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).
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Spaulding Rehabilitation Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Changes in Conditional Pain Modulation (Hand)
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Felipe Fregni, MD, PhD, MPH
Principal Investigator
Spaulding Rehabilitation Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Changes in Conditional Pain Modulation (Hand)
Time Frame: 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)
Time Frame: 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
Time Frame: 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.