PainNCT05021874
The Effect of Different Physiotherapeutic Stimuli on Stomatognathic System Structures.
A study testing Four different physiotherapy treatment in people with Pain and Stomatognathic Diseases, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
The study will determinate influence of four selected physiotherapeutic procedures on the pain intensity and the range of mandibular mobility in patients with myofascial disorders in the SS. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Stomatognathic Diseases, Muscle Hypertonia
- What is being tested?
- Four different physiotherapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2021to 30 Oct 2021
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Myofacial pain of less than 12 months in duration that is evoked by an active motion of the mandible or by palpation.
- Diagnosis according to RDC / TMD (Research Diagnostic Criteria for Temporomandibular Disorders), which showed painful myofascial disorders III. A feeling of an increased muscle tension IV. Presence of all occlusal contact zones V. Female sex
Who cannot join
- Past or present, neurological disease, neuromuscular disease or a severe systemic disease.
- Temporomandibular joint pathology based on X-ray imaging or stomatological examination.
- Orthodontic or prosthetic treatment IV. Contraindication to physiotherapeutic treatment
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Musculoskeletal System Rehabilitation, Pomeraniam Medical University
Szczecin
About this study
Official title: The Effect of Different Physiotherapeutic Stimuli on Mandibular Analgesia and Range of Motion in Patients With Masticatory Muscles Disorder.
The study will determinate influence of four selected physiotherapeutic procedures on the pain intensity and the range of mandibular mobility in patients with myofascial disorders in the SS.
Read the detailed description
The study group will consist of 100 women (GI) aged 20 to 45 who report pain and increased facial muscle tension in masseter muscles.
The diagnosis will be made according to RDC/TMD (Research Diagnostic Criteria for Temporomandibular Disorders), which will determine the occurrence of painful myofascial disorders. Patients will undergo both external and intraoral dental examinations to exclude odontogenic and articular causes of pain. Patients will then be palpated for the masseter muscles and both: the range of mandibular abduction (linear measurement in mm) and the level of pain intensity (VAS scale).
The control group (GII) will consist of 100 women between 20 and 45 years of age with no signs of masticatory disorders or orofacial pain during a physical examination and with no such reference in their medical records.
In order to obtain a homogenic study group the following inclusion criteria will be applied:
- Myofascial pain of less than 12 months in duration that is evoked by an active motion of the mandible or by palpation.
- A feeling of an increased muscle tension
- Presence of all occlusal contact zones
- Female sex
Exclusion criteria:
- Past or present, neurological disease, neuromuscular disease or severe systemic disease.
- Temporomandibular joint pathology based on X-ray imaging or stomatological examination.
- Orthodontic or prosthetic treatment
- Contraindication to physiotherapeutic treatment
Patients with a stomatognathic system disorder will be randomized into four therapeutic subgroups, 26 patients each, who will receive a physiotherapy treatment of the masseter muscles for a period of 10 days (excluding Saturdays and Sundays). The duration of a single therapy session will be 12 minutes per patient in each of the subgroups.
The division of the study group into subgroups is as follows:
- IA: magnetotherapy; a pulsating, non-homogeneous magnetic field generated by the Viofor JPS apparatus (Med \& Life, Poland) will be applied with an elliptical applicator with a beamwidth of approx. 5 cm.
- IB: magneto-led therapy; synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med \& Life, Poland) and LED diodes with the wavelength of 860 nm will be applied with an elliptic magnetic-light (IR) applicator with a diameter of 5 [cm] containing 47 infrared diodes.
- IC: magneto-laser therapy; synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med \& Life, Poland) and a low-energy laser with an infrared wavelength of 808 [nm] (max. power 300 mW) will be applied. The dose would increase from 3,0 J/cm2 to 5,0 J/cm2 and the total dose applied per each patient from this subgroup was 40 J/cm2.
- ID: manual therapy of soft tissues (i.e. post-isometric relaxation of the masseter, cellular and tissue mobilization with Kibler fold, masseter trigger point therapy).
Immediately after the therapy, the patients' pain level will be assessed via VAS scale. After the last day of physiotherapy, a linear measurement of mandibular abduction will be performed.
