Trial · NCT07203339
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation of Pain Interference | Participants will undergo weekly home-based assessments during both the run-in period (Weeks 1 to 3) and the treatment phase (Weeks 4 to 7), as well as at 3, 6, and 12 months after the end of the intervention | The Brief Pain Inventory (BPI) assesses pain intensity and interference across seven domains, generating a global interference index using 0-10 scales. |
| Primary | Patient Global Impression of Improvement | To be assessed at Visit 4, after completing the four-week treatment with either active (a-tDCS), s-tDCS), or duloxetine | Patient Global Impression of Improvement (PGI-I): A 7-point scale that assesses the patient's overall perception of change in their condition, ranging from 'very much worse' (1) to 'very much improved' (7). Higher scores indicate greater perceived improvement (e.g., reduced symptoms or better functioning), while lower scores reflect worsening of symptoms or condition. |
| Primary | Impact of fibromyalgia symptoms on quality of life | Participants will be assessed at Visit 1 (prior to the run-in period), at Visit 4 (after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine), and again at 3, 6, and 12 months following the end of the treatment. | Fibromyalgia Impact Questionnaire (FIQ): Brazilian version assessing quality of life across function, overall impact, and symptoms. Scores range from 0 to 100, with higher scores indicating greater impact of fibromyalgia on the individual's daily life and functioning. |
| Primary | Cognitive symptoms | Participants will be assessed at Visit 1 (before the run-in period), at Visit 4 (after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine), and again at 3, 6, and 12 months after the end of the treatment. | Barkley Deficits in Executive Functioning Scale (Short Form).Each item is rated on a Likert scale from 1 (never or rarely) to 4 (very often), resulting in a total score range of 20 to 80, with higher scores indicating greater executive functioning impairment |
| Primary | Function of the descending pain inhibitory system | Participants will be assessed at Visit 1 (before the run-in period) and at Visit 4 (after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine). | Conditioned Pain Modulation (CPM) test: This test assesses descending pain inhibition. This test assesses the efficiency of descending pain inhibitory pathways. Pain intensity is rated using a verbal numerical rating scale (0 = no pain to 10 = worst possible pain) before (T0) and during (T1) cold-water immersion. The CPM effect is calculated as the difference between pain ratings at T0 and T1, with greater reductions indicating more effective pain inhibition. |
| Primary | Cortical Electrical Activity | Participants will be assessed at Visit 1 (before the run-in period) and at Visit 4 (after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine). | Cortical electrical activity will be assessed using resting-state electroencephalography (EEG). Recordings will be performed in a quiet room, with participants seated comfortably and instructed to remain relaxed and still. EEG data will be collected during eyes-closed and eyes-open conditions using a 64-channel EEG system. Signals will be recorded with a band-pass filter of 0.3-200 Hz and a sampling rate of 250 Hz. Spectral power measures will be analyzed to characterize cortical oscillatory activity associated with pain processing and central sensitization in fibromyalgia. |
| Secondary | Depressive Symptoms | Assessment timepoints: Baseline; Week 8 (Visit 4/after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine); 3 months post-treatment; 6 months post-treatment; 12 months post-treatment. | Assessed using the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire with total scores ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms |
| Secondary | Subjective Sleep Quality | Assessment timepoints: Baseline; Week 8 (Visit 4/after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine); 3 months post-treatment; 6 months post-treatment; 12 months post-treatment. | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-questionnaire that evaluates sleep quality over the past month. It generates a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. |
| Secondary | Circadian Profile (Chronotype) | Assessment timepoints: Baseline; Week 8 (Visit 4/after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine); 3 months post-treatment; 6 months post-treatment; 12 months post-treatment. | Chronotype will be measured using the Munich ChronoType Questionnaire (MCTQ) which evaluates individual sleep-wake patterns and chronotype based on the timing of sleep on workdays and free days. The key metric is the mid-sleep point on free days (MSF), which is based on sleep onset and wake-up times. The corrected version (MSFsc) accounts for workweek sleep debt and better reflects chronotype: lower values indicate morning types; higher values, evening types. |
| Secondary | Objective Sleep and Activity (Actigraphy) | Actigraph use during the run-in period (Weeks 1 to 3) and throughout the treatment phase (weeks 4 to 7) | Actigraphy (accelerometer) assesses sleep quality and physical mobility. Mean values are calculated across days for parameters such as total sleep time, sleep efficiency, and activity levels. Higher sleep efficiency and activity indicate better sleep quality and physical functioning; lower values suggest disturbances or impairment. |
| Secondary | Analgesic Use | Analgesic use during the run-in period (Weeks 1 to 3) and throughout the treatment phase (Weeks 4 to 7). | The use of analgesics will be assessed by recording the number of tablets of each analgesic taken per week during the run-in period (Weeks 1 to 3) and throughout the treatment phase (Weeks 4 to 7) |
| Secondary | Functional Capacity | Assessment timepoints: Baseline; Week 8 (Visit 4/after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine); 3 months post-treatment; 6 months post-treatment; 12 months post-treatment. | Functional interference of pain is assessed using the Brazilian Profile of Chronic Pain: Screen (B-PCP: S), which captures pain intensity, interference in daily life, and emotional impact. Scores range from 0 to 100, with higher scores indicating greater pain-related interference and effects. |
| Secondary | Heat Pain Threshold | Assessment timepoints: Baseline; Week 8 (Visit 4/after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine) | Heat pain threshold will be assessed via quantitative sensory testing (QST) on the left forearm using a thermode that increases temperature from 30°C to 52°C at a rate of 1°C per second. The pain threshold is calculated as the average temperature at which pain is first reported across three trials. Higher values indicate greater pain threshold. |
| Secondary | Pressure Pain Threshold | Assessment timepoints: Baseline; Week 8 (Visit 4/after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine) | Pressure pain threshold will be measured using a pressure algometer applied to the left forearm. The threshold is defined as the point at which pressure sensation becomes painful, averaged across three trials. Higher values indicate lower pain sensitivity. |
| Secondary | Cold Pressor Test Pain Intensity | Assessment timepoints: Baseline; Week 8 (Visit 4/after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine) | Cold Pressor Test: Non-dominant hand immersed in ice water (\~1°C) for up to 2 minutes with continuous movement. Pain intensity is continuously rated via electronic visual analog scale (0-100%), enabling calculation of peak pain, mean pain, and area under the curve (AUC).allowing calculation of peak pain, mean pain, and area under the curve (AUC). Higher scores reflect greater pain intensity. |
| Secondary | Patient-Defined Goals | Assessment timepoints: Baseline; Week 8 (Visit 4/after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine) | Patients will select three priority areas-physical, psychological, functional, or social-and define personalized, measurable goals at Visit 1 (V1) and evaluate them at the end of the treatment period (Visit 4). |
| Secondary | Treatment Adherence | Assessment timepoints: Week 8 (Visit 4/after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine) | tDCS adherence: Assessed by the number and duration of valid sessions recorded by the device software, based on impedance and resistance parameters. Pharmacological treatment adherence: Assessed by pill count at Visit 3 and Visit 4, based on the number of capsules consumed |
| Secondary | Side Effects | Assessment timepoints: During the run-in period (Weeks 1 to 3) and throughout the treatment phase (Weeks 4 to 7). | The adverse effects of duloxetine will be assessed weekly throughout the run-in period (Weeks 1 to 3) and during the treatment phase (Weeks 4 to 7) using structured questionnaires that include common side effects such as nausea, dry mouth, dizziness, and somnolence, which will be recorded as 'yes' or 'no'. Adverse effects related to tDCS-such as tingling, itching, burning, or headache-will be assessed weekly during the treatment phase (Weeks 4 to 7), also using 'yes' or 'no' responses. |
| Secondary | Satisfaction with Treatment | Assessment timepoints: Week 8 (Visit 4/after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine) | Assessed using the Numeric Satisfaction with Treatment Scale (NSTS), ranging from 0 (not at all satisfied) to 10 (extremely satisfied). |
| Secondary | Global Cognitive Function (MoCA) | Assessment timepoints: Baseline; Week 8 (Visit 4/after completing the four-week treatment with active [a-tDCS], sham [s-tDCS], or duloxetine) | Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a screening tool for global cognition. Scores range from 0 to 30, with higher scores indicating better cognitive performance. A score below 26 is suggestive of cognitive impairment |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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