáková, MSc. contact
Czechia1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences, Palacký University Olomouc, Czech Republic
Olomouc, 77900
PETR Konečný, Ph.D., M.D.; assoc.prof., +420604573931, petr.konecny@upol.cz
Dana Dvořáková, MSc., +420604573931, dana.dvorakova01@upol.cz
About this study
Official title: Evaluation of the Therapeutic Efficacy of Reflex Therapy Using Dry Needling in Patients With Functional Temporomandibular Pain Syndrome: A Prospective, Randomized, Controlled Pilot Study.
This study aims to evaluate the effectiveness of dry needling in patients with functional temporomandibular pain syndrome by comparing standard rehabilitation therapy alone with therapy combined with dry needling to reduce pain, improve jaw function and enhance quality of life.
Read the detailed description
This prospective, randomized, controlled pilot study aims to evaluate the therapeutic effects of dry needling in patients with functional temporomandibular pain syndrome. A total of 100 participants will be randomly assigned to two groups: an experimental group receiving standard rehabilitation combined with dry needling therapy, and a control group undergoing standard rehabilitation only. The intervention program will consist of ten outpatient rehabilitation sessions conducted over five weeks.
Outcome measures will include pain intensity (Visual Analogue Scale, VAS), temporomandibular joint range of motion, presence of joint sound phenomena, and quality of life assessed using the World Health Organization Quality of Life - BREF questionnaire (WHOQOL-BREF questionnaire). Measurements will be collected at baseline, immediately after the first therapy session, and upon completion of the treatment cycle.
Descriptive statistics will be used for data analysis. The Shapiro-Wilk test will assess data normality. Between-group differences will be analyzed using parametric (t-test) or nonparametric (Mann-Whitney, Wilcoxon) tests, depending on data distribution. Correlation analyses will be performed using Pearson's or Spearman's correlation coefficients. Statistical significance will be set at p < 0.05.
All statistical analyses will be conducted using IBM SPSS Statistics for Windows, version 29.0 (Armonk, NY, USA).
- Being tested
- Dry needling, Standard rehabilitation
- Keywords
- headache; temporomandibular disorders; dry needling; rehabilitation therapy; pain; quality of life, temporomandibular disorders; dry needling; rehabilitation therapy; pain; quality of life
- Medical subject headings
- Temporomandibular Joint Disorders, Myofascial Pain Syndromes, Facial Pain, Musculoskeletal Diseases, Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingProcedure or surgery
Also called reflex injection therapy of Trigger Point
One dry needling intervention targeting trigger points in the masseter and temporalis muscles during the first treatment session
Standard rehabilitationProcedure or surgery
Also called Standard Physical Rehabilitation Program
The therapy will include mobilization, soft tissue relaxation techniques, and specific exercises focused on improving temporomandibular joint mobility and reducing muscle tension.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: intervention with Dry Needling and Standard Rehabilitation) | Experimental | Participants in this group will receive standard outpatient rehabilitation therapy combined with Intervention: one dry needling intervention targeting trigger points in the masseter and temporalis muscles during the first treatment session. The rehabilitation program will include mobilization, soft tissue techniques, and targeted kinesiotherapy. Each participant will undergo ten outpatient rehabilitation sessions over five weeks (two sessions per week). Receives: Procedure: Dry needling; Procedure: Standard rehabilitation |
| Control Group - Standard Rehabilitation | Active comparator | Participants in this group will receive the same standard outpatient rehabilitation program as the experimental group, excluding the dry needling procedure. The therapy will include mobilization, soft tissue relaxation techniques, and specific exercises focused on improving temporomandibular joint mobility and reducing muscle tension Receives: Procedure: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Pain Intensity using the Visual Analogue Scale (VAS).
- Description: Evaluation of subjective pain intensity in the temporomandibular region assessed using the Visual Analogue Scale (VAS), a continuous scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate worse pain intensity.
- Measurement Type: Continuous (0-10 scale).
Measured: Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions).
Secondary outcomes (1)
Temporomandibular Joint (TMJ) Range of Motion, Joint Sound Phenomena and Quality of Life (WHOQOL-BREF)
- Description: Measurement of maximal mouth opening and mandibular movement range using a caliper to assess functional improvement of the TMJ.
- Measurement Type: Continuous (millimeters). and
- Description: Clinical assessment of the presence or absence of joint sounds (clicking, popping, or crepitation) during mandibular movement as an indicator of TMJ functional stability.
- Measurement Type: Categorical (present/absent). and
- Description: Evaluation of overall quality of life using the WHOQOL-BREF questionnaire, which assesses physical, psychological, social, and environmental domains.
- Measurement Type: Continuous (score-based)
Measured: Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start20 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion2 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint Dysfunction; Myofascial Pain Syndrome; Orofacial Pain; Musculoskeletal DisordersStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Konecny, Palacky University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321483
- Sponsor's protocol ID
- IGA_FZV_2025_015
- Status last verified
- Aug 2026
- First submitted
- 21 Nov 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy and institutional data protection policies
Publications
Quilghini C, Lefflot J, Buchholtz K. The effectiveness of physiotherapy for chronic headaches in patients with temporomandibular disorders: a systematic review. Front Rehabil Sci. 2025 Sep 23;6:1647927. doi: 10.3389/fresc.2025.1647927. eCollection 2025.
PubMed 41064810Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.
PubMed 26294683Konečný P, Havlíčková J, Elfmark M, Tvrdý P, Hanáková D, Jureček M. Effects of Rehabilitation in Patients with Temporomandibular Joint Disorders. Rehabil. Fyz. Lek. (2007) 14: 95-100.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Therapeutic Efficacy of Reflex Therapy Using Dry Needling in Patients With Functional Temporomandibular Pain Syndrome: A Prospective, Randomized, Controlled Pilot Study.
