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Effect of Noninvasive Neuromodulation on Chronic Pain

Primary Purpose

Temporomandibular Dysfunction (TMD)

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
active tDCS
active tDCS
sham tDCS
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Dysfunction (TMD) focused on measuring Analgesia, Facial pain, Transcranial Direct Current Stimulation, Temporomandibular disorders

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tatyanne FalcãoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

tDCS M1

tDCS DLPF

tDCS sham

Arm Description

active tDCS Participants will receive active transcranial direct current stimulation.

active tDCS Participants will receive active transcranial direct current stimulation.

tDCS Sham Participants will receive sham transcranial direct current stimulation.

Outcomes

Primary Outcome Measures

Change from baseline in Visual Analogic Scale
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.

Secondary Outcome Measures

Patient Global Impression of Change Scale (PGICS)
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).
State-Trait Anxiety Inventory
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).

Full Information

First Posted
September 14, 2017
Last Updated
September 14, 2017
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT03285685
Brief Title
Effect of Noninvasive Neuromodulation on Chronic Pain
Official Title
Effect of Noninvasive Neuromodulation on Chronic Pain and Anxiety Levels in Individuals With Temporomandibular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2017 (Anticipated)
Primary Completion Date
January 26, 2018 (Anticipated)
Study Completion Date
February 16, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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. 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. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Dysfunction (TMD)
Keywords
Analgesia, Facial pain, Transcranial Direct Current Stimulation, Temporomandibular disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS M1
Arm Type
Experimental
Arm Description
active tDCS Participants will receive active transcranial direct current stimulation.
Arm Title
tDCS DLPF
Arm Type
Experimental
Arm Description
active tDCS Participants will receive active transcranial direct current stimulation.
Arm Title
tDCS sham
Arm Type
Sham Comparator
Arm Description
tDCS Sham Participants will receive sham transcranial direct current stimulation.
Intervention Type
Device
Intervention Name(s)
active tDCS
Intervention Description
Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left M1 and cathodal over supraorbital contralateral area
Intervention Type
Device
Intervention Name(s)
active tDCS
Intervention Description
Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left DLPFC and cathodal over supraorbital contralateral area.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Visual Analogic Scale
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change Scale (PGICS)
Description
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).
Time Frame
4 months
Title
State-Trait Anxiety Inventory
Description
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).
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatyanne Falcão
Email
pesquisadtm@yahoo.com
Facility Information:
Facility Name
Tatyanne Falcão
City
João Pessoa
State/Province
Paraíba
Country
Brazil
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Noninvasive Neuromodulation on Chronic Pain

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