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

NCT ID: NCT02954432

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2026-09-30

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.

Conditions

Chronic Pain; Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

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 tDCS + Sham TUS

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

Group Type: SHAM_COMPARATOR

transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Highland Instruments, Inc.

INDUSTRY

Sponsor Role: collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Fregni, MD, PhD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Spaulding Rehabilitation Network Research Institute

Cambridge, Massachusetts, United States

Countries

United States

References

Teixeira PEP, Pacheco-Barrios K, Uygur-Kucukseymen E, Machado RM, Balbuena-Pareja A, Giannoni-Luza S, Luna-Cuadros MA, Cardenas-Rojas A, Gonzalez-Mego P, Mejia-Pando PF, Wagner T, Dipietro L, Fregni F. Electroencephalography Signatures for Conditioned Pain Modulation and Pain Perception in Nonspecific Chronic Low Back Pain-An Exploratory Study. Pain Med. 2022 Mar 2;23(3):558-570. doi: 10.1093/pm/pnab293.

Reference Type: DERIVED

PMID: 34633449 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016P001956

Identifier Type: -

Identifier Source: org_study_id