- Conditions
- Pain, Stomatognathic Diseases, Muscle Hypertonia, Myofacial Pain Syndromes, Analgesia, Musculoskeletal Pain
- Being tested
- Four different physiotherapy treatment
- Keywords
- Pain, Physiotherapy, Range of motion, Temporomandibular Joint, Stomatognathic system
- Medical subject headings
- Pain, Stomatognathic Diseases, Muscle Hypertonia, Facial Neuralgia, Agnosia, Musculoskeletal Pain, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four different physiotherapy treatmentOther
Four different physiotherapy treatment will be used for, to reduce pain and tension in the masseter muscles. The assessment of pain intensity on the VAS scale will be assessed each time after the therapy. After the 10th day of therapy, it will be measured ROM.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapeutic procedures: magnetotherapy | Active comparator | Magnetotherapy is a pulsating, non-homogeneous magnetic field generated by the Viofor JPS apparatus (Med \& Life, Poland) will be applied using an elliptical applicator with a beam width of approx. 5 cm. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days. Receives: Other: Four different physiotherapy treatment |
| Physiotherapeutic procedures:magneto-led therapy | Active comparator | Magneto-led therapy is a synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med \& Life, Poland) and LED diodes with the wavelength of 860 nm were applied using an elliptic magnetic-light (IR) applicator with a diameter of 5 [cm] containing 47 infrared diodes. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days. Receives: Other: Four different physiotherapy treatment |
| Physiotherapeutic procedures:magneto-laser therapy | Active comparator | Magneto-laser therapy is a synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med \& Life, Poland) and a low-energy laser with infrared wavelength of 808 [nm] (max. power 300 mW) was applied. The dose was set to increase from 3,0 J/cm2 to 5,0 J/cm2 and the total dose applied per each patient from this subgroup was 40 J/cm2. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days. Receives: Other: Four different physiotherapy treatment |
| Physiotherapeutic procedures: manual therapy of soft tissues | Active comparator | Manual therapy of soft tissues will include: post-isometric relaxation of the masseter, cellular and tissue mobilization with Kibler fold, masseter trigger point therapy. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days. Receives: Other: Four different physiotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Measurement on Visual Analogue Scale (VAS). It consists of a line, approximately 100 mm in length, at the left end of the scale "Score 0" witch means "no pain", at the right end of scale "Score 100mm" witch means "worst imaginable pain" [Time Frame: 10 days]
Measured: 10 days
Measurement of the range of motion
Measurement of the range of mobility of the maximum abduction of the mandible (linear measurement from in mm. the upper to the lower incisor).
[Time Frame: 10 days]
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion25 Sep 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalewski Bartosz, Pomeranian Medical University Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021874
- Sponsor's protocol ID
- KB - 0012/102/13
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gebska M, Dalewski B, Palka L, Kiczmer P, Kolodziej L. Kinesio Taping as an alternative therapy for limited mandibular mobility with pain in female patients with temporomandibular disorders: A randomized controlled trial. Dent Med Probl. 2024 Sep-Oct;61(5):659-670. doi: 10.17219/dmp/173126.
PubMed 38832764
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Physiotherapeutic Stimuli on Mandibular Analgesia and Range of Motion in Patients With Masticatory Muscles Disorder.
- ClinicalTrials.gov ID
- NCT05021874
- Acronym / sponsor ID
- KB - 0012/102/13
- Conditions
- Pain, Stomatognathic Diseases, Muscle Hypertonia, Myofacial Pain Syndromes, Analgesia, Musculoskeletal Pain
- Keywords
- Pain, Physiotherapy, Range of motion, Temporomandibular Joint, Stomatognathic system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 25 Sep 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 26 Aug 2021 (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.
The study will determinate influence of four selected physiotherapeutic procedures on the pain intensity and the range of mandibular mobility in patients with myofascial disorders in the SS.
Detailed description
The study group will consist of 100 women (GI) aged 20 to 45 who report pain and increased facial muscle tension in masseter muscles.
The diagnosis will be made according to RDC/TMD (Research Diagnostic Criteria for Temporomandibular Disorders), which will determine the occurrence of painful myofascial disorders. Patients will undergo both external and intraoral dental examinations to exclude odontogenic and articular causes of pain. Patients will then be palpated for the masseter muscles and both: the range of mandibular abduction (linear measurement in mm) and the level of pain intensity (VAS scale).
The control group (GII) will consist of 100 women between 20 and 45 years of age with no signs of masticatory disorders or orofacial pain during a physical examination and with no such reference in their medical records.
In order to obtain a homogenic study group the following inclusion criteria will be applied:
- Myofascial pain of less than 12 months in duration that is evoked by an active motion of the mandible or by palpation.
- A feeling of an increased muscle tension
- Presence of all occlusal contact zones
- Female sex
Exclusion criteria:
- Past or present, neurological disease, neuromuscular disease or severe systemic disease.
- Temporomandibular joint pathology based on X-ray imaging or stomatological examination.
- Orthodontic or prosthetic treatment
- Contraindication to physiotherapeutic treatment
Patients with a stomatognathic system disorder will be randomized into four therapeutic subgroups, 26 patients each, who will receive a physiotherapy treatment of the masseter muscles for a period of 10 days (excluding Saturdays and Sundays). The duration of a single therapy session will be 12 minutes per patient in each of the subgroups.
