Clinical trial NCT02330315: Effects of tDCS and tUS on Pain Perception in OA of the Knee
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Osteoarthritis
Keywords: transcranial direct current stimulation
transcranial ultrasound
non-invasive brain stimulation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Highland Instruments, Inc.
First posted: 2015-01-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: Changes in Pain Scale
timeFrame: Measured for approximately 2 months
Secondary outcomes:
measure: Changes in Mood
timeFrame: Measured for approximately 2 months
measure: Changes in cognition, attention, and focus
timeFrame: Measured for approximately 2 months
measure: Adverse Events
timeFrame: Measured for approximately 2 months
measure: Physical Examinations
timeFrame: Measured for approximately 2 months
measure: Single Leg Standing Balance Test
timeFrame: Measured for approximately 2 months
measure: Knee Proprioceptive Test
timeFrame: Measured for approximately 2 months
measure: Knee Extensor/Flexor Force Test
timeFrame: Measured for approximately 2 months
measure: Knee Range of Motion (ROM)
timeFrame: Measured for approximately 2 months
measure: Step Test
timeFrame: Measured for approximately 2 months
measure: Functional Reach Test
timeFrame: Measured for approximately 2 months
measure: Timed Up and Go Test
timeFrame: Measured for approximately 2 months
measure: Changes in quality of life
timeFrame: Measured for approximately 2 months
measure: Neurological Examinations
timeFrame: Measured for approximately 2 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Highland Instruments, Inc.
name: Timothy Wagner, PhD
role: PRINCIPAL_INVESTIGATOR
References: