Clinical trial NCT02954432: Effects of tDCS and TUS on the Perception of Pain and Functional Limitations Due to Non-Specific Chronic Low Back Pain
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) on the Perception of Pain and Functional Limitations Due to Non-Specific Chronic Low Back Pain (NSCLBP).
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Pain
Chronic Low Back Pain
Keywords: transcranial Direct Current Stimulation
Transcranial Ultrasound
non-invasive brain stimulation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Highland Instruments, Inc.
First posted: 2016-11-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase II
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain and functional limitations in subjects with NSCLBP. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.


Eligibility criteria: Inclusion Criteria:

1. Able to provide informed consent to participate in the study
2. Subjects between 18 to 85 years old
3. Subjects having non-specific chronic low back pain with existing pain for at least 3 months and having pain on at least half the days in the past 6 months with an average of at least 3 on a 0-10 visual analog scale (VAS) scale
4. Pain resistant (partial or no response) to common analgesics and medications for chronic pain used as initial pain management such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
5. Must have the ability to feel sensation by Von-Frey fiber on the forearm

Exclusion Criteria:

1. Subject is pregnant
2. Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices
3. History of alcohol or drug abuse within the past 6 months as self reported
4. Use of carbamazepine within the past 6 months as self reported
5. Suffering from severe depression (with a score of \>30 in the Beck Depression Inventory)
6. History of neurological disorders as self reported
7. History of unexplained fainting spells as self reported
8. History of severe head injury resulting in more than a momentary loss of consciousness as self reported
9. History of neurosurgery as self reported
10. Unstable pain
11. Large placebo responder
12. Low adherence during the run-in period
13. Low baseline pain

Primary outcomes:
measure: Changes in Mechanical Temporal Summation (Hand)
timeFrame: Baseline and 3.5 months
measure: Changes in Conditional Pain Modulation (Hand)
timeFrame: Baseline and 3.5 months
measure: Changes in Pain
timeFrame: Baseline and 3.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Spaulding Rehabilitation Network Research Institute
state: Massachusetts
Study officials:
References:
citation: Teixeira PEP, Pacheco-Barrios K, Uygur-Kucukseymen E, Machado RM, Balbuena-Pareja A, Giannoni-Luza S, Luna-Cuadros MA, Cardenas-Rojas A, Gonzalez-Mego P, Mejia-Pando PF, Wagner T, Dipietro L, Fregni F. Electroencephalography Signatures for Conditioned Pain Modulation and Pain Perception in Nonspecific Chronic Low Back Pain-An Exploratory Study. Pain Med. 2022 Mar 2;23(3):558-570. doi: 10.1093/pm/pnab293.