Interventional rehabilitation for jaw joint problems
| ISRCTN | ISRCTN17648638 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17648638 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Palacký University Olomouc |
| Funder | Univerzita Palackého v Olomouci |
- Submission date
- 20/10/2025
- Registration date
- 24/10/2025
- Last edited
- 23/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Temporomandibular disorders (TMD) affect about 5–12% of the population and represent the second most common source of musculoskeletal pain after low back pain. The myofascial form of TMD is associated with pain, limited mobility, and the presence of trigger points in the masticatory muscles. Standard treatment includes soft tissue techniques, joint mobilisation, targeted exercise and pharmacotherapy. Dry needling is a modern therapeutic approach focused on the deactivation of trigger points and modulation of pain.
The aim of this study is to evaluate the effectiveness of combining dry needling with standard rehabilitation compared to standard rehabilitation alone in patients with functional temporomandibular pain syndrome.
The combination of both methods may result in a greater reduction of pain and improvement of functional parameters compared to standard rehabilitation alone.
Who can participate?
Patients aged 18 years and over with functional temporomandibular disorder
What does the study involve?
Participants are randomly allocated to one of two groups:
Experimental group: standard outpatient rehabilitation program combined with dry needling applied to trigger points in the masseter and temporalis muscles during the first treatment session.
Control group: standard outpatient rehabilitation without dry needling.
Participants will undergo an evaluation of treatment effects using pain intensity scales, range of motion measurements, and quality of life assessments before and after therapy.
What are the possible benefits and risks of participating?
The main benefit is an objective evaluation of improvement in jaw function and pain reduction. No significant risks are expected.
Where is the study run from?
Palacký University Olomouc (Czech Republic)
When is the study starting and how long is it expected to run for?
January 2024 to June 2026
Who is funding the study?
Palacký University Olomouc (Czech Republic)
Who is the main contact?
Petr Konečný, petr.konecny@upol.cz
Contact information
Public, Scientific, Principal investigator
Hněvotínksá 3
Olomouc
77900
Czech Republic
 ORCID ID |
0000-0002-4047-9437 |
|---|---|
| Phone | +420 (0)604573931 |
| petr.konecny@upol.cz |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional prospective parallel-group randomized controlled trial with concealed allocation, assessor blinding, and an active control |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Reflex therapy of temporomandibular dysfunctions – randomized controlled pilot study |
| Study objectives | We hypothesise that combining dry needling with standard rehabilitation will result in greater improvement in pain reduction and functional outcomes compared to standard rehabilitation alone. |
| Ethics approval(s) |
Approved 07/01/2024, Ethics Committee of the Faculty of Health Sciences, Palacký University Olomouc (Hnevotinská 3, Olomouc, 77900, Czech Republic; +420 (0)585632860; lenka.stloukalova@upol.cz), ref: UPOL-3853/1030S-2025 |
| Health condition(s) or problem(s) studied | Functional temporomandibular pain syndrome |
| Intervention | Single-centre interventional prospective parallel-group randomized (1:1) controlled trial with concealed allocation, assessor blinding, and an active control (standard rehabilitation alone) comparing dry needling + standard rehabilitation versus standard rehabilitation alone. Experimental group: standard outpatient rehabilitation program combined with dry needling applied to trigger points in the masseter and temporalis muscles during the first treatment session. Control group: standard outpatient rehabilitation without dry needling. Each participant will undergo 10 outpatient sessions over 5 weeks (two per week). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Subjective pain intensity in the TMJ region assessed using the Visual Analogue Scale (0–10) at baseline, 24 hours, and 1 month after the start of therapy |
| Key secondary outcome measure(s) |
1. Quality of life is assessed using the WHOQOL questionnaire at baseline, 24 hours, and 1 month after the start of therapy |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | Adult patients with functional temporomandibular pain syndrome |
| Key exclusion criteria | 1. Structural TMJ disorders 2. Neurological disorders 3. Acute infection 4. Botulinum toxin application within the last 6 months |
| Date of first enrolment | 30/10/2025 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Faculty of Healthy Sciences
Hněvotínská 3
Olomouc
77900
Czech Republic
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. The datasets generated during and/or analysed during the current study will be available upon request from (petr Konecny, petr.konecny@upol.cz). Data will be collected only from participants who provide written informed consent approved by the ethics committee. Only anonymised summary data on treatment outcomes (pain, range of motion, quality of life) will be shared. The data will be available after study completion for a period of five years, upon written request for scientific purposes. Access will be granted only to qualified researchers after approval by the principal investigator. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/10/2025: Study's existence confirmed by the Ethics Committee of the Faculty of Health Sciences, Palacký University Olomouc.
