Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02723929

Effects of tDCS and tUS on Pain Perception in OA of the Knee

The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and functional limitations in people with osteoarthritis of the knee. 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 Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Primary location

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, 02129, 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 18-85 years old.
  • Diagnosis of chronic osteoarthritis with pain of either knee as self-reported.
  • Existing knee pain of at least 3 on a 0-10 VAS scale on average over the past 6 months.
  • Pain of at least 3 on a 0-10 VAS scale on average over the week prior to the first stimulation session.
  • Pain resistant 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.
  • Having the ability to feel pain as self-reported.

Exclusion criteria

  • Pregnancy or trying to become pregnant in the next 6 months.
  • History of alcohol or drug abuse within the past 6 months as self-reported
  • Contraindications to transcranial brain stimulation or TUS, i.e. implanted brain medical devices or implanted brain metallic devices.
  • Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
  • Epilepsy.
  • 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 unexplained fainting spells as self-reported.
  • Head injury resulting in more than a momentary loss of consciousness
  • History of neurosurgery as self-reported.

Treatment and study plan

active low-intensity transcranial electrical stimulation/active transcranial ultrasound

Device

Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for the full 20 minutes.

Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.

Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound

Device

Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes.

Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.

Primary outcomes

  1. Changes in Pain Scale as Measured by VAS

    Time frame: Baseline and 8 weeks

    Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee.

    The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain and is reported following the full course of therapy. Since we are using a difference, smaller values (negative) represent a better outcome

Secondary outcomes

  1. Average Daily Dose of Acetaminophen Equivalent

    Time frame: 8 weeks

    Analgesic use (average daily dose of acetaminophen equivalent)

  2. Changes in Pain Scale as Measured by VAS

    Time frame: Baseline and 4 weeks post-stimulation

    Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee.

    The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain. Since we are using a difference, smaller values (negative) represent a better outcome.

  3. Percentage Change in Diffuse Noxious Inhibitory Controls (DNIC) From Baseline

    Time frame: Baseline and 8 weeks

    This measures the endogenous pain modulatory pathway. This study will evaluate DNIC in pain patients using pressure as the test stimulus, and cold water as the conditioning stimulus. DNIC will be induced approximately 1-min later by having subjects immerse their hand into a water bath maintained at 10-12˚C for approximately 1 min. Parallel to the last 30s of DNIC conditioning (cold water immersion), the pressure test stimulus will be reapplied. DNIC response will be calculated as the difference between the average of pain ratings from the test stimulus minus the average of pain ratings during the conditioned stimulus. Larger percentage change means a better outcome.

  4. Percentage Change From Baseline in the Single Leg Standing Balance Test

    Time frame: Baseline and 8 weeks

    We will record the time (seconds) for which a subject is able to stand unsupported on one foot while looking straight ahead with hands on hips. Larger percentage change means a better outcome.

  5. Percentage Change From Baseline in the Step Test

    Time frame: Baseline and 8 weeks

    The subject was asked to stand unsupported with their feet parallel to each other in front of a step. We assessed the number of times the participant could place their foot up onto the step and return it to the floor over a 15-sec interval. Larger percentage change means a better outcome.

  6. Percentage Change in Functional Reach Test From Baseline

    Time frame: Baseline and 8 weeks

    Subject will be instructed to stand next to, but not touch the wall, and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. Smoothness of wrist movement is assessed as the subject was asked to outstretch their arm in a maximal forward reach, while maintaining a fixed base of support. Smoothness is dimensionless and is calculated as mean speed divided by peak speed. Larger percentage change means a better outcome.

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 Osteoarthritis of the Knee

Important dates

Study start
2016
Primary completion
2019
Study completion
2026
First posted
Mar 31, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.