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NCT Number: NCT02330315

Effects of tDCS and tUS on Pain Perception in OA of the Knee

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.

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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–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to provide informed consent to participate in the study.
  • Subjects between 18-85 years old.
  • 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.

  • Existing knee pain in the past 6 months of at least 3 on a 0-10 VAS scale on average.
  • 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.
  • Having the ability to feel pain as self-reported

Exclusion criteria

  • Pregnancy or trying to become pregnant in the next 6 months.
  • History of alcohol or drug abuse within the past 6 months as self-reported.
  • Contraindications to transcranial brain stimulation or TUS, i.e. implanted brain medical devices or implanted brain metallic devices.
  • Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
  • Epilepsy.
  • 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 unexplained fainting spells as self-reported.
  • Head injury resulting in more than a momentary loss of consciousness
  • History of neurosurgery as self-reported.

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

Subjects will receive 20 minutes of either active or sham tDCS at 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. In the sham group, the tDCS device will not be active for the full 20 minutes.

Transcranial Ultrasound (TUS)

Device

Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

Primary outcomes

  1. Changes in Pain Scale

    Time frame: Measured for approximately 2 months

    Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to 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 osteoarthritis knee pain. The investigators will also look at changes in the Von Frey assessment and pain pressure threshold (PPT).

Secondary outcomes

  1. Changes in Mood

    Time frame: Measured for approximately 2 months

    The investigators will measure safety of tDCS and TUS by measuring changes in the Visual Analog Mood Scale (VAMS).

  2. Changes in cognition, attention, and focus

    Time frame: Measured for approximately 2 months

    The investigators will monitor the safety of tDCS and TUS in subjects by measuring any changes in cognition, attention, and focus with the California Computerized Assessment Package (CalCap) mini.

  3. Adverse Events

    Time frame: Measured for approximately 2 months

    At each session, subjects will complete a questionnaire to evaluate potential adverse effects of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale. The scale will also be administered at the follow-ups.

  4. Physical Examinations

    Time frame: Measured for approximately 2 months

    Trained study staff will perform standard physical examinations at several points throughout the study to ensure subject safety. Baseline findings will be compared to the findings observed at the various time points throughout the study to ensure there are no significant changes that may be study related.

  5. Single Leg Standing Balance Test

    Time frame: Measured for approximately 2 months

    The investigators will measure how long the subject can stand on one foot in order to measure any changes in balance

  6. Knee Proprioceptive Test

    Time frame: Measured for approximately 2 months

    Proprioceptive acuity will be assessed by the ability to reproduce passive positioning of the leg with eyes closed.

  7. Knee Extensor/Flexor Force Test

    Time frame: Measured for approximately 2 months

    The investigators will measure whether there are changes in knee extension/flexion abilities.

  8. Knee Range of Motion (ROM)

    Time frame: Measured for approximately 2 months

    The knee range of motion (flexion/extension angle) will be recorded with an electrogoniometer and motion analysis capture system.

  9. Step Test

    Time frame: Measured for approximately 2 months

    Subject will be asked to stand unsupported with the feet parallel to each other and a block 5 cm directly in front of them. Subject will then be advised which leg is the stepping leg and asked to place the whole foot onto the block, then return it fully down to the floor. This procedure will be repeated as fast as possible.

  10. Functional Reach Test

    Time frame: Measured for approximately 2 months

    The investigators will measure changes in subjects ability to complete the functional reach test across the duration of study.

  11. Timed Up and Go Test

    Time frame: Measured for approximately 2 months

    The investigators will measure if there are changes in the walking speed of the subject from the beginning of the study to the end.

  12. Changes in quality of life

    Time frame: Measured for approximately 2 months

    The investigators will use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in quality of life and physical functioning.

  13. Neurological Examinations

    Time frame: Measured for approximately 2 months

    Trained study staff will perform standard neurological examinations at several points throughout the study to ensure subject safety. Baseline findings will be compared to the findings observed at the various time points throughout the study to ensure there are no significant changes that may be study related.

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Collaborators

  • Highland Instruments, Inc.

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2015
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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