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

Mass General Brigham

Status: Active, not recruiting

Conditions: Chronic Low Back Pain; Chronic Pain

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02954432

2016P001956

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Active tDCS + Active TUS

Experimental group

Description:

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).

Treatment:

Device: Transcranial Ultrasound (TUS)

Device: transcranial Direct Current Stimulation (tDCS)

Sham tDCS + Sham TUS

Sham Comparator group

Description:

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Treatment:

Device: Transcranial Ultrasound (TUS)

Device: transcranial Direct Current Stimulation (tDCS)