Effect of Noninvasive Neuromodulation on Chronic Pain

September 14, 2017 updated by: Tatyanne dos Santos Falcão Silva, Federal University of Paraíba

Effect of Noninvasive Neuromodulation on Chronic Pain and Anxiety Levels in Individuals With Temporomandibular Disorders

  1. BACKGROUND: Temporomandibular Dysfunction (TMD) is a disease characterized by a set of signs and symptoms that may include joint noise, pain in the mastication muscles, limitation of mandibular movements, facial pain, joint pain and / or dental wear. Pain appears as a very present and striking symptom, with a tendency to chronicity. This is a difficult treatment condition often associated with psychological factors such as anxiety. Chronic pain involved modifications in the neuronal excitability, therefore, the neuromodulation withTranscranial direct current stimulation (tDCS) appears as a possible strategy for the treatment. Some studies have shown improvement in subjects with chronic pain using tDCS, however, it needs further investigation of its therapeutic effect.
  2. PROBLEM: Despite the wide range of strategies used to treat patients with TMD, some patients have a temporary and / or unsatisfactory relief response, which generates hypotheses that emotional components often underlie treatment refractoriness, and development of a memory for pain. Thus, it is evident the need for a therapy that acts directly on the central nervous system (CNS). This action can occur through medications, however, many individuals are refractory or have side effects such as dependence and / or tolerance. In this way, the importance of new treatments involving neuromodulation and neuroplasticity mechanisms, such as tDCS, is highlighted, which may become a complementary alternative to the different types of treatment already in use. Besides corroborating with the need to give preference to reversible and non-invasive procedures.
  3. HYPOTHESIS: The investigators believe that the use of anodic tDCS in the treatment of patients with TMD presenting with chronic pain will have a positive effect, promoting a decrease in painful symptoms through a Central Nervous System (neuromodulation) action in comparison to placebo stimulation. Because of the mutual influence between pain and psychological factors, it is expected that the analgesic effect will have a positive effect on anxiety levels. In addition, it is believed that a more intense analgesic effect occurs in the DLPF stimulation group of the cortex compared to the M1 stimulation group, since this region demonstrates to be responsible for the processing of the emotional component of the pain, often underlying the refractoriness to treatment
  4. AIM: To evaluate and compare the efficacy of anodic tDCS, applied in different cortical regions (M1 and DLPFC), in the pain and anxiety levels in individuals with chronic pain due muscular TMD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • Paraíba
      • João Pessoa, Paraíba, Brazil
        • Recruiting
        • Tatyanne Falcão

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18-60 years, both male and female
  • Provide informed consent to participate in the study;
  • Having a diagnosis of muscular pain DTM according to IA and IB, axis I RDC/TMD
  • Visual analogic scale (VAS) score from 4 to 10 for six months or longer
  • Presence of moderate depressive symptoms through SCL-90 scale evaluation of Axis II, (RDC / TMD)
  • Not pregnant;
  • Not have contraindications to tDCS, such as metal implants on the head or implanted brain devices;
  • Not have history of alcohol or drugs abuse within the past 6 months as self-reported
  • Not use of carbamazepine within the past 6 months as self reported
  • Not have any history of epilepsy, stroke, moderate-to-severe traumatic brain injury or severe migraines
  • Not have history of neurosurgery as self-reported
  • Not have history of major psychiatric disorders such as schizophrenia and bipolar disorder
  • Not have any other previously diagnosed disorder with symptoms similar to the DTM, such as fibromyalgia.

Exclusion Criteria:

  • Two absences during treatment sessions;
  • During the research, go against some criteria of inclusion mentioned above, as in the case of women, getting pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: tDCS M1
active tDCS Participants will receive active transcranial direct current stimulation.
Device: active tDCS
Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left M1 and cathodal over supraorbital contralateral area
Device: active tDCS
Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left DLPFC and cathodal over supraorbital contralateral area.
EXPERIMENTAL: tDCS DLPF
active tDCS Participants will receive active transcranial direct current stimulation.
Device: active tDCS
Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left M1 and cathodal over supraorbital contralateral area
Device: active tDCS
Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left DLPFC and cathodal over supraorbital contralateral area.
SHAM_COMPARATOR: tDCS sham
tDCS Sham Participants will receive sham transcranial direct current stimulation.
Device: sham tDCS
The procedure is the same as for active tDCS anodal over left M1 and cathodal over supraorbital contralateral area, but the in the placebo tDCS the stimulation is non-active / sham.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Visual Analogic Scale
Time Frame: 4 months
The visual analogic scale allows us to convert subjective sensations as pain on numerical data. A 10cm scale where 0cm is no pain and 10cm the worse imaginable pain, will be used and the subjects will be asked to mark a point on the scale representing their pain. This instrument will be used to compare the VAS values before and after the intervention.
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Change Scale (PGICS)
Time Frame: 4 months
The Patient Global Impression of Change Scale (PGICS) is an understandable, adequate, easy-to-use instrument capable of measuring the perception of change in health status and satisfaction with the treatment of individuals with chronic musculoskeletal pain. It is a one-dimensional measurement instrument in which individuals rate their improvement associated with intervention on a 7-item scale ranging from 1 (no change) to 7 (Much better).
4 months
State-Trait Anxiety Inventory
Time Frame: 4 months
The STAI is used to evaluate objectively both aspects of anxiety: trait and state. Thus, the anxiety state will assess the level of anxiety at the specific time the test is performed and the anxiety trait will investigate the individual's willingness to react to stress situations. It is an instrument with 40 descriptive statements about the feelings of the person, distributed in two parts (trace and state of anxiety), in which each part is formed by 20 affirmations and the answers are given in scale of the type Likert of four points (1 - absolutely not the 4 - very much). The score in each questionnaire ranges from 20 to 80, with an anxiety level rating of: low (20 to 33), mean (33 to 49) and high (49 to 80).
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Paraíba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 26, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 16, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NeuroDTM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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