Overview

This trial is active, not recruiting.

Conditions chronic pain, osteoarthritis
Treatments transcranial direct current stimulation (tdcs), transcranial ultrasound (tus)
Phase phase 1
Sponsor Spaulding Rehabilitation Hospital
Collaborator Highland Instruments, Inc.
Start date March 2015
End date June 2016
Trial size 28 participants
Trial identifier NCT02330315, 2014P002496

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
transcranial direct current stimulation (tdcs)
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)
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.
(Sham Comparator)
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
transcranial direct current stimulation (tdcs)
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)
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.

Primary Outcomes

Measure
Changes in Pain Scale
time frame: Measured for approximately 2 months

Secondary Outcomes

Measure
Changes in Mood
time frame: Measured for approximately 2 months
Changes in cognition, attention, and focus
time frame: Measured for approximately 2 months
Adverse Events
time frame: Measured for approximately 2 months
Physical Examinations
time frame: Measured for approximately 2 months
Single Leg Standing Balance Test
time frame: Measured for approximately 2 months
Knee Proprioceptive Test
time frame: Measured for approximately 2 months
Knee Extensor/Flexor Force Test
time frame: Measured for approximately 2 months
Knee Range of Motion (ROM)
time frame: Measured for approximately 2 months
Step Test
time frame: Measured for approximately 2 months
Functional Reach Test
time frame: Measured for approximately 2 months
Timed Up and Go Test
time frame: Measured for approximately 2 months
Changes in quality of life
time frame: Measured for approximately 2 months
Neurological Examinations
time frame: Measured for approximately 2 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title 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.
Principal investigator Timothy Wagner, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital.