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Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active Transcranial Direct Current Stimulation (tDCS)
Sham Transcranial Direct Current Stimulation (tDCS)
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, elderly, musculoskeletal pain, transcranial direct current stimulation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals > 60 years old, of both genders.
  • Diagnosis of primary knee osteoarthritis with chronic pain self-reported.
  • Be able to sign the informed consent to participate in the study.
  • Chronic pain (over the past 6 months) of at least 4 on a 0-10 VAS scale on average.
  • Reduction on VAS (visual analogic scale) during CPM (conditioned pain modulation) < 10%

Exclusion Criteria:

  • Contraindications to transcranial brain stimulation, i.e. implanted brain medical devices or implanted brain metallic devices.
  • Severe acute or chronic decompensated disease.
  • Cognitive and behavioral impairment.
  • Epilepsy.
  • History of fractures in the lower limbs and/or spine in the last 6 months.
  • Use of carbamazepine within the past 6 months as self-reported.
  • Severe depression (with a score of >30 in the Beck Depression Inventory)
  • History of syncope.
  • Traumatic brain injury with residual neurological deficits.
  • History of alcohol abuse within the past 6 months as self-reported.

Sites / Locations

  • Daniela Tavares

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.

Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.

Outcomes

Primary Outcome Measures

Changes in Pain Scale
Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with chronic pain due to knee osteoarthritis, as measured by changes in the Brief Pain Inventory (BPI)

Secondary Outcome Measures

Changes in Quality of Life
The investigators will use the 12-Item Short Form Health Survey (SF-12) to assess changes in quality of life.
Changes in Physical Function as measured through Lequesne Index
The investigators will use the Lequesne Index to assess changes in functional capacity.
Changes in Patient Global Assessment
Modifications in the patient global assessment will be evaluated by measuring changes in the Visual Analogue Scale (VAS).
Changes in Physical Function as measured through Western Ontário and McMaster Universities Osteoarthritis Index
The investigators will use the Western Ontário and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in functional capacity.
Adverse Events
Subjects will complete a questionnaire, after each session, to assess potential adverse events of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale.
Changes in Mood
The safety of tDCS will be monitored by measuring changes in the Visual Analog Mood Scale.
Changes in cognition
The safety of tDCS will be monitored by measuring changes in the MMSE.
One leg standing balance test
The investigators will analyse how long time the subject can stay stand on one foot to analise those balance.
Timed Up and Go Test
The investigators will measure the walking speed of the subjects.
Changes Pain Pressure Threshold (PPT)
Changes in the pain pressure threshold will be analyzed in order to determine whether anodal transcranial direct current stimulation is effective in increasing the pain pressure threshold in subjects with osteoarthritis knee pain.
Changes in mechanical detection threshold as measured through Von-Frey monofilaments
Changes in the mechanical detection threshold (MDT) will be measured through calibrated Von-Frey monofilaments in order to determine whether anodal transcranial direct current stimulation is effective in increasing the mechanical detection threshold of subjects with osteoarthritis knee pain.
Changes in mechanical pain threshold as measured through Von-Frey monofilaments
Changes in the mechanical pain threshold (MDT) will be measured through calibrated Von-Frey monofilaments in order to determine whether anodal transcranial direct current stimulation is effective in increasing the mechanical pain threshold of subjects with osteoarthritis knee pain.
Descending Noxious Inhibitory Control (DNIC)
The investigators will monitore the central modulation of pain.

