Temporomandibular DisorderNCT04086732
Assessment of Nociceptive Processing Among Patients With Temporo-mandibular Disorders
A study testing High-frequency electrical stimulation in people with Temporomandibular Disorder, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This case control study will investigate the physiological effect of nociceptive input in individuals with temporomandibular disorders. To do so, the investigators will compare the development of secondary hyperalgesia following high frequency electrical stimulation (HFS) of skin nociceptors in the forearms for up to… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- High-frequency electrical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Jan 2021to 29 Mar 2022
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged between 18 and 50 years.
- BMI between 17 and 30.
- Ability to provide written informed consent.
- Females aged between 18 and 50 years.
- BMI between 17 and 30.
- Ability to provide written informed consent.
- Chronic TMD (for at least 3 months) as a main complain (according to the DC/TMD), with an average of at least 3/10 on a pain numerical rating scale during the past month in the orofacial region.
Who cannot join
- Evidence of psychiatric/inflammatory/neurological or metabolic comorbidities on direct questioning as this study is meant to focus on musculoskeletal disorders.
- Evidence of skin alteration on the volar forearms that may interfere with HFS.
- Any substance abuse, or the use of antidepressant or neuroleptic medication as these may interfere with the psychophysical examination.
- Any painful musculoskeletal disorder.
- Lack of dental check-ups during the last 12 months.
- Evidence of psychiatric/inflammatory/neurological or metabolic comorbidities on direct questioning as this study is meant to focus on musculoskeletal disorders.
Show all 9Show fewer
- Evidence of skin alteration on the volar forearms that may interfere with HFS.
- Any substance abuse, or the use of antidepressant or neuroleptic medication as these may interfere with the psychophysical examination.
- Lack of dental check-ups during the last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Generalized Alterations in Nociceptive Processing Among Patients Presenting With Temporo-mandibular Disorders
This case control study will investigate the physiological effect of nociceptive input in individuals with temporomandibular disorders. To do so, the investigators will compare the development of secondary hyperalgesia following high frequency electrical stimulation (HFS) of skin nociceptors in the forearms for up to 48 hours in individuals with chronic TMD (as a main complain) and in healthy controls. Furthermore, the investigators will evaluate the association between the response to HFS and various factors, such as demographic, psychosocial and pain-related clinical factors.
Read the detailed description
This control study is designed to compare the development of secondary hyperalgesia following high frequency electrical stimulation (HFS) of skin nociceptors in the forearms in individuals with chronic TMD (as a main complain) and in healthy controls.
During the first part of the experiment (time1, day 1), all potential participants will fill a basic demographic questionnaire concerning their age, weight, height, and current medications (appendix 2). Participants with TMD will be diagnosed according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). The DC/TMD includes the following questionnaires: the Graded Chronic Pain Scale, the Jaw Functional Limitation scale, the Generalized Anxiety Disorder-7, the Patient Health Questionnaire-9 and -15 and the Oral Behaviors Checklist. In addition, participants will be asked to fill the Central sensitization inventory questionnaire, as well as the symptom Severity Scale. Lastly, the investigators will evaluate the distribution of pain by asking participants to draw the pain that they felt during the past 7 days on a digital tablet. This will allow us to determine the total area of pain of each participant, as well as the Widespread Pain Index. Subjects will also be asked to provide a rating of their average pain for the last 24h
The psychophysical evaluation will be conducted later on the same day (day1). Subjects will be asked to provide a rating of their average pain at present time (time 2). Then, participants will be familiarized with the different procedures involved in the experiment.
Pressure pain thresholds will be assessed on the temporalis muscle, the trapezius muscle, and tibialis anterior (time 3).
The intensity of pain resulting from pinprick stimulation and allodynia in the area surrounding the electrode ("test area") will be assessed, as well as on the homologous site of the contralateral control arm before HFS (time 4).
Then HFS will be applied (time 5) on the left or right volar forearm (10 cm distal to the cubital fossa). HFS will consist in trains of transcutaneous electrical stimuli consisting of 42 Hz trains (pulse width: 2 ms) lasting 1 s each. The trains will be repeated 12 times. Each train will be separated by several 10 seconds of rest. The intensity of each stimulus will be set to 5 milliampere.
The of pain resulting from pinprick stimulation and allodynia in the area surrounding the electrode ("test area") will be assessed 30 min after HFS (in a counterbalanced order) on the homologous site of the contralateral control arm (time 6).
The extent of secondary hyperalgesia will be assessed approximately 45 min following HFS (time 7).
Then, they will be asked assess the presence of secondary hyperalgesia in the test-site 24 (time 8, day 2) and 48 hours (time 9, day 3) following HFS with with calibrated neurological examination pins (Neuropen, Owen-Mumford Ltd, Oxford, UK).
6 months after their initial assessment (time 10, day 180), if they gave their consent for long-term follow-up, patients will be asked to fill the following questionnaires again
- Conditions
- Temporomandibular Disorder
- Being tested
- High-frequency electrical stimulation
- Keywords
- central sensitization, high-frequency stimulation
- 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.
High-frequency electrical stimulationProcedure or surgery
High-frequency stimulation will be applied on the volar forearm (6-10 cm distal to the cubital fossa). To avoid any confounding effect of handedness, the arm onto which HFS will be applied twice (dominant vs nondominant) will be counterbalanced across participants. HFS will consist of 12 trains of 42 Hz electrical pulses lasting 1 s each. The time interval between each train will be 10 s. The intensity of stimulation will be milliampere. Electrical pulses will be delivered to the skin using a specifically-designed electrode designed: the cathode consists of 16 blunt stainless-steel pins with a diameter of 0.2 mm protruding 1 mm from the base. The 16 pins are placed in a circle with a diameter of 10 mm. The anode consists of a surrounding stainless-steel ring having an inner diameter of 22 mm and an outer diameter of 40 mm. This procedure induces secondary pinprick hyperalgesia (an increase in pinprick sensitivity in a large area of the skin).
| Study group | Role | What they receive |
|---|---|---|
| Temporomandibular disorder | Experimental | Not described Receives: Procedure: High-frequency electrical stimulation |
| Healthy control | Experimental | Not described Receives: Procedure: High-frequency electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The extent of secondary hyperalgesia on the forearm in the proximo-distal direction 45 minutes after HFS
The area of secondary hyperalgesia (cm square) will be assessed with a calibrated 128 millinewton pinprick probe. Pokes of 1-second duration will be provided at a frequency of 0.5 Hz, starting well outside and approaching the stimulation site with steps of 0,5 cm from 4 different directions towards the application site. Participants will be asked to keep their eyes closed during the entire mapping procedure
Measured: After HFS and the assessment of pain resulting from pinprick stimulation and allodynia (time 7). This outcome is taken at day 1 at time 7.
Secondary outcomes (21)
Age
Self-declared age of the subject
Measured: During the initial evaluation (time 1). This outcome is taken at day 1 at time 1.
Weight
Self-declared weight of the subject
Measured: At baseline (time 1). This outcome is taken at day 1 at time 1.
Height
Self-declared height of the subject
Measured: At baseline (time 1). This outcome is taken at day 1 at time 1.
The TMD diagnosis according to the diagnostic criteria for temporomandibular disorders (DC/TMD)
TMD subgroup based on the DC/TMD: Myalgia, Arthralgia, Headache attributed to TMD, degenerative joint disease, disc displacement with reduction, disc displacement with reduction with intermittent locking, disc displacement with reduction with limited opening, disc displacement with reduction without limited opening, or subluxation.
Measured: At baseline (time 1). This outcome is taken at day 1 at time 1.
