Temporomandibular DisordersNCT04098952
Effects of Electric Massage on the Cervical Region in Subjects Diagnosed With Temporomandibular Disorders
A study testing Group 1: Manual Therapy and Group 2: Interferential massage plus Manual Therapy in people with Temporomandibular Disorders, run by Luis Espejo Antúnez PhD at 1 site in Spain.
Trial summary
To know the short-term effects of electric massage applied on the cervical region combined with local techniques on the temporomandibular joint versus an intervention that applies only local techniques in subjects diagnosed with temporomandibular disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- Group 1: Manual Therapy and Group 2: Interferential massage plus Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 18 Nov 2019to 14 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent of the subject to participate in the study.
- A primary diagnosis of myofascial pain according to Axis I, category Ia and Ib (i.e. myofascial pain with or without limited opening) of the Research Diagnostic Criteria for TMD (RDC ⁄ TMD) (Schiffman E, Ohrbach R, Truelove E, et al. Diagnostic criteria for tempormandibular disorders (DC(TMD) for clinical and research applications: recommendations of the International RDC/TMD consortium network* and orofacial pain special interest group. J Oral facial pain headache. 2014;28(1):6-27").
- Bilateral pain involving the masseter and temporal regions; presence of at least one trigger point (TrP) in the masseter muscle.
- Pain symptoms history of at least the 3 months previous to the study.
- Intensity of the pain of at least 30 mm on a 100 mm Visual Analogue Scale (VAS).
- A score of less than 45 points on the Personal Psychological Apprehension Scale (PPAS). It has been validated in the scope of physiotherapy, and represents a simple-to-handle tool in studies where subjects may undergo electrotherapy as a treatment option.
Who cannot join
- Surgical intervention of the temporomandibular joints (TMJ).
- Suffering some intra-articular damage (arthritis) or some vestibular disorder diagnosed.
- Inflammation of the TMJ.
- Having received physiotherapy treatment in the last two weeks.
- Receive pharmacological treatment for analgesic, anti-inflammatory or that could cause alterations of equilibrium.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Electric Massage on the Cervical Region Combined With Local Techniques on the Temporomandibular Joint Versus an Intervention Only With Local Techniques in Subjects Diagnosed With Temporomandibular Disorders
To know the short-term effects of electric massage applied on the cervical region combined with local techniques on the temporomandibular joint versus an intervention that applies only local techniques in subjects diagnosed with temporomandibular disorders.
Read the detailed description
This study aims to know the short-term effects of electric massage applied to the cervical region combined with local techniques on the temporomandibular pain versus an intervention that applies only local techniques in subjects diagnosed with temporomandibular disorders. This is a prospective, controlled, single-blind clinical trial of 46 subjects randomly divided into two groups: Group 1 Manual Therapy=21; Group 2 Interferential massage plus Manual Therapy=25. Group 1 will receive manual therapy consisting of techniques of ischemic compression on masseter muscles and soft-tissue release technique over the temporal región. Group 2, in addition to the intervention in group 1, will receive electric massage with interferential currents at the cervical level.
Pain related measures (Visual Analogue Scale oral, Pressure Pain Threshold (PPT)), vertical mouth opening as primary outcome measures and cervical range of motion as secondary outcomes were assessed. The assessments were made before the intervention, immediately after and after 4 weeks of follow-up.
- Conditions
- Temporomandibular Disorders
- Being tested
- Group 1: Manual Therapy, Group 2: Interferential massage plus Manual Therapy
- Keywords
- temporomandibular disorders, electric massage, temporomandibular joint, local techniques
- 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.
Group 1: Manual TherapyOther
The treatment techniques used will be: ischemic compression in the trigger point of the masseter and soft-tissue release technique over the temporal region.
Group 2: Interferential massage plus Manual TherapyOther
In addition to the treatment techniques applied to the other group, an electric massage will be performed with interferential currents at the level of the cervical region.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Manual Therapy | Active comparator | The treatment techniques used will be: ischemic compression in the trigger point of the masseter and soft-tissue release technique over the temporal region. Receives: Other: Group 1: Manual Therapy |
| Group 2: Interferential massage plus Manual Therapy | Experimental | In addition to the treatment techniques applied to the other group, an electric massage will be performed with interferential currents at the level of the cervical region. Receives: Other: Group 2: Interferential massage plus Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the assessment of the maximum amplitude of the vertical opening of the mouth:
The maximum vertical opening of the mouth was measured using a manual gauge. The measurements were taken with the subjects placed in the supine position on the stretcher, with the head resting on it, the cervical spine in a neutral position, knees slightly bent and the upper limbs extended along the body.
In this position, we ask participants to open their mouths as much as possible without causing pain. In this way, we obtain the measurement in millimeters the distance between the upper and lower central incisors.
Measured: Immediately after the intervention as well as 4 weeks after the intervention.
