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

NCT ID: NCT02723929

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2026-12-07

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

Study Design

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

Study Groups

Active Electrical Stim/Active Ultrasound

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

Group Type: EXPERIMENTAL

active low-intensity transcranial electrical stimulation/active transcranial ultrasound

Intervention Type: 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 Electrical Stim/Sham Ultrasound

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

Group Type: SHAM_COMPARATOR

Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound

Intervention Type: 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.

Interventions

active low-intensity transcranial electrical stimulation/active transcranial ultrasound

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.

Intervention Type: DEVICE

Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Able to provide informed consent to participate in the study.

2. Subjects between 18-85 years old.

3. Diagnosis of chronic osteoarthritis with pain of either knee as self-reported.

4. Existing knee pain of at least 3 on a 0-10 VAS scale on average over the past 6 months.

5. Pain of at least 3 on a 0-10 VAS scale on average over the week prior to the first stimulation session.

6. 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.

7. Having the ability to feel pain as self-reported.

Exclusion Criteria

1. Pregnancy or trying to become pregnant in the next 6 months.

2. History of alcohol or drug abuse within the past 6 months as self-reported

3. Contraindications to transcranial brain stimulation or TUS, i.e. implanted brain medical devices or implanted brain metallic devices.

4. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).

5. Epilepsy.

6. Use of carbamazepine within the past 6 months as self-reported.

7. Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)

8. History of unexplained fainting spells as self-reported.

9. Head injury resulting in more than a momentary loss of consciousness

10. History of neurosurgery as self-reported.

• 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

Charlestown, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016P000486

Identifier Type: -

Identifier Source: org_study_id