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

Purpose

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.

Conditions

  • Chronic Pain
  • Chronic Low Back Pain

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Phase II
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active tDCS + Active TUS 		Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
  • Device: transcranial Direct Current Stimulation (tDCS)
    Subjects will receive 20 minutes of either active or sham tDCS at an intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.
  • Device: Transcranial Ultrasound (TUS)
    Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
Sham Comparator
Sham tDCS + Sham TUS 		Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
  • Device: transcranial Direct Current Stimulation (tDCS)
    Subjects will receive 20 minutes of either active or sham tDCS at an intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.
  • Device: Transcranial Ultrasound (TUS)
    Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

More Details

Status
Active, not recruiting
Sponsor
Spaulding Rehabilitation Hospital

Study Contact