Changes in the assessment of pain intensity: VAS
To measure pain, the visual analog scale (VAS) has been used. The VAS scale is an instrument used very often to quantify the intensity of pain. The accuracy and validity of the EVA scale as a measure of pain has been demonstrated previously.
Participants were asked to indicate the degree of pain intensity in response to manual palpation of the central trigger point of the masseter bilaterally using a 10 cm analogue visual scale where 0 corresponds to "no pain" and 10 to "worst pain" that you can imagine. " When performing the post-treatment assessment, a period of 1 minute of rest was left to prevent the change of position from influencing the data obtained, especially in the displacements of the pressure center.
Measured: Immediately after the intervention as well as 4 weeks after the intervention.
Changes in the valuation of pain threshold to pressure.
To measure the pain threshold to the pressure in muscle trigger points, a manual algometer with 1 cm2 of contact area was used. The algometer serves to record the minimum amount of pressure needed for the sensation of pressure to change to a sensation of pain. When this moment arrives, the subject will say "already" and the algometer immediately withdrawn, the pressure being recorded. The results obtained will be expressed in kg / cm2 (1,8).
The muscles assessed were masseter and superior trapezius, both bilaterally in the supine position. The pressure in both must be done in a direction perpendicular to the muscle fibers. In the case of the upper trapezius, the algometer will be placed on the trigger point 1 described by Travell and Simons (9). In the masseter, the pressure perpendicular to the algometer will be applied on the central trigger point of the superficial portion of said muscle as described by Travell.
Measured: Immediately after the intervention as well as 4 weeks after the intervention.
Secondary outcomes (1)
Changes in the assessment of cervical range of motion.
The goniometry is used to evaluate the range of joint movement. The range of cervical movement can be evaluated with many instruments, but the goniometer offers a simple and low cost alternative for evaluation.
In this case, for the measurement of the range of cervical movement we will use a universal goniometer that presents a scale of measurement in degrees. The patient will be placed in a sitting position in a chair and we will give him the order to perform the movement to be evaluated. The movements to be evaluated will be right and left rotation, flexion, extension and right and left side bending. We will prevent the patient from making compensations with other body regions.
Measured: Immediately after the intervention as well as 4 weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start18 Nov 2019
- Primary completion18 Nov 2019
- Study completion14 Oct 2021
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 Temporomandibular 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luis Espejo Antúnez PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luis Espejo Antúnez PhD, Universidad de Extremadura
- Investigators
- Luis Espejo Antúnez, PhD, Study director, Department of Medical Surgical Therapy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098952
- Sponsor's protocol ID
- LE0001
- Status last verified
- Nov 2021
- First submitted
- 10 Jun 2019
- Last updated
- 9 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Espejo-Antunez L, Cardero-Duran MLA, Heredia-Rizo AM, Casuso-Holgado MJ, Albornoz-Cabello M. Effects of adding electro-massage to manual therapy for the treatment of individuals with myofascial temporomandibular pain: a randomized controlled trial. J Appl Oral Sci. 2024 Sep 16;32:e20240109. doi: 10.1590/1678-7757-2024-0109. eCollection 2024.
PubMed 39292112
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electric Massage on the Cervical Region Combined With Local Techniques on the Temporomandibular Joint Versus an Intervention Only With Local Techniques in Subjects Diagnosed With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT04098952
- Acronym / sponsor ID
- LE0001
- Conditions
- Temporomandibular Disorders
- Keywords
- temporomandibular disorders, electric massage, temporomandibular joint, local techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Luis Espejo Antúnez PhDUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 23 Sep 2019 (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.
To know the short-term effects of electric massage applied on the cervical region combined with local techniques on the temporomandibular joint versus an intervention that applies only local techniques in subjects diagnosed with temporomandibular disorders.
Detailed description
This study aims to know the short-term effects of electric massage applied to the cervical region combined with local techniques on the temporomandibular pain versus an intervention that applies only local techniques in subjects diagnosed with temporomandibular disorders. This is a prospective, controlled, single-blind clinical trial of 46 subjects randomly divided into two groups: Group 1 Manual Therapy=21; Group 2 Interferential massage plus Manual Therapy=25. Group 1 will receive manual therapy consisting of techniques of ischemic compression on masseter muscles and soft-tissue release technique over the temporal región. Group 2, in addition to the intervention in group 1, will receive electric massage with interferential currents at the cervical level.
Pain related measures (Visual Analogue Scale oral, Pressure Pain Threshold (PPT)), vertical mouth opening as primary outcome measures and cervical range of motion as secondary outcomes were assessed. The assessments were made before the intervention, immediately after and after 4 weeks of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Manual Therapy | Active comparator | Other: Group 1: Manual TherapyThe treatment techniques used will be: ischemic compression in the trigger point of the masseter and soft-tissue release technique over the temporal region. |
| Group 2: Interferential massage plus Manual Therapy | Experimental | Other: Group 2: Interferential massage plus Manual TherapyIn addition to the treatment techniques applied to the other group, an electric massage will be performed with interferential currents at the level of the cervical region. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Consent of the subject to participate in the study.