Full Information

First Posted
April 6, 2017
Last Updated
September 6, 2019
Sponsor
Federal University of São Paulo
Collaborators
Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03117231
Brief Title
Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis
Official Title
Effects of Transcranial Direct Current Stimulation (tDCS) on Knee Osteoarthritis Pain in Elderly Subjects With Defective Endogenous Pain-Inhibitory System: Protocol for a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate if anodal tDCS stimulation over M1 may decrease chronic knee OA pain in elderly subjects with defective CPM. In addition, this trial will help to investigate the role of central sensitization in knee OA and evaluate how tDCS stimulation may affect it.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Chronic Pain
Keywords
osteoarthritis, elderly, musculoskeletal pain, transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.
Intervention Type
Device
Intervention Name(s)
Active Transcranial Direct Current Stimulation (tDCS)
Intervention Description
Subjects will undergo 15 sessions of tDCS stimulation, 1x per day at 20 minutes per session, of up to 2mA. During active stimulation, the current will be active for the full 20 minutes.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation (tDCS)
Intervention Description
Subjects will undergo 15 sessions of tDCS stimulation, 1x per day at 20 minutes per session, of up to 2mA. However, during sham stimulation (placebo) the current will not be active for the full 20 minutes
Primary Outcome Measure Information:
Title
Changes in Pain Scale
Description
Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with chronic pain due to knee osteoarthritis, as measured by changes in the Brief Pain Inventory (BPI)
Time Frame
Measured at baseline and up to 60 days after the end of stimulation
Secondary Outcome Measure Information:
Title
Changes in Quality of Life
Description
The investigators will use the 12-Item Short Form Health Survey (SF-12) to assess changes in quality of life.
Time Frame
Measured at baseline, 15, 30 and 60 days after the of stimulation
Title
Changes in Physical Function as measured through Lequesne Index
Description
The investigators will use the Lequesne Index to assess changes in functional capacity.
Time Frame
Measured at baseline, 15, 30, and 60 days after the end of stimulation
Title
Changes in Patient Global Assessment
Description
Modifications in the patient global assessment will be evaluated by measuring changes in the Visual Analogue Scale (VAS).
Time Frame
Measured at baseline, 15, 30 and 60 after the end of stimulation
Title
Changes in Physical Function as measured through Western Ontário and McMaster Universities Osteoarthritis Index
Description
The investigators will use the Western Ontário and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in functional capacity.
Time Frame
Measured at baseline, 15, 30 and 60 days after the end of stimulation
Title
Adverse Events
Description
Subjects will complete a questionnaire, after each session, to assess potential adverse events of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale.
Time Frame
Up to 60 days after the end of stimulation
Title
Changes in Mood
Description
The safety of tDCS will be monitored by measuring changes in the Visual Analog Mood Scale.
Time Frame
Up to 60 days after the end of stimulation
Title
Changes in cognition
Description
The safety of tDCS will be monitored by measuring changes in the MMSE.
Time Frame
Up to 60 days after the end of stimulation
Title
One leg standing balance test
Description
The investigators will analyse how long time the subject can stay stand on one foot to analise those balance.
Time Frame
Measured at baseline, 15, 30 and 60 days after the end of stimulation
Title
Timed Up and Go Test
Description
The investigators will measure the walking speed of the subjects.
Time Frame
Measured at baseline, 15, 30 and 60 days after the end of stimulation
Title
Changes Pain Pressure Threshold (PPT)
Description
Changes in the pain pressure threshold will be analyzed in order to determine whether anodal transcranial direct current stimulation is effective in increasing the pain pressure threshold in subjects with osteoarthritis knee pain.
Time Frame
Measured at baseline, 15, 30 and 60 days after the end of stimulation
Title
Changes in mechanical detection threshold as measured through Von-Frey monofilaments
Description
Changes in the mechanical detection threshold (MDT) will be measured through calibrated Von-Frey monofilaments in order to determine whether anodal transcranial direct current stimulation is effective in increasing the mechanical detection threshold of subjects with osteoarthritis knee pain.
Time Frame
Measured at baseline, 15, 30 and 60 days after the end of stimulation
Title
Changes in mechanical pain threshold as measured through Von-Frey monofilaments
Description
Changes in the mechanical pain threshold (MDT) will be measured through calibrated Von-Frey monofilaments in order to determine whether anodal transcranial direct current stimulation is effective in increasing the mechanical pain threshold of subjects with osteoarthritis knee pain.
Time Frame
Measured at baseline, 15, 30 and 60 days after the end of stimulation
Title
Descending Noxious Inhibitory Control (DNIC)
Description
The investigators will monitore the central modulation of pain.
Time Frame
Measured at baseline, 15, 30 and 60 days after the end of stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals > 60 years old, of both genders. Diagnosis of primary knee osteoarthritis with chronic pain self-reported. Be able to sign the informed consent to participate in the study. Chronic pain (over the past 6 months) of at least 4 on a 0-10 VAS scale on average. Reduction on VAS (visual analogic scale) during CPM (conditioned pain modulation) < 10% Exclusion Criteria: Contraindications to transcranial brain stimulation, i.e. implanted brain medical devices or implanted brain metallic devices. Severe acute or chronic decompensated disease. Cognitive and behavioral impairment. Epilepsy. History of fractures in the lower limbs and/or spine in the last 6 months. Use of carbamazepine within the past 6 months as self-reported. Severe depression (with a score of >30 in the Beck Depression Inventory) History of syncope. Traumatic brain injury with residual neurological deficits. History of alcohol abuse within the past 6 months as self-reported.
Facility Information:
Facility Name
Daniela Tavares
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
33684598
Citation
Tavares DRB, Okazaki JEF, Santana MVA, Pinto ACPN, Tutiya KK, Gazoni FM, Pinto CB, Santos FC, Fregni F, Trevisani VFM. Motor cortex transcranial direct current stimulation effects on knee osteoarthritis pain in elderly subjects with dysfunctional descending pain inhibitory system: A randomized controlled trial. Brain Stimul. 2021 May-Jun;14(3):477-487. doi: 10.1016/j.brs.2021.02.018. Epub 2021 Mar 5.
Results Reference
derived
PubMed Identifier
30373731
Citation
Tavares DRB, Okazaki JEF, Rocha AP, Santana MVA, Pinto ACPN, Civile VT, Santos FC, Fregni F, Trevisani VFM. Effects of Transcranial Direct Current Stimulation on Knee Osteoarthritis Pain in Elderly Subjects With Defective Endogenous Pain-Inhibitory Systems: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 29;7(10):e11660. doi: 10.2196/11660.
Results Reference
derived

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Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis

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