Orofacial PainPhase 2NCT01883245
Effects of Transcranial Direct Current Stimulation (tDCS) on Patients With Chronic Orofacial Pain
A Phase 2 study testing real tDCS in people with Orofacial Pain, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
Patients affected by chronic orofacial pain represent an emergent medical problem due to the lack of knowledge on the cause, pathophysiology and psychology of many of these conditions, that belongs to a multifactorial origin. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Orofacial Pain
- What is being tested?
- real tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Feb 2014
- Phase
- Phase 2
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female between 18 and 75 years old
- Clinic history of previous orofacial and/or dental surgery
- Chronic orofacial pain for more than a year measurable by the VAS more than 3 .
- Pain not responsive to pharmacological treatment (analgesic, anti inflammatory, opiates, antidepressant drugs and physiotherapy modalities)
Who cannot join
- Contraindication to tDCS: presence of metallic implants that can be stimulated, moved or overheated by electric current, positive anamnesis for epilepsy, implantable systems ( ventriculoperitoneal shunt, pacemaker, intracranial pumps, intracranial metallic systems)
- Major neurological or psychiatric pathologies
- Pregnancy
- Severe hepatorenal and cardiopulmonary diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) in Patients With Chronic Orofacial Pain Unresponsive to Conventional Treatment. A Randomized Controlled Trial.
Patients affected by chronic orofacial pain represent an emergent medical problem due to the lack of knowledge on the cause, pathophysiology and psychology of many of these conditions, that belongs to a multifactorial origin.
Particularly, temporomandibular joint disorders involve a series of symptoms that refers both to intrinsic and extrinsic joint conditions where pain can be associated to a reduction of the joint movement, click or to other sounds of the joint.
Read more
The lack of a recognized causal therapy led to the suggestion of many treatment modalities with a multidisciplinary approach for the management of symptoms that include the use of occlusal splints, physiotherapy-speech therapy, behavioral and physical therapy, drugs, chirurgical approaches. In most cases these strategies together allow the control of the symptoms, even though they aren't completely resolutive.
In these patients is frequent chronic pain and ineffectiveness of common drugs used.
It has been demonstrated how transcranial electrical brain stimulation with direct current (tDCS) is able to reduce the intensity and the duration of chronic pain.
Stimulating the motor cortex can reduce pain by modulating brain activities in the areas involved in cerebral circuits controlling pain, such as thalamus, facilitating the descendant inhibitory mechanisms and enhancing the number of opiates receptors.
This clinical trial is based on the evaluation of the effects of tDCS on pain and on activities daily living (ADL) participation patients with chronic orofacial pain that don't respond to other treatments.
Read the detailed description
Inclusion criteria:
- Male and female between 18 and 75 years old
- Clinic history of previous orofacial and/or dental surgery
- Chronic orofacial pain for more than a year measurable by the VAS more than 3 .
- Pain not responsive to pharmacological treatment (analgesic, anti inflammatory, opiaces, antidepressant drugs and physiotherapy modalities)
Outcome measures:
Subjects will be assessed before the beginning of the treatment (T0), after tDCS (T1) and after one month of stimulation(T2) .
In the two weeks prior to T0 the patient will be asked in a questionnaire to report daily the level of pain, anxiety and state of mind using the VAS. This period of observation is necessary for the patient to get used to these measures and to underline possible intra-subject changing.
- Clinic scales
-Visual Analogue Scale (VAS): it is one of the most used between scales for pain evaluation [18]
RDC/TMD AXIS I: diagnostic classification for temporomandibolar disfunction. RDC/TMD AXIS II: behavioral questionnaire (7 questions about chronic pain severity) which evaluates chronic pain following the graded scale for chronic pain.
