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

Mass General Brigham logo

Mass General Brigham

Status

Active, not recruiting

Conditions

Osteoarthritis
Chronic Pain

Treatments

Device: active low-intensity transcranial electrical stimulation/active transcranial ultrasound
Device: Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02723929
2016P000486

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

64 participants in 2 patient groups

Active Electrical Stim/Active Ultrasound
Experimental group
Description:
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Treatment:
Device: active low-intensity transcranial electrical stimulation/active transcranial ultrasound
Sham Electrical Stim/Sham Ultrasound
Sham Comparator group
Description:
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Treatment:
Device: Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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