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

Primary Purpose

Chronic Pain, Osteoarthritis

Status
Active
Phase
Locations
United States
Study Type
Interventional
Intervention
active low-intensity transcranial electrical stimulation/active transcranial ultrasound
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring transcranial direct current stimulation, transcranial ultrasound, non-invasive brain stimulation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Spaulding Rehabilitation Network Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Electrical Stim/Active Ultrasound

Sham Electrical Stim/Sham Ultrasound

Arm Description

Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.

Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.

Outcomes

Primary Outcome Measures

Changes in Pain Scale as Measured by VAS
Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain and is reported following the full course of therapy. Since we are using a difference, smaller values (negative) represent a better outcome

Secondary Outcome Measures

Average Daily Dose of Acetaminophen Equivalent
Analgesic use (average daily dose of acetaminophen equivalent)
Changes in Pain Scale as Measured by VAS
Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain. Since we are using a difference, smaller values (negative) represent a better outcome.
Percentage Change in Diffuse Noxious Inhibitory Controls (DNIC) From Baseline
This measures the endogenous pain modulatory pathway. This study will evaluate DNIC in pain patients using pressure as the test stimulus, and cold water as the conditioning stimulus. DNIC will be induced approximately 1-min later by having subjects immerse their hand into a water bath maintained at 10-12˚C for approximately 1 min. Parallel to the last 30s of DNIC conditioning (cold water immersion), the pressure test stimulus will be reapplied. DNIC response will be calculated as the difference between the average of pain ratings from the test stimulus minus the average of pain ratings during the conditioned stimulus. Larger percentage change means a better outcome.
Percentage Change From Baseline in the Single Leg Standing Balance Test
We will record the time (seconds) for which a subject is able to stand unsupported on one foot while looking straight ahead with hands on hips. Larger percentage change means a better outcome.
Percentage Change From Baseline in the Step Test
The subject was asked to stand unsupported with their feet parallel to each other in front of a step. We assessed the number of times the participant could place their foot up onto the step and return it to the floor over a 15-sec interval. Larger percentage change means a better outcome.
Percentage Change in Functional Reach Test From Baseline
Subject will be instructed to stand next to, but not touch the wall, and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. Smoothness of wrist movement is assessed as the subject was asked to outstretch their arm in a maximal forward reach, while maintaining a fixed base of support. Smoothness is dimensionless and is calculated as mean speed divided by peak speed. Larger percentage change means a better outcome.

Full Information

First Posted
February 26, 2016
Last Updated
August 22, 2022
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Highland Instruments, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02723929
Brief Title
Effects of tDCS and tUS on Pain Perception in OA of the Knee
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
July 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Highland Instruments, Inc.

4. Oversight

Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Osteoarthritis
Keywords
transcranial direct current stimulation, transcranial ultrasound, non-invasive brain stimulation

7. Study Design

Primary Purpose
Treatment
Interventional Study Model
Parallel Assignment
Model Description
tDCS and tUS
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Electrical Stim/Active Ultrasound
Arm Type
Experimental
Arm Description
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Arm Title
Sham Electrical Stim/Sham Ultrasound
Arm Type
Sham Comparator
Arm Description
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Intervention Type
Device
Intervention Name(s)
active low-intensity transcranial electrical stimulation/active transcranial ultrasound
Intervention Description
Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.
Intervention Type
Device
Intervention Name(s)
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound
Intervention Description
Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
Primary Outcome Measure Information:
Title
Changes in Pain Scale as Measured by VAS
Description
Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain and is reported following the full course of therapy. Since we are using a difference, smaller values (negative) represent a better outcome
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Average Daily Dose of Acetaminophen Equivalent
Description
Analgesic use (average daily dose of acetaminophen equivalent)
Time Frame
8 weeks
Title
Changes in Pain Scale as Measured by VAS
Description
Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain. Since we are using a difference, smaller values (negative) represent a better outcome.
Time Frame
Baseline and 4 weeks post-stimulation
Title
Percentage Change in Diffuse Noxious Inhibitory Controls (DNIC) From Baseline
Description
This measures the endogenous pain modulatory pathway. This study will evaluate DNIC in pain patients using pressure as the test stimulus, and cold water as the conditioning stimulus. DNIC will be induced approximately 1-min later by having subjects immerse their hand into a water bath maintained at 10-12˚C for approximately 1 min. Parallel to the last 30s of DNIC conditioning (cold water immersion), the pressure test stimulus will be reapplied. DNIC response will be calculated as the difference between the average of pain ratings from the test stimulus minus the average of pain ratings during the conditioned stimulus. Larger percentage change means a better outcome.
Time Frame
Baseline and 8 weeks
Title
Percentage Change From Baseline in the Single Leg Standing Balance Test
Description
We will record the time (seconds) for which a subject is able to stand unsupported on one foot while looking straight ahead with hands on hips. Larger percentage change means a better outcome.
Time Frame
Baseline and 8 weeks
Title
Percentage Change From Baseline in the Step Test
Description
The subject was asked to stand unsupported with their feet parallel to each other in front of a step. We assessed the number of times the participant could place their foot up onto the step and return it to the floor over a 15-sec interval. Larger percentage change means a better outcome.
Time Frame
Baseline and 8 weeks
Title
Percentage Change in Functional Reach Test From Baseline
Description
Subject will be instructed to stand next to, but not touch the wall, and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. Smoothness of wrist movement is assessed as the subject was asked to outstretch their arm in a maximal forward reach, while maintaining a fixed base of support. Smoothness is dimensionless and is calculated as mean speed divided by peak speed. Larger percentage change means a better outcome.
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 knee as self-reported. Existing knee pain of at least 3 on a 0-10 VAS scale on average over the past 6 months. Pain of at least 3 on a 0-10 VAS scale on average over the week prior to the first stimulation session. 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.
Facility Information:
Facility Name
Spaulding Rehabilitation Network Research Institute
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

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

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