Status unknownNCT03285685Updated Sep 18, 2017

Effect of Noninvasive Neuromodulation on Chronic Pain

A Phase 2 interventional study of active tDCS and active tDCS in Temporomandibular Dysfunction (TMD), sponsored by Federal University of Paraíba. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by Federal University of Paraíba · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 10
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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.

Conditions studied

Temporomandibular Dysfunction (TMD)

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Keywords

Analgesia
Facial pain
Transcranial Direct Current Stimulation
Temporomandibular disorders

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 10 participants (estimated)

Study arms

Experimental
tDCS M1
active tDCS Participants will receive active transcranial direct current stimulation.
Device: active tDCS
Experimental
tDCS DLPF
active tDCS Participants will receive active transcranial direct current stimulation.
Device: active tDCS
Sham comparator
tDCS sham
tDCS Sham Participants will receive sham transcranial direct current stimulation.
Device: sham tDCS

Interventions

Deviceactive tDCS
Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left M1 and cathodal over supraorbital contralateral area
Deviceactive tDCS
Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left DLPFC and cathodal over supraorbital contralateral area.
Devicesham 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 researchers measure

Primary outcomes

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.
Time frame: 4 months

Secondary outcomes

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).
Time frame: 4 months
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).
Time frame: 4 months

Study locations

1 of 1 sites recruiting

Tatyanne Falcão
João Pessoa, Paraíba, Brazil
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03285685
Lead sponsor: Federal University of Paraíba
Responsible party: Tatyanne dos Santos Falcão Silva (Tatyanne Falcão, Federal University of Paraíba) — Principal investigator
First posted: Sep 18, 2017
Start date: Oct 2, 2017 (estimated)
Primary completion: Jan 26, 2018 (estimated)
Completion: Feb 16, 2018 (estimated)
Last update: Sep 18, 2017

Study contacts

Tatyanne Falcão

Contact

pesquisadtm@yahoo.com

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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