- Symptoms Checklist-90-R scales (SCL 90-R): Depression and anxiety assessment for non-specific physical symptoms
- electrical pain threshold: The Digitimer High Voltage Stimulator model DS74 provides high voltage pulses of constant current up to 100mA, pulses are of short duration and the output current is variable ranging between 0 and 100mA. The Digitimer is used to evaluate the pain perception threshold by applying electrical stimulation to the index finger to a pulse duration of 200 ls. The initial current applied is 0mA and increases of 0.1 mA until the subject feels pain.
- Oral Health Impact Profile 49 (OHIP 49): provides a measure of social impact of oral disorders by providing a comprehensive measure of dysfunction, discomfort and disability resulting from the oral cavity conditions. The OHIP-49 is based on the adaptation of the World Health Organization classification.
- Pain detect Questionnaire
Pressor pain threshold
- Conditions
- Orofacial Pain
- Being tested
- real tDCS, sham tDCS
- Keywords
- Orofacial chronic pain, tDCS, Transcranial direct current stimulation, Brain stimulation
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real tDCSDevice
2 milliampere real direct current stimulation for 20 minutes daily for 5 days.
sham tDCSDevice
2 milliampere sham direct current stimulation for 20 minutes daily for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| sham tDCS | Active comparator | This group will receive sham-tDCS for 5 days. The anode will be placed on the primary motor cortex (M1) of the dominant hemisphere and the cathode on the contralateral supraorbital area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries. This continuous stimulation lasted 30 seconds, with an intensity of 1 milliampere. Receives: Device: sham tDCS |
| real tDCS | Experimental | This group will receive continuous stimulation lasting 20 minutes daily, for 5 days.
Transcranial direct current stimulation (tDCS) will be administered as follows. The anode will be placed on the primary motor cortex (M1) of the dominant hemisphere and the cathode on the contralateral supraorbital area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries. This continuous stimulation lasted 20 minutes, with an intensity of 1 milliampere. Receives: Device: real tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Visual Analogue Scale (VAS) for pain
Visual analogue scale measure for pain. Score range from 0-10. For rating overall pain: mild = 1-3, moderate = 4-7, severe = 8-10 For rating Chronic Pain, excellent internal consistency for a single pair of rating between Numeric Pain Rating Scale and Visual Analogue Scale (r = 0.86)
Measured: 1) one day pre-tDCS 5 days treatment. 2) Every day, for 5 days pre and post tDCS stimulation. 3) one day post tDCS 5 days treatment. 4)Follow up at one month.
Secondary outcomes (6)
Research Diagnostic Criteria Temporomandibular disorders (RDC/TMD) AXIS I
Diagnostic classification for temporomandibular disfunction.
Measured: 1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up
Research Diagnostic Criteria Temporomandibular disorders RDC/TMD AXIS II
Behavioral questionnaire (7 questions about chronic pain severity) which evaluates chronic pain following the graded scale for chronic pain.
Measured: 1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up
Symptoms Checklist 90-R scales (SCL 90-R)
Depression and anxiety assessment for non-specific physical symptoms.
Measured: 1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up
Electrical and pressure pain threshold
The device for assessing pain is a high voltage stimulator provides high voltage pulses of constant current up to 100 milliampere, pulses are of short duration and the output current is variable ranging between 0 and 100 milliampere. This device is used to evaluate the pain perception threshold by applying electrical stimulation to the index finger to a pulse duration of 200 ls. The initial current applied is 0 milliampere and increases of 0.1 milliampere until the subject feels pain.
Measured: 1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up
Oral Health Impact Profile 49 (OHIP 49)
Provides a measure of social impact of oral disorders by providing a comprehensive measure of dysfunction, discomfort and disability resulting from the oral cavity conditions. The OHIP-49 is based on the adaptation of the World Health Organization classification.
Measured: 1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up
Pain detect Questionnaire (PD-Q)
The PD-Q is a reliable screening tool with high sensitivity, specificity and positive predictive accuracy.
