Clinical trial NCT02723175: The Effects of CBT and tDCS on Fibromyalgia Patients
Official title: The Effects of Cognitive Behavioral Therapy (CBT) and Transcranial Direct Current Stimulation (tDCS) on Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Chronic Pain
Keywords: Fibromyalgia
Pain
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2016-03-30
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients with fibromyalgia will complete questionnaires, six cognitive behavioral therapy sessions, quantitative sensory testing before and after the six therapy sessions, and undergo 30 minutes of tDCS during each of the six therapy sessions.

Eligibility criteria: Inclusion Criteria:

1. Meet the American College of Rheumatology criteria for diagnosis of fibromyalgia for at least 1 year.
2. Between the ages of 21 and 85

Exclusion Criteria:

1. Other chronic pain conditions
2. on chronic opioid therapy
3. history of seizures
4. are or might be pregnant
5. metal/electronic implants or devices above the waist
6. moderate to severe depression (HDRS \>19)
7. moderate to severe anxiety (BAI \>16)
8. Latex allergy
9. Psychiatric illness other than mild depression or anxiety
10. on medications that lower seizure threshold

Primary outcomes:
measure: Baseline Quantitative Sensory Testing (QST)
timeFrame: Before Treatment
measure: Post Baseline Quantitative Sensory Testing (QST)
timeFrame: One week Post Treatment
Secondary outcomes:
measure: The Beck Depression Inventory (BDI) at Baseline
timeFrame: Before Treatment
measure: The Beck Anxiety Inventory (BAI) at Baseline
timeFrame: Before Treatment
measure: Brief Pain Inventory-Average Pain at Baseline
timeFrame: Before Treatment
measure: Percent Change in Average Daily Pain at Treatment Visit 3
timeFrame: Treatment Session 3 (week 3)
measure: Affective Subscale of McGill Pain Questionnaire at Baseline
timeFrame: Before Treatment
measure: The Short-Form 12 Healthy Survey at Baseline
timeFrame: Before Treatment
measure: The Fibromyalgia (FM) Impact Questionnaire at Baseline
timeFrame: Before Treatment
measure: The Beck Depression Inventory (BDI) at 1 Month Follow up
timeFrame: 1 month follow up
measure: The Beck Anxiety Inventory (BAI) at 3 Month Follow Up
timeFrame: 3 Month Follow Up
measure: Brief Pain Inventory-Average Pain at 1 Month Follow Up
timeFrame: 1 Month Follow Up
measure: Percent Change in Average Daily Pain at Treatment Visit Six
timeFrame: Treatment Session 6 (week 6)
measure: Percent Change in Average Daily Pain at 1 Month Follow Up
timeFrame: 1 Month Follow Up
measure: Percent Change in Average Daily Pain at 3 Month Follow Up
timeFrame: 3 Month Follow Up
measure: Affective Subscale of McGill Pain Questionnaire at 1 Month Follow Up
timeFrame: 1 Month Follow Up
measure: The Short-Form 12 Healthy Survey at 1 Month Follow Up
timeFrame: 1 Month Follow Up
measure: The Fibromyalgia (FM) Impact Questionnaire at 1 Month Follow Up
timeFrame: 1 Month Follow Up
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jeffrey Borckardt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: