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

Chronic Pain Clinical Trial

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).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02954432
• Other study ID #: 2016P001956
• Status: Active, not recruiting
• Start date: November 2016
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Chronic Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Network Research Institute	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	Highland Instruments, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Mechanical Temporal Summation (Hand)	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.	Baseline and 3.5 months
Primary	Changes in Conditional Pain Modulation (Hand)	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.	Baseline and 3.5 months
Primary	Changes in Pain	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.	Baseline and 3.5 months