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NCT Number: NCT01404052

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

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.

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Key information

Conditions

Chronic Pain Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

STUDY ELIGIBILITY CRITERIA

Inclusion criteria

  • Providing informed consent to participate in the study
  • 18 to 64 years old
  • 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)
  • Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
  • Must have the ability to feel pain as self reported

Exclusion criteria

  • Subject is pregnant.
  • Contraindications to tDCS:
  • metal in the head
  • implanted brain medical devices
  • Contraindications to TUS:
  • metal in the head
  • implanted brain medical devices
  • History of alcohol or drug abuse within the past 6 months as self reported
  • Use of carbamazepine within the past 6 months as self reported.
  • Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)
  • History of neurological disorders as self reported.
  • History of unexplained fainting spells as self reported,
  • History of head injury resulting in more than a momentary loss of consciousness as self reported
  • History of neurosurgery as self reported

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Subjects will be randomized to undergo either 5 sessions of active tDCS stimulation, or 5 sessions of sham tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2 and an 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. Active stimulation will last for 20 minutes, while sham stimulation will only last for 30 seconds, mimicking the sensations during active stimulation.

Other names: low intensity 1x1 direct current stimulator

Primary outcomes

  1. Changes in pain scale

    Time frame: 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 outcomes

  1. Changes in cutaneous allodynia/hyperalgesia

    Time frame: 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)

  2. Assessment of hemodynamic changes with transcranial ultrasound

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Collaborators

  • Highland Instruments, Inc.

Registry information

Official study title

Effects of Transcranial Direct Current Stimulation and Transcranial Ultrasound on the Perception of Pain Due to Osteoarthritis of the Knee

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 27, 2011
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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