Clinical trial NCT02723929: 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: ACTIVE_NOT_RECRUITING
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: 2016-03-31
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: tDCS and tUS
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 knee as self-reported.
4. Existing knee pain of at least 3 on a 0-10 VAS scale on average over the past 6 months.
5. Pain of at least 3 on a 0-10 VAS scale on average over the week prior to the first stimulation session.
6. 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.
7. 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 as Measured by VAS
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Average Daily Dose of Acetaminophen Equivalent
timeFrame: 8 weeks
measure: Changes in Pain Scale as Measured by VAS
timeFrame: Baseline and 4 weeks post-stimulation
measure: Percentage Change in Diffuse Noxious Inhibitory Controls (DNIC) From Baseline
timeFrame: Baseline and 8 weeks
measure: Percentage Change From Baseline in the Single Leg Standing Balance Test
timeFrame: Baseline and 8 weeks
measure: Percentage Change From Baseline in the Step Test
timeFrame: Baseline and 8 weeks
measure: Percentage Change in Functional Reach Test From Baseline
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Network Research Institute
state: Massachusetts
Study officials:
References: