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.

Spaulding Rehabilitation Hospital1 site in 1 country28 target enrollmentMarch 2015

ConditionsChronic Pain Osteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Pain
Sponsor: Spaulding Rehabilitation Hospital
Enrollment: 28
Locations: 1
Primary Endpoint: Changes in Pain Scale
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

August 2016

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Spaulding Rehabilitation Hospital

Responsible Party

Principal Investigator

Felipe Fregni

Principal Investigator

Spaulding Rehabilitation Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in Pain Scale

Time Frame: Measured for approximately 2 months

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).