The division of the study group into subgroups is as follows:
- IA: magnetotherapy; a pulsating, non-homogeneous magnetic field generated by the Viofor JPS apparatus (Med \& Life, Poland) will be applied with an elliptical applicator with a beamwidth of approx. 5 cm.
- IB: magneto-led therapy; synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med \& Life, Poland) and LED diodes with the wavelength of 860 nm will be applied with an elliptic magnetic-light (IR) applicator with a diameter of 5 [cm] containing 47 infrared diodes.
- IC: magneto-laser therapy; synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med \& Life, Poland) and a low-energy laser with an infrared wavelength of 808 [nm] (max. power 300 mW) will be applied. The dose would increase from 3,0 J/cm2 to 5,0 J/cm2 and the total dose applied per each patient from this subgroup was 40 J/cm2.
- ID: manual therapy of soft tissues (i.e. post-isometric relaxation of the masseter, cellular and tissue mobilization with Kibler fold, masseter trigger point therapy).
Immediately after the therapy, the patients' pain level will be assessed via VAS scale. After the last day of physiotherapy, a linear measurement of mandibular abduction will be performed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physiotherapeutic procedures: magnetotherapy | Active comparator | Other: Four different physiotherapy treatmentMagnetotherapy is a pulsating, non-homogeneous magnetic field generated by the Viofor JPS apparatus (Med \& Life, Poland) will be applied using an elliptical applicator with a beam width of approx. 5 cm. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days. |
| Physiotherapeutic procedures:magneto-led therapy | Active comparator | Other: Four different physiotherapy treatmentMagneto-led therapy is a synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med \& Life, Poland) and LED diodes with the wavelength of 860 nm were applied using an elliptic magnetic-light (IR) applicator with a diameter of 5 [cm] containing 47 infrared diodes. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days. |
| Physiotherapeutic procedures:magneto-laser therapy | Active comparator | Other: Four different physiotherapy treatmentMagneto-laser therapy is a synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med \& Life, Poland) and a low-energy laser with infrared wavelength of 808 [nm] (max. power 300 mW) was applied. The dose was set to increase from 3,0 J/cm2 to 5,0 J/cm2 and the total dose applied per each patient from this subgroup was 40 J/cm2. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days. |
| Physiotherapeutic procedures: manual therapy of soft tissues | Active comparator | Other: Four different physiotherapy treatmentManual therapy of soft tissues will include: post-isometric relaxation of the masseter, cellular and tissue mobilization with Kibler fold, masseter trigger point therapy. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Myofacial pain of less than 12 months in duration that is evoked by an active motion of the mandible or by palpation.
- Diagnosis according to RDC / TMD (Research Diagnostic Criteria for Temporomandibular Disorders), which showed painful myofascial disorders III. A feeling of an increased muscle tension IV. Presence of all occlusal contact zones V. Female sex
Key exclusion criteria (3 listed)
- Past or present, neurological disease, neuromuscular disease or a severe systemic disease.
- Temporomandibular joint pathology based on X-ray imaging or stomatological examination.
- Orthodontic or prosthetic treatment IV. Contraindication to physiotherapeutic 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 |
|---|---|---|
| Four different physiotherapy treatmentFour different physiotherapy treatment will be used for, to reduce pain and tension in the masseter muscles. The assessment of pain intensity on the VAS scale will be assessed each time after the therapy. After the 10th day of therapy, it will be measured ROM. | Other | Physiotherapeutic procedures: magnetotherapy, Physiotherapeutic procedures: manual therapy of soft tissues, Physiotherapeutic procedures:magneto-laser therapy, Physiotherapeutic procedures:magneto-led therapy |
Primary outcome
Pain relief
Time frame: 10 days
Measurement on Visual Analogue Scale (VAS). It consists of a line, approximately 100 mm in length, at the left end of the scale "Score 0" witch means "no pain", at the right end of scale "Score 100mm" witch means "worst imaginable pain" [Time Frame: 10 days]
Measurement of the range of motion
Time frame: 10 days
Measurement of the range of mobility of the maximum abduction of the mandible (linear measurement from in mm. the upper to the lower incisor). [Time Frame: 10 days]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Derived from this study: PubMed 38832764Gebska M, Dalewski B, Palka L, Kiczmer P, Kolodziej L. Kinesio Taping as an alternative therapy for limited mandibular mobility with pain in female patients with temporomandibular disorders: A randomized controlled trial. Dent Med Probl. 2024 Sep-Oct;61(5):659-670. doi: 10.17219/dmp/173126.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four different physiotherapy treatment in people with Pain and Stomatognathic Diseases, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Aug 2021. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magdalena Gębska, PhD (91 441 72 53 ext. +48, mgebska@pum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 10 days). The study lists 2 primary outcomes in all. 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 NCT05021874, which also lists 1 linked publication.
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 26 Aug 2021.