Graded chronic pain scale
questionnaire assessing TMD-related pain intensity and disability: The score will range from grade 0 (no TMD pain in prior 6 months) to grade IV (High disability, severly limiting)
Measured: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Jaw functional limitation scale
Questionnaire assessing limitations across mastication, jaw mobility, and verbal and emotional expression often accompanying TMD. The score will range from 0 (law functional limitation) to 10 (high functional limitation)
Measured: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Generalized anxiety disorder-7
Questionnaire assessing anxiety. The score will range from 0 (no anxiety) to 27 (severe anxiety)
Measured: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Patient health questionnaire-9
Questionnaire assessing depression symptoms. The score will range from 1 (minimal depression) to 27 (severe depression)
Measured: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Patient health questionnaire-15
Questionnaire assessing overall physical symptoms commonly associated with TMD. The score will range from 0 (minimal physical symptoms) to 30 (high physical symptoms)
Measured: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Oral Behaviors Checklist
Questionnaire assesses the frequency of oral parafunctional behaviors. The score will range from 0 (no oral parafunctional behaviors) to 84 (high oral parafunctional behavior frequency)
Measured: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Central sensitization inventory
Questionnaire assessing symptoms and comorbidities that are presumed to be associated with central sensitization. The score will range from 0 (no symptoms and comorbidities presumed to be associated with central sensitization) to 100 (extreme symptoms and comorbidities presumed to be associated with central sensitization).
Measured: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Symptom severity scale
Questionnaire assessing the severity of symptoms associated with fibromyalgia, a condition frequently associated with TMD. The score will range from 0 (low severity) to 12 (high severity).
Measured: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
The distribution of pain
Pain felt during the past 7 days drawn on a digital table
Measured: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
The Widespread pain index
Questionnaire assessing the extent of bodily pain. The score will range from 1 (no painful body region) to 19 (19 painful body regions)
Measured: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Average pain during the last 24h before HFS
Pain during the last 24h on a numerical rating scale. The score will range from 0 (no pain) to 100 (worst imaginable pain)
Measured: During the initial evaluation (time 1). This outcome is taken at day 1 at time 1.
Average pain at present time before HFS: score
Current pain on a numerical rating. The score will range from 0 (no pain) to 100 (worst imaginable pain)
Measured: During the initial evaluation (time 2). This outcome is taken at day 1 at time 2.
Pressure pain thresholds on the temporalis muscle, trapezius muscle and tibialis anterior
Pressure pain will be assessed 3 times on each muscle, with a 30-second interstimulus interval, and the arithmetic mean of the 3 repeated measures will be used for analysis
Measured: During the initial evaluation (time 3)]. This outcome is taken at day 1 at time 3.
Baseline pain resulting from pinprick stimulation in the area surrounding the electrode ("test area") and on the homologous site of the contralateral control arm
Participants will rate the pain induced by pin-prick stimulation in the area surrounding the electrode on a numerical rating scale ranging from 0 (no perception) to 100 (maximal pain), with 50 representing the transition from nonpainful to painful domains of sensation
Measured: Just before HFS (time 4)]. This outcome is taken at day 1 at time 4.
Allodynia in the area surrounding the electrode ("test area") and on the homologous site of the contralateral control arm
The investigators will assess allodynia with a Cotton wisp exerting a force of 3 millinewton, a cotton wool tip fixed to an elastic strip exerting a force of 100 millinewton when slightly bent, and a standardized brush exerting a force of 200-400 millinewton
Measured: Just before HFS (time 4) and after HFS (time 6). This outcome is taken at day 1 at time 4 and time 6.
The long term persistence of secondary hyperalgesia after HFS
Participants will assess the persistence of secondary hyperalgesia with calibrated neurological examination pins (Neuropen, Owen-Mumford Ltd, Oxford, UK). The score will range from 0 (no hyperalgesia) to 1 (hyperalgesia is present)
Measured: 24 hours (time 8) and 48 hours after HFS (time 9). This outcome is taken at day 2 at time 8, and at day 3 at time 9.
The intensity of pain resulting from pinprick stimulation 30 min after HFS
Participants will rate the pain induced by pin-prick stimulation in the area surrounding the electrode on a numerical rating scale ranging from 0 (no perception) to 100 (maximal pain), with 50 representing the transition from nonpainful to painful domains of sensation
Measured: Time Frame: At baseline (time 6). This outcome is taken at day 1 at time 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start11 Jan 2021
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086732
- Sponsor's protocol ID
- HFS Mandibular
- Status last verified
- Mar 2022
- First submitted
- 22 Aug 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Generalized Alterations in Nociceptive Processing Among Patients Presenting With Temporo-mandibular Disorders
- ClinicalTrials.gov ID
- NCT04086732
- Acronym / sponsor ID
- HFS Mandibular
- Conditions
- Temporomandibular Disorder
- Keywords
- central sensitization, high-frequency stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 12 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.
This case control study will investigate the physiological effect of nociceptive input in individuals with temporomandibular disorders. To do so, the investigators will compare the development of secondary hyperalgesia following high frequency electrical stimulation (HFS) of skin nociceptors in the forearms for up to 48 hours in individuals with chronic TMD (as a main complain) and in healthy controls. Furthermore, the investigators will evaluate the association between the response to HFS and various factors, such as demographic, psychosocial and pain-related clinical factors.
Detailed description
This control study is designed to compare the development of secondary hyperalgesia following high frequency electrical stimulation (HFS) of skin nociceptors in the forearms in individuals with chronic TMD (as a main complain) and in healthy controls.
During the first part of the experiment (time1, day 1), all potential participants will fill a basic demographic questionnaire concerning their age, weight, height, and current medications (appendix 2). Participants with TMD will be diagnosed according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). The DC/TMD includes the following questionnaires: the Graded Chronic Pain Scale, the Jaw Functional Limitation scale, the Generalized Anxiety Disorder-7, the Patient Health Questionnaire-9 and -15 and the Oral Behaviors Checklist. In addition, participants will be asked to fill the Central sensitization inventory questionnaire, as well as the symptom Severity Scale. Lastly, the investigators will evaluate the distribution of pain by asking participants to draw the pain that they felt during the past 7 days on a digital tablet. This will allow us to determine the total area of pain of each participant, as well as the Widespread Pain Index. Subjects will also be asked to provide a rating of their average pain for the last 24h
The psychophysical evaluation will be conducted later on the same day (day1). Subjects will be asked to provide a rating of their average pain at present time (time 2). Then, participants will be familiarized with the different procedures involved in the experiment.
Pressure pain thresholds will be assessed on the temporalis muscle, the trapezius muscle, and tibialis anterior (time 3).
The intensity of pain resulting from pinprick stimulation and allodynia in the area surrounding the electrode ("test area") will be assessed, as well as on the homologous site of the contralateral control arm before HFS (time 4).
Then HFS will be applied (time 5) on the left or right volar forearm (10 cm distal to the cubital fossa). HFS will consist in trains of transcutaneous electrical stimuli consisting of 42 Hz trains (pulse width: 2 ms) lasting 1 s each. The trains will be repeated 12 times. Each train will be separated by several 10 seconds of rest. The intensity of each stimulus will be set to 5 milliampere.
The of pain resulting from pinprick stimulation and allodynia in the area surrounding the electrode ("test area") will be assessed 30 min after HFS (in a counterbalanced order) on the homologous site of the contralateral control arm (time 6).
The extent of secondary hyperalgesia will be assessed approximately 45 min following HFS (time 7).
Then, they will be asked assess the presence of secondary hyperalgesia in the test-site 24 (time 8, day 2) and 48 hours (time 9, day 3) following HFS with with calibrated neurological examination pins (Neuropen, Owen-Mumford Ltd, Oxford, UK).
6 months after their initial assessment (time 10, day 180), if they gave their consent for long-term follow-up, patients will be asked to fill the following questionnaires again
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporomandibular disorder | Experimental | Procedure: High-frequency electrical stimulation |
| Healthy control | Experimental | Procedure: High-frequency electrical stimulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Females aged between 18 and 50 years.
- BMI between 17 and 30.
- Ability to provide written informed consent.
- Females aged between 18 and 50 years.
- BMI between 17 and 30.
Key exclusion criteria (9 listed)
- Evidence of psychiatric/inflammatory/neurological or metabolic comorbidities on direct questioning as this study is meant to focus on musculoskeletal disorders.
- Evidence of skin alteration on the volar forearms that may interfere with HFS.
- Any substance abuse, or the use of antidepressant or neuroleptic medication as these may interfere with the psychophysical examination.
- Any painful musculoskeletal disorder.
- Lack of dental check-ups during the last 12 months.
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 |
|---|---|---|
| High-frequency electrical stimulationHigh-frequency stimulation will be applied on the volar forearm (6-10 cm distal to the cubital fossa). To avoid any confounding effect of handedness, the arm onto which HFS will be applied twice (dominant vs nondominant) will be counterbalanced across participants. HFS will consist of 12 trains of 42 Hz electrical pulses lasting 1 s each. The time interval between each train will be 10 s. The intensity of stimulation will be milliampere. Electrical pulses will be delivered to the skin using a specifically-designed electrode designed: the cathode consists of 16 blunt stainless-steel pins with a diameter of 0.2 mm protruding 1 mm from the base. The 16 pins are placed in a circle with a diameter of 10 mm. The anode consists of a surrounding stainless-steel ring having an inner diameter of 22 mm and an outer diameter of 40 mm. This procedure induces secondary pinprick hyperalgesia (an increase in pinprick sensitivity in a large area of the skin). | Procedure or surgery | Healthy control, Temporomandibular disorder |
Primary outcome
The extent of secondary hyperalgesia on the forearm in the proximo-distal direction 45 minutes after HFS
Time frame: After HFS and the assessment of pain resulting from pinprick stimulation and allodynia (time 7). This outcome is taken at day 1 at time 7.
The area of secondary hyperalgesia (cm square) will be assessed with a calibrated 128 millinewton pinprick probe. Pokes of 1-second duration will be provided at a frequency of 0.5 Hz, starting well outside and approaching the stimulation site with steps of 0,5 cm from 4 different directions towards the application site. Participants will be asked to keep their eyes closed during the entire mapping procedure
21 secondary outcomes
Age
Time frame: During the initial evaluation (time 1). This outcome is taken at day 1 at time 1.
Weight
Time frame: At baseline (time 1). This outcome is taken at day 1 at time 1.
Height
Time frame: At baseline (time 1). This outcome is taken at day 1 at time 1.
The TMD diagnosis according to the diagnostic criteria for temporomandibular disorders (DC/TMD)
Time frame: At baseline (time 1). This outcome is taken at day 1 at time 1.
Graded chronic pain scale
Time frame: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Jaw functional limitation scale
Time frame: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Generalized anxiety disorder-7
Time frame: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Patient health questionnaire-9
Time frame: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Patient health questionnaire-15
Time frame: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Oral Behaviors Checklist
Time frame: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Central sensitization inventory
Time frame: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Symptom severity scale
Time frame: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
The distribution of pain
Time frame: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
The Widespread pain index
Time frame: At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.
Average pain during the last 24h before HFS
Time frame: During the initial evaluation (time 1). This outcome is taken at day 1 at time 1.
Average pain at present time before HFS: score
Time frame: During the initial evaluation (time 2). This outcome is taken at day 1 at time 2.
Pressure pain thresholds on the temporalis muscle, trapezius muscle and tibialis anterior
Time frame: During the initial evaluation (time 3)]. This outcome is taken at day 1 at time 3.
Baseline pain resulting from pinprick stimulation in the area surrounding the electrode ("test area") and on the homologous site of the contralateral control arm
Time frame: Just before HFS (time 4)]. This outcome is taken at day 1 at time 4.
Allodynia in the area surrounding the electrode ("test area") and on the homologous site of the contralateral control arm
Time frame: Just before HFS (time 4) and after HFS (time 6). This outcome is taken at day 1 at time 4 and time 6.
The long term persistence of secondary hyperalgesia after HFS
Time frame: 24 hours (time 8) and 48 hours after HFS (time 9). This outcome is taken at day 2 at time 8, and at day 3 at time 9.
The intensity of pain resulting from pinprick stimulation 30 min after HFS
Time frame: Time Frame: At baseline (time 6). This outcome is taken at day 1 at time 6.
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 7 Apr 2022.
- 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.
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 High-frequency electrical stimulation in people with Temporomandibular Disorder, run by Université Catholique de Louvain at 1 site in Belgium.
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 7 inclusion and 9 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 7 Apr 2022. 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 Belgium. 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?
The extent of secondary hyperalgesia on the forearm in the proximo-distal direction 45 minutes after HFS (time frame: After HFS and the assessment of pain resulting from pinprick stimulation and allodynia (time 7). This outcome is taken at day 1 at time 7.). 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 7 Apr 2022.