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

Spaulding Rehabilitation Hospital28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Pain Osteoarthritis

Interventions

transcranial direct current stimulation (tDCS)DEVICE

Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 the knee as self-reported. Prior to beginning baseline procedures this must be confirmed by medical records or a letter from the subject's physician. This document may either be brought in by the subject or retrieved by study staff after a medical release form is signed by the subject. After consent, if the subject fails to provide the necessary documentation or it cannot be retrieved by study staff the subject will be considered a screen fail. 4. Existing knee pain in the past 6 months of at least 3 on a 0-10 VAS scale on average. 5. 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. 6. 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.

Locations (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Changes in Pain Scale

Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in reducing pain in subjects with osteoarthritis knee pain. The investigators will also look at changes in the Von Frey assessment and pain pressure threshold (PPT).