- A primary diagnosis of myofascial pain according to Axis I, category Ia and Ib (i.e. myofascial pain with or without limited opening) of the Research Diagnostic Criteria for TMD (RDC ⁄ TMD) (Schiffman E, Ohrbach R, Truelove E, et al. Diagnostic criteria for tempormandibular disorders (DC(TMD) for clinical and research applications: recommendations of the International RDC/TMD consortium network* and orofacial pain special interest group. J Oral facial pain headache. 2014;28(1):6-27").
- Bilateral pain involving the masseter and temporal regions; presence of at least one trigger point (TrP) in the masseter muscle.
- Pain symptoms history of at least the 3 months previous to the study.
- Intensity of the pain of at least 30 mm on a 100 mm Visual Analogue Scale (VAS).
Key exclusion criteria (5 listed)
- Surgical intervention of the temporomandibular joints (TMJ).
- Suffering some intra-articular damage (arthritis) or some vestibular disorder diagnosed.
- Inflammation of the TMJ.
- Having received physiotherapy treatment in the last two weeks.
- Receive pharmacological treatment for analgesic, anti-inflammatory or that could cause alterations of equilibrium.
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 |
|---|---|---|
| Group 1: Manual TherapyThe treatment techniques used will be: ischemic compression in the trigger point of the masseter and soft-tissue release technique over the temporal region. | Other | Group 1: Manual Therapy |
| Group 2: Interferential massage plus Manual TherapyIn addition to the treatment techniques applied to the other group, an electric massage will be performed with interferential currents at the level of the cervical region. | Other | Group 2: Interferential massage plus Manual Therapy |
Primary outcome
Changes in the assessment of the maximum amplitude of the vertical opening of the mouth:
Time frame: Immediately after the intervention as well as 4 weeks after the intervention.
The maximum vertical opening of the mouth was measured using a manual gauge. The measurements were taken with the subjects placed in the supine position on the stretcher, with the head resting on it, the cervical spine in a neutral position, knees slightly bent and the upper limbs extended along the body. In this position, we ask participants to open their mouths as much as possible without causing pain. In this way, we obtain the measurement in millimeters the distance between the upper and lower central incisors.
Changes in the assessment of pain intensity: VAS
Time frame: Immediately after the intervention as well as 4 weeks after the intervention.
To measure pain, the visual analog scale (VAS) has been used. The VAS scale is an instrument used very often to quantify the intensity of pain. The accuracy and validity of the EVA scale as a measure of pain has been demonstrated previously. Participants were asked to indicate the degree of pain intensity in response to manual palpation of the central trigger point of the masseter bilaterally using a 10 cm analogue visual scale where 0 corresponds to "no pain" and 10 to "worst pain" that you can imagine. " When performing the post-treatment assessment, a period of 1 minute of rest was left to prevent the change of position from influencing the data obtained, especially in the displacements of the pressure center.
Changes in the valuation of pain threshold to pressure.
Time frame: Immediately after the intervention as well as 4 weeks after the intervention.
To measure the pain threshold to the pressure in muscle trigger points, a manual algometer with 1 cm2 of contact area was used. The algometer serves to record the minimum amount of pressure needed for the sensation of pressure to change to a sensation of pain. When this moment arrives, the subject will say "already" and the algometer immediately withdrawn, the pressure being recorded. The results obtained will be expressed in kg / cm2 (1,8). The muscles assessed were masseter and superior trapezius, both bilaterally in the supine position. The pressure in both must be done in a direction perpendicular to the muscle fibers. In the case of the upper trapezius, the algometer will be placed on the trigger point 1 described by Travell and Simons (9). In the masseter, the pressure perpendicular to the algometer will be applied on the central trigger point of the superficial portion of said muscle as described by Travell.
1 secondary outcome
Changes in the assessment of cervical range of motion.
Time frame: Immediately after the intervention as well as 4 weeks after the intervention.
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 9 Nov 2021.
- Derived from this study: PubMed 39292112Espejo-Antunez L, Cardero-Duran MLA, Heredia-Rizo AM, Casuso-Holgado MJ, Albornoz-Cabello M. Effects of adding electro-massage to manual therapy for the treatment of individuals with myofascial temporomandibular pain: a randomized controlled trial. J Appl Oral Sci. 2024 Sep 16;32:e20240109. doi: 10.1590/1678-7757-2024-0109. eCollection 2024.
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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.
Luis Espejo Antúnez, PhD study director
Department of Medical Surgical Therapy.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: Manual Therapy and Group 2: Interferential massage plus Manual Therapy in people with Temporomandibular Disorders, run by Luis Espejo Antúnez PhD at 1 site in Spain.
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 5 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 9 Nov 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 Spain. 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?
Changes in the assessment of the maximum amplitude of the vertical opening of the mouth: (time frame: Immediately after the intervention as well as 4 weeks after the intervention.). The study lists 3 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 NCT04098952, 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 9 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.