N/A
Completed N=15
The Effects of CBT and tDCS on Fibromyalgia Patients
Source: ClinicalTrials.gov NCT02723175 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Baseline Quantitative Sensory Testing (QST) — 39.7063; 39.8286; 43.9563; 45.2036 Degrees Celsius
Summary
Investigators are seeking to determine the effects of CBT, anodal tDCS over left DLPFC, and combined CBT+ tDCS on clinical pain and functioning among a sample of patients with fibromyalgia. This study will be the first randomized, double-blind, controlled study of tDCS technology as an adjunctive pain management strategy for fibromyalgia pain. Data from this trial will likely yield information regarding the feasibility and efficacy of tDCS+CBT as a chronic pain-management approach.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Quantitative Sensory Testing (QST) |
39.7063; 39.8286; 43.9563; 45.2036; 46.1531; 47.2036 | — |
| PRIMARY Post Baseline Quantitative Sensory Testing (QST) |
39.2350; 38.9083; 42.3050; 44.1042; 44.1050; 46.0417 | — |
| SECONDARY The Beck Depression Inventory (BDI) at Baseline |
21.38; 23.86 | — |
| SECONDARY The Beck Anxiety Inventory (BAI) at Baseline |
12.75; 23.00 | — |
| SECONDARY Brief Pain Inventory-Average Pain at Baseline |
5.69; 7.06 | — |
| SECONDARY Percent Change in Average Daily Pain at Treatment Visit 3 |
-13.29; -3.73 | — |
| SECONDARY Affective Subscale of McGill Pain Questionnaire at Baseline |
5.625; 6.714 | — |
| SECONDARY The Short-Form 12 Healthy Survey at Baseline |
30.13; 31.14 | — |
| SECONDARY The Fibromyalgia (FM) Impact Questionnaire at Baseline |
3.46; 3.96 | — |
| SECONDARY The Beck Depression Inventory (BDI) at 1 Month Follow up |
15.40; 17.40 | — |
| SECONDARY The Beck Anxiety Inventory (BAI) at 3 Month Follow Up |
14.75; 16.75 | — |
| SECONDARY Brief Pain Inventory-Average Pain at 1 Month Follow Up |
3.78; 3.53 | — |
| SECONDARY Percent Change in Average Daily Pain at Treatment Visit Six |
-24.17; -5.32 | — |
| SECONDARY Percent Change in Average Daily Pain at 1 Month Follow Up |
-36.11; -23.71 | — |
| SECONDARY Percent Change in Average Daily Pain at 3 Month Follow Up |
-31.15; -48.93 | — |
| SECONDARY Affective Subscale of McGill Pain Questionnaire at 1 Month Follow Up |
4.2; 5.0 | — |
| SECONDARY The Short-Form 12 Healthy Survey at 1 Month Follow Up |
29.60; 31.20 | — |
| SECONDARY The Fibromyalgia (FM) Impact Questionnaire at 1 Month Follow Up |
3.31; 2.69 | — |
Eligibility Criteria
Inclusion Criteria
- Meet the American College of Rheumatology criteria for diagnosis of fibromyalgia for at least 1 year.
- Between the ages of 21 and 85
Exclusion Criteria
- Other chronic pain conditions
- on chronic opioid therapy
- history of seizures
- are or might be pregnant
- metal/electronic implants or devices above the waist
- moderate to severe depression (HDRS >19)
- moderate to severe anxiety (BAI >16)
- Latex allergy
- Psychiatric illness other than mild depression or anxiety
- on medications that lower seizure threshold
Data sourced from ClinicalTrials.gov (NCT02723175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.