Osteoarthritis, KneeNCT03117231
Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis
A study testing Active Transcranial Direct Current Stimulation (tDCS) in people with Osteoarthritis, Knee and Chronic Pain, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Chronic Pain
- What is being tested?
- Active Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Mar 2018to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Osteoarthritis, Knee, Chronic Pain
- Being tested
- Active Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS)
- Keywords
- osteoarthritis, elderly, musculoskeletal pain, transcranial direct current stimulation
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain, Osteoarthritis, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Direct Current Stimulation (tDCS)Device
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.
Sham Transcranial Direct Current Stimulation (tDCS)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes. Receives: Device: Active Transcranial Direct Current Stimulation (tDCS) |
| Sham tDCS | Sham comparator | Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes. Receives: Device: Sham Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Measured at baseline and up to 60 days after the end of stimulation
Secondary outcomes (13)
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.
Measured: Measured at baseline, 15, 30 and 60 days after the of stimulation
Changes in Physical Function as measured through Lequesne Index
The investigators will use the Lequesne Index to assess changes in functional capacity.
Measured: Measured at baseline, 15, 30, and 60 days after the end of stimulation
Changes in Patient Global Assessment
Modifications in the patient global assessment will be evaluated by measuring changes in the Visual Analogue Scale (VAS).
Measured: Measured at baseline, 15, 30 and 60 after the end of stimulation
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.
Measured: Measured at baseline, 15, 30 and 60 days after the end of stimulation
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.
Measured: Up to 60 days after the end of stimulation
Changes in Mood
The safety of tDCS will be monitored by measuring changes in the Visual Analog Mood Scale.
Measured: Up to 60 days after the end of stimulation
Changes in cognition
The safety of tDCS will be monitored by measuring changes in the MMSE.
Measured: Up to 60 days after the end of stimulation
One leg standing balance test
The investigators will analyse how long time the subject can stay stand on one foot to analise those balance.
Measured: Measured at baseline, 15, 30 and 60 days after the end of stimulation
Timed Up and Go Test
The investigators will measure the walking speed of the subjects.
Measured: Measured at baseline, 15, 30 and 60 days after the end of stimulation
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.
Measured: Measured at baseline, 15, 30 and 60 days after the end of stimulation
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.
Measured: Measured at baseline, 15, 30 and 60 days after the end of stimulation
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.
Measured: Measured at baseline, 15, 30 and 60 days after the end of stimulation
Descending Noxious Inhibitory Control (DNIC)
The investigators will monitore the central modulation of pain.
Measured: Measured at baseline, 15, 30 and 60 days after the end of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start15 Mar 2018
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Spaulding Rehabilitation Hospital
- Responsible party
- Principal investigator, Daniela Regina Brandão Tavares, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117231
- Sponsor's protocol ID
- Tavares1
- Status last verified
- Sep 2019
- First submitted
- 6 Apr 2017
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33684598Tavares 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.
PubMed 30373731
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03117231
- Acronym / sponsor ID
- Tavares1
- Conditions
- Osteoarthritis, Knee, Chronic Pain
- Keywords
- osteoarthritis, elderly, musculoskeletal pain, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Spaulding Rehabilitation Hospital
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active Transcranial Direct Current Stimulation (tDCS)Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes. |
| Sham tDCS | Sham comparator | Device: Sham Transcranial Direct Current Stimulation (tDCS)Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Transcranial Direct Current Stimulation (tDCS)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. | Device | Active tDCS |
| Sham Transcranial Direct Current Stimulation (tDCS)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 | Device | Sham tDCS |
Primary outcome
Changes in Pain Scale
Time frame: Measured at baseline and up to 60 days after the end of stimulation
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)
13 secondary outcomes
Changes in Quality of Life
Time frame: Measured at baseline, 15, 30 and 60 days after the of stimulation
Changes in Physical Function as measured through Lequesne Index
Time frame: Measured at baseline, 15, 30, and 60 days after the end of stimulation
Changes in Patient