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

NCT02954432 | Active Not Recruiting Results

• 1 other identifier: 2016P001956
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

transcranial Direct Current Stimulation; Transcranial Ultrasound; non-invasive brain stimulation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Active tDCS + Active TUS

EXPERIMENTAL

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); Device: Transcranial Ultrasound (TUS)

Sham tDCS + Sham TUS

SHAM COMPARATOR

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); Device: Transcranial Ultrasound (TUS)

Interventions

transcranial Direct Current Stimulation (tDCS) 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.

Active tDCS + Active TUS; Sham tDCS + Sham TUS

Transcranial Ultrasound (TUS) 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.

Active tDCS + Active TUS; Sham tDCS + Sham TUS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Large placebo responder
• Low adherence during the run-in period
• Low baseline pain

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Highland Instruments, Inc.: collaborator

Study Sites (1)

Spaulding Rehabilitation Network Research Institute

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (1)

• 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.

  PMID: 34633449 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Felipe Fregni
• Organization: Spaulding Rehabilitation Hospital

Fregni.felipe@mgh.harvard.edu

6179526158

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Phase II

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 3, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2022
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 29, 2025
• Results First Posted: April 17, 2024

Record last verified: 2025-09

Locations

US (1)