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Active, Not Recruiting

NCT Number: NCT02954432

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Pain Chronic Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Primary location

Spaulding Rehabilitation Network Research Institute

Cambridge, Massachusetts, 02138, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in Mechanical Temporal Summation (Hand)

    Time frame: Baseline and 3.5 months

    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.

  2. Changes in Conditional Pain Modulation (Hand)

    Time frame: Baseline and 3.5 months

    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.

  3. Changes in Pain

    Time frame: Baseline and 3.5 months

    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.

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Collaborators

  • Highland Instruments, Inc.

Registry information

Official study 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).

Important dates

Study start
2016
Primary completion
2022
Study completion
2026
First posted
Nov 3, 2016
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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