Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound on Osteoarthritis Pain of the Knee

Mass General Brigham

Status: Completed

Conditions: Osteoarthritis; Chronic Pain

Treatments: Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01404052

2010-p-001977

Details and patient eligibility

About

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain associated 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. Before, during and after stimulation, the investigators will measure and assess changes intracranial blood flow with transcranial ultrasound.

Enrollment: 38 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

STUDY ELIGIBILITY CRITERIA

Inclusion Criteria:

1. Providing informed consent to participate in the study
2. 18 to 64 years old
3. Having chronic osteoarthritis knee pain in either knee (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
4. Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
5. Must have the ability to feel pain as self reported

Exclusion Criteria:

1. Subject is pregnant.

2. Contraindications to tDCS:

   • metal in the head
   • implanted brain medical devices

3. Contraindications to TUS:

   • metal in the head
   • implanted brain medical devices

4. History of alcohol or drug abuse within the past 6 months as self reported

5. Use of carbamazepine within the past 6 months as self reported.

6. Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)

7. History of neurological disorders as self reported.

8. History of unexplained fainting spells as self reported,

9. History of head injury resulting in more than a momentary loss of consciousness as self reported

10. History of neurosurgery as self reported

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Active tDCS + transcranial ultrasound

Experimental group

Description:

Subjects will undergo 20 minutes active tDCS in conjunction with transcranial ultrasound measurements.

Treatment:

Device: Transcranial Direct Current Stimulation

Sham tDCS + transcranial ultrasound

Sham Comparator group

Description:

Subjects will receive sham tDCS in conjunction with transcranial ultrasound measurements.

Treatment:

Device: Transcranial Direct Current Stimulation