Simple, patient-based, easy-to-use screening questionnaires can determine the prevalence of neuropathic pain components both in individual low back pain patients and in heterogeneous cohorts of such patients. Since NeP correlates with more intense pain, more severe co-morbidity and poorer quality of life, accurate diagnosis is a milestone in choosing appropriate therapy.
Measured: 1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionFeb 2014
Why it stopped: We decided to stopped the study because we have difficulties in recruiting subjects phase.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orofacial 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Straudi, MD, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883245
- Sponsor's protocol ID
- Orofacial pain_tDCS
- Status last verified
- Jan 2014
- First submitted
- 18 Jun 2013
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation (tDCS) in Patients With Chronic Orofacial Pain Unresponsive to Conventional Treatment. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01883245
- Acronym / sponsor ID
- Orofacial pain_tDCS
- Conditions
- Orofacial Pain
- Keywords
- Orofacial chronic pain, tDCS, Transcranial direct current stimulation, Brain stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We decided to stopped the study because we have difficulties in recruiting subjects phase.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Jun 2013 (estimated)
- 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.
Patients affected by chronic orofacial pain represent an emergent medical problem due to the lack of knowledge on the cause, pathophysiology and psychology of many of these conditions, that belongs to a multifactorial origin.
Particularly, temporomandibular joint disorders involve a series of symptoms that refers both to intrinsic and extrinsic joint conditions where pain can be associated to a reduction of the joint movement, click or to other sounds of the joint.
The lack of a recognized causal therapy led to the suggestion of many treatment modalities with a multidisciplinary approach for the management of symptoms that include the use of occlusal splints, physiotherapy-speech therapy, behavioral and physical therapy, drugs, chirurgical approaches. In most cases these strategies together allow the control of the symptoms, even though they aren't completely resolutive.
In these patients is frequent chronic pain and ineffectiveness of common drugs used.
It has been demonstrated how transcranial electrical brain stimulation with direct current (tDCS) is able to reduce the intensity and the duration of chronic pain.
Stimulating the motor cortex can reduce pain by modulating brain activities in the areas involved in cerebral circuits controlling pain, such as thalamus, facilitating the descendant inhibitory mechanisms and enhancing the number of opiates receptors.
This clinical trial is based on the evaluation of the effects of tDCS on pain and on activities daily living (ADL) participation patients with chronic orofacial pain that don't respond to other treatments.
Detailed description
Inclusion criteria:
- Male and female between 18 and 75 years old
- Clinic history of previous orofacial and/or dental surgery
- Chronic orofacial pain for more than a year measurable by the VAS more than 3 .
- Pain not responsive to pharmacological treatment (analgesic, anti inflammatory, opiaces, antidepressant drugs and physiotherapy modalities)
Outcome measures:
Subjects will be assessed before the beginning of the treatment (T0), after tDCS (T1) and after one month of stimulation(T2) .
In the two weeks prior to T0 the patient will be asked in a questionnaire to report daily the level of pain, anxiety and state of mind using the VAS. This period of observation is necessary for the patient to get used to these measures and to underline possible intra-subject changing.
- Clinic scales
-Visual Analogue Scale (VAS): it is one of the most used between scales for pain evaluation [18]
RDC/TMD AXIS I: diagnostic classification for temporomandibolar disfunction. RDC/TMD AXIS II: behavioral questionnaire (7 questions about chronic pain severity) which evaluates chronic pain following the graded scale for chronic pain.
- Symptoms Checklist-90-R scales (SCL 90-R): Depression and anxiety assessment for non-specific physical symptoms
- electrical pain threshold: The Digitimer High Voltage Stimulator model DS74 provides high voltage pulses of constant current up to 100mA, pulses are of short duration and the output current is variable ranging between 0 and 100mA. The Digitimer is used to evaluate the pain perception threshold by applying electrical stimulation to the index finger to a pulse duration of 200 ls. The initial current applied is 0mA and increases of 0.1 mA until the subject feels pain.
- Oral Health Impact Profile 49 (OHIP 49): provides a measure of social impact of oral disorders by providing a comprehensive measure of dysfunction, discomfort and disability resulting from the oral cavity conditions. The OHIP-49 is based on the adaptation of the World Health Organization classification.
- Pain detect Questionnaire
Pressor pain threshold
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham tDCS | Active comparator | Device: sham tDCSThis group will receive sham-tDCS for 5 days. The anode will be placed on the primary motor cortex (M1) of the dominant hemisphere and the cathode on the contralateral supraorbital area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries. This continuous stimulation lasted 30 seconds, with an intensity of 1 milliampere. |
| real tDCS | Experimental | Device: real tDCSThis group will receive continuous stimulation lasting 20 minutes daily, for 5 days. Transcranial direct current stimulation (tDCS) will be administered as follows. The anode will be placed on the primary motor cortex (M1) of the dominant hemisphere and the cathode on the contralateral supraorbital area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries. This continuous stimulation lasted 20 minutes, with an intensity of 1 milliampere. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female between 18 and 75 years old
- Clinic history of previous orofacial and/or dental surgery
- Chronic orofacial pain for more than a year measurable by the VAS more than 3 .
- Pain not responsive to pharmacological treatment (analgesic, anti inflammatory, opiates, antidepressant drugs and physiotherapy modalities)
Key exclusion criteria (4 listed)
- Contraindication to tDCS: presence of metallic implants that can be stimulated, moved or overheated by electric current, positive anamnesis for epilepsy, implantable systems ( ventriculoperitoneal shunt, pacemaker, intracranial pumps, intracranial metallic systems)
- Major neurological or psychiatric pathologies
- Pregnancy
- Severe hepatorenal and cardiopulmonary diseases
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 |
|---|---|---|
| real tDCS2 milliampere real direct current stimulation for 20 minutes daily for 5 days. | Device | real tDCS |
| sham tDCS2 milliampere sham direct current stimulation for 20 minutes daily for 5 days. | Device | sham tDCS |
Primary outcome
Change from baseline in Visual Analogue Scale (VAS) for pain
Time frame: 1) one day pre-tDCS 5 days treatment. 2) Every day, for 5 days pre and post tDCS stimulation. 3) one day post tDCS 5 days treatment. 4)Follow up at one month.
Visual analogue scale measure for pain. Score range from 0-10. For rating overall pain: mild = 1-3, moderate = 4-7, severe = 8-10 For rating Chronic Pain, excellent internal consistency for a single pair of rating between Numeric Pain Rating Scale and Visual Analogue Scale (r = 0.86)
6 secondary outcomes
Research Diagnostic Criteria Temporomandibular disorders (RDC/TMD) AXIS I
Time frame: 1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up
Research Diagnostic Criteria Temporomandibular disorders RDC/TMD AXIS II
Time frame: 1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up
Symptoms Checklist 90-R scales (SCL 90-R)
Time frame: 1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up
Electrical and pressure pain threshold
Time frame: 1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up
Oral Health Impact Profile 49 (OHIP 49)
Time frame: 1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up
Pain detect Questionnaire (PD-Q)
Time frame: 1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up
Results and safety
The study was stopped early (reason given: We decided to stopped the study because we have difficulties in recruiting subjects phase.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
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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 Phase 2 study testing real tDCS in people with Orofacial Pain, run by University Hospital of Ferrara at 1 site in Italy.
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 4 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: stopped early, as of the sponsor's last update on 19 Mar 2014. 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 Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: We decided to stopped the study because we have difficulties in recruiting subjects phase.). Results are not available in the source record.
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?
Change from baseline in Visual Analogue Scale (VAS) for pain (time frame: 1) one day pre-tDCS 5 days treatment. 2) Every day, for 5 days pre and post tDCS stimulation. 3) one day post tDCS 5 days treatment. 4)Follow up at one month.). 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 19 Mar 2014.