- ClinicalTrials.gov ID
- NCT07321483
- Acronym / sponsor ID
- IGA_FZV_2025_015
- Keywords
- headache; temporomandibular disorders; dry needling; rehabilitation therapy; pain; quality of life, temporomandibular disorders; dry needling; rehabilitation therapy; pain; quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 2 Aug 2027 (estimated)
- First posted
- 7 Jan 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.
This study aims to evaluate the effectiveness of dry needling in patients with functional temporomandibular pain syndrome by comparing standard rehabilitation therapy alone with therapy combined with dry needling to reduce pain, improve jaw function and enhance quality of life.
Detailed description
This prospective, randomized, controlled pilot study aims to evaluate the therapeutic effects of dry needling in patients with functional temporomandibular pain syndrome. A total of 100 participants will be randomly assigned to two groups: an experimental group receiving standard rehabilitation combined with dry needling therapy, and a control group undergoing standard rehabilitation only. The intervention program will consist of ten outpatient rehabilitation sessions conducted over five weeks.
Outcome measures will include pain intensity (Visual Analogue Scale, VAS), temporomandibular joint range of motion, presence of joint sound phenomena, and quality of life assessed using the World Health Organization Quality of Life - BREF questionnaire (WHOQOL-BREF questionnaire). Measurements will be collected at baseline, immediately after the first therapy session, and upon completion of the treatment cycle.
Descriptive statistics will be used for data analysis. The Shapiro-Wilk test will assess data normality. Between-group differences will be analyzed using parametric (t-test) or nonparametric (Mann-Whitney, Wilcoxon) tests, depending on data distribution. Correlation analyses will be performed using Pearson's or Spearman's correlation coefficients. Statistical significance will be set at p < 0.05.
All statistical analyses will be conducted using IBM SPSS Statistics for Windows, version 29.0 (Armonk, NY, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: intervention with Dry Needling and Standard Rehabilitation) | Experimental | Procedure: Dry needling, Procedure: Standard rehabilitationParticipants in this group will receive standard outpatient rehabilitation therapy combined with Intervention: one dry needling intervention targeting trigger points in the masseter and temporalis muscles during the first treatment session. The rehabilitation program will include mobilization, soft tissue techniques, and targeted kinesiotherapy. Each participant will undergo ten outpatient rehabilitation sessions over five weeks (two sessions per week). |
| Control Group - Standard Rehabilitation | Active comparator | Procedure: Standard rehabilitationParticipants in this group will receive the same standard outpatient rehabilitation program as the experimental group, excluding the dry needling procedure. The therapy will include mobilization, soft tissue relaxation techniques, and specific exercises focused on improving temporomandibular joint mobility and reducing muscle tension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with functional temporomandibular pain syndrome without structural temporomandibular joint damage.
- Aged ≥18 years.
- Stable health condition suitable for outpatient rehabilitation.
- Willingness to participate and ability to follow the therapeutic protocol.
Key exclusion criteria (3 listed)
- Presence of degenerative, post-traumatic, or inflammatory changes in the temporomandibular joint.
- Cognitive or psychiatric disorders limiting cooperation.
- Lack of informed consent or non-compliance during 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 |
|---|---|---|
| Dry needlingAlso: reflex injection therapy of Trigger PointOne dry needling intervention targeting trigger points in the masseter and temporalis muscles during the first treatment session | Procedure or surgery | Experimental Group: intervention with Dry Needling and Standard Rehabilitation) |
| Standard rehabilitationAlso: Standard Physical Rehabilitation ProgramThe therapy will include mobilization, soft tissue relaxation techniques, and specific exercises focused on improving temporomandibular joint mobility and reducing muscle tension. | Procedure or surgery | Control Group - Standard Rehabilitation, Experimental Group: intervention with Dry Needling and Standard Rehabilitation) |
Primary outcome
1. Pain Intensity using the Visual Analogue Scale (VAS).
Time frame: Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions).
* Description: Evaluation of subjective pain intensity in the temporomandibular region assessed using the Visual Analogue Scale (VAS), a continuous scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate worse pain intensity. * Measurement Type: Continuous (0-10 scale).
1 secondary outcome
Temporomandibular Joint (TMJ) Range of Motion, Joint Sound Phenomena and Quality of Life (WHOQOL-BREF)
Time frame: Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Results publication: PubMed 41064810Quilghini C, Lefflot J, Buchholtz K. The effectiveness of physiotherapy for chronic headaches in patients with temporomandibular disorders: a systematic review. Front Rehabil Sci. 2025 Sep 23;6:1647927. doi: 10.3389/fresc.2025.1647927. eCollection 2025.
- Results publication: PubMed 26294683Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.
- Results publicationKonečný P, Havlíčková J, Elfmark M, Tvrdý P, Hanáková D, Jureček M. Effects of Rehabilitation in Patients with Temporomandibular Joint Disorders. Rehabil. Fyz. Lek. (2007) 14: 95-100.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy and institutional data protection policies
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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.
Dana Dvořáková, MSc. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling and Standard rehabilitation in people with Temporomandibular Joint Dysfunction; Myofascial Pain Syndrome; Orofacial Pain; Musculoskeletal Disorders, run by Palacky University at 1 site in Czechia.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Aug 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petr Konečný, Ph.D, M.D., assoc.prof. (+420604573931, petr.konecny@upol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Pain Intensity using the Visual Analogue Scale (VAS). (time frame: Baseline (pre-intervention) Immediately after the first therapy session At completion of the treatment program (after 10 therapy sessions).). 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 NCT07321483, which also lists 3 linked publications.
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 11 Aug 2026.