Clinical trial NCT03371225: Optimized tDCS for Fibromyalgia: Targeting the Endogenous Pain Control System
Official title: Optimized tDCS for Fibromyalgia: Targeting the Endogenous Pain Control System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: This trial aims at understanding the mechanisms of optimized transcranial direct current stimulation (tDCS) (16 tDCS sessions combined with exercise)\] on pain control. Optimized tDCS can lead to stronger engagement of the endogenous pain regulatory system that will ultimately lead to increased pain relief in patients with fibromyalgia (FM). Therefore, the investigators designed a 2x2 factorial mechanistic trial \[tDCS (active and sham) and aerobic exercise (AE) (active and control)\] to evaluate the effects of 4 weeks of tDCS coupled with exercise on the endogenous pain regulatory system assessed by conditioned pain modulation (CPM) and central sensitization as assessed by temporal slow pain summation (TSPS), and compared to either intervention alone and to no intervention.

Detailed description: Recent evidence has suggested that FM pain can be related to deficits in pain endogenous regulatory control and that novel non-pharmacological interventions, such as tDCS can modulate this system and, consequently, reduce pain intensity. Widespread pain in FM is thought to represent enhanced pain sensitivity that is maintained by central mechanisms. This suggests changes in the descending pain control mechanisms and a possible relationship with the central sensitization phenomenon. Recent evidence has suggested that pain inhibitory pathways are affected in FM; thus, further understanding these pathways' role can significantly change how the treatment of this condition. In this study the investigators will test the effects of two interventions -tDCS and aerobic exercise - on the modulation of the endogenous inhibitory pain system in fibromyalgia.

Eligibility criteria: Inclusion Criteria:

1. Age range 18-65 years,
2. Diagnosis of FM pain according to the ACR 2010 criteria (existing pain for more than 6 months with an average of at least 4 on a 0-10 VAS scale) without other comorbid chronic pain diagnosis,
3. Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine,
4. Must have the ability to feel sensation by Von-Frey fiber on the forearm,
5. Able to provide informed consent to participate in the study.

Exclusion Criteria:

1. Clinically significant or unstable medical or psychiatric disorder,
2. history of substance abuse within the past 6 months as self-reported (if subject reports a history of substance abuse, we will confirm using DSM V criteria),
3. Previous significant neurological history (e.g., traumatic brain injury), resulting in neurological deficits, such as cognitive or motor deficits, as self-reported,
4. Previous neurosurgical procedure with craniotomy,
5. Severe depression (If a patient scores \>30 on the Beck Depression Inventory, one will obtain clearance. If one does not pass the medical clearance, one will not be included in the study)
6. Pregnancy (as the safety of tDCS in pregnant population (and children) has not been assessed (though risk is non-significant), the investigators will exclude pregnant women (and children). Women of child-bearing potential will be required to take a urine pregnancy test during the screening process and at every week of stimulation),
7. Current opiate use in large doses (more than 30mg of oxycodone/hydrocodone or 7.5mg of hydromorphone (Dilaudid) or equivalent),
8. Patients will be excluded when they have increased risk for exercise

Primary outcomes:
measure: Conditioning Pain Modulation (CPM)
timeFrame: 6 weeks
measure: Temporal Slow Pain Summation (TSPS)
timeFrame: 6 weeks
Secondary outcomes:
measure: TMS
timeFrame: 6 weeks
measure: EEG
timeFrame: 6 weeks
measure: Average Pain Intensity as Assessed by Modified Brief Pain Inventory (BPI) - short form
timeFrame: 6 weeks
measure: Revised Fibromyalgia Impact Questionnaire (FIQ-R)
timeFrame: 6 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: 6 weeks
measure: Medication Use Questionnaire and Diary
timeFrame: 6 weeks
measure: Quality of Life Scale (QoLS)
timeFrame: 6 weeks
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 6 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 weeks
measure: Physical performance
timeFrame: 6 weeks
measure: tDCS Adverse Effects Questionnaire
timeFrame: 6 weeks
measure: Exercise Adverse Effects
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Spaulding Rehabilitation Hospital for Continuing Care
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Felipe Fregni, MD PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castelo-Branco L, Uygur Kucukseymen E, Duarte D, El-Hagrassy MM, Bonin Pinto C, Gunduz ME, Cardenas-Rojas A, Pacheco-Barrios K, Yang Y, Gonzalez-Mego P, Estudillo-Guerra A, Candido-Santos L, Mesia-Toledo I, Rafferty H, Caumo W, Fregni F. Optimised transcranial direct current stimulation (tDCS) for fibromyalgia-targeting the endogenous pain control system: a randomised, double-blind, factorial clinical trial protocol. BMJ Open. 2019 Oct 30;9(10):e032710. doi: 10.1136/bmjopen-2019-032710.