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

NCT02723929 | Active Not Recruiting Results

• 1 other identifier: 2016P000486
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Osteoarthritis

Keywords

transcranial direct current stimulation; transcranial ultrasound; non-invasive brain stimulation

Outcome Measures

Primary Outcomes (1)

• Changes in Pain Scale as Measured by VAS

  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

  Baseline and 8 weeks

Secondary Outcomes (6)

• Average Daily Dose of Acetaminophen Equivalent

  8 weeks

• Changes in Pain Scale as Measured by VAS

  Baseline and 4 weeks post-stimulation

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

  Baseline and 8 weeks

• Percentage Change From Baseline in the Single Leg Standing Balance Test

  Baseline and 8 weeks

• Percentage Change From Baseline in the Step Test

  Baseline and 8 weeks

Study Arms (2)

Active Electrical Stim/Active Ultrasound

EXPERIMENTAL

Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.

Device: active low-intensity transcranial electrical stimulation/active transcranial ultrasound

Sham Electrical Stim/Sham Ultrasound

SHAM COMPARATOR

Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.

Device: Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound

Interventions

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.

Active Electrical Stim/Active Ultrasound

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.

Sham Electrical Stim/Sham Ultrasound

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 18-85 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

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: GT60
• 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: tDCS and tUS

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 31, 2016
• Study Start: September 1, 2016
• Primary Completion: August 15, 2019
• Study Completion (Estimated): December 7, 2026
• Last Updated: September 29, 2025
• Results First Posted: August 17, 2021

Record last verified: 2025-09

Locations

US (1)