Effects of tDCS and TUS on the Perception of Pain and Functional Limitations Due to Non-Specific Chronic Low Back Pain

Active, not recruiting

Interventions: Device: transcranial Direct Current Stimulation (tDCS)
Device: Transcranial Ultrasound (TUS)

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.

Recruitment & Eligibility

Inclusion Criteria

Able to provide informed consent to participate in the study
Subjects between 18 to 85 years old
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
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.
Must have the ability to feel sensation by Von-Frey fiber on the forearm

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Active tDCS + Active TUS	Transcranial Ultrasound (TUS)	Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Sham tDCS + Sham TUS	transcranial Direct Current Stimulation (tDCS)	Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Active tDCS + Active TUS	transcranial Direct Current Stimulation (tDCS)	Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Sham tDCS + Sham TUS	Transcranial Ultrasound (TUS)	Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Primary Outcome Measures

Name	Time	Method
Changes in Conditional Pain Modulation (Hand)	Baseline and 3.5 months	Changes in Conditional Pain Modulation (CPM) will be measured in the hand in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in increasing the pain pressure threshold in subjects with non-specific chronic low back pain.
Changes in Mechanical Temporal Summation (Hand)	Baseline and 3.5 months	Changes in Mechanical Temporal Summation (TS) from hand will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in reducing pain of subjects with non-specific chronic low back pain.
Changes in Pain	Baseline and 3.5 months	Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to measure any changes in pain levels when subjects come in for sessions.