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

NCT02330315 | Completed

• 1 other identifier: 2014P002496
• Study Type: interventional
• Target: 28
• 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

  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).

  Measured for approximately 2 months

Secondary Outcomes (13)

• Changes in Mood

  Measured for approximately 2 months

• Changes in cognition, attention, and focus

  Measured for approximately 2 months

• Adverse Events

  Measured for approximately 2 months

• Physical Examinations

  Measured for approximately 2 months

• Single Leg Standing Balance Test

  Measured for approximately 2 months

Study Arms (2)

Active tDCS + Active TUS

EXPERIMENTAL

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).

Device: transcranial direct current stimulation (tDCS); Device: transcranial ultrasound (TUS)

Sham tDCS + Sham TUS

SHAM COMPARATOR

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Device: transcranial direct current stimulation (tDCS); Device: transcranial ultrasound (TUS)

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.

Active tDCS + Active TUS; Sham tDCS + Sham TUS

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.

Active tDCS + Active TUS; Sham tDCS + Sham TUS

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 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

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 Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Timothy Wagner, PhD

  Highland Instruments, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: January 1, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (1)