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

Not Applicable

Completed

• Conditions: Chronic Pain; Osteoarthritis
• Interventions: Device: Transcranial Direct Current Stimulation

• Registration Number: NCT01404052
• Lead Sponsor: Spaulding Rehabilitation Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Primary Completion: 2014-07-30
• Study Completion: 2014-07-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS + transcranial ultrasound	Transcranial Direct Current Stimulation	Subjects will receive sham tDCS in conjunction with transcranial ultrasound measurements.
Active tDCS + transcranial ultrasound	Transcranial Direct Current Stimulation	Subjects will undergo 20 minutes active tDCS in conjunction with transcranial ultrasound measurements.

Primary Outcome Measures

Name	Time	Method
Changes in pain scale	Measured for approximately 2 months	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 chronic osteoarthritis pain, as measured by changes in the Visual Analogue Scale (VAS) for pain. VAS will be measured immediately before the tDCS stimulation sessions, and immediately after the tDCS stimulation sessions for the subject's duration in the trial. VAS will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)

Secondary Outcome Measures

Name	Time	Method
Changes in cutaneous allodynia/hyperalgesia	Measured for approximately 2 months	To investigate whether stimulation with active anodal tDCS with ultrasound (applied in a diagnostic mode) alters the phenomenon of central sensitization, as indexed by cutaneous allodynia and hyperalgesia, measured by the pain perception threshold as compared with sham tDCS. Pain measurements will be measured immediately before the tDCS stimulation sessions, and immediately after for the subject's duration in the trial. Pain measurements will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)
Assessment of hemodynamic changes with transcranial ultrasound	Measured for approximately 2 months	To investigate hemodynamic changes in the brain that may occur due to tDCS as measured by transcranial ultrasound. Blood flow measured by TUS will be measured immediately before during and after the tDCS stimulation sessions, for the subject's duration in the trial. Blood flow measured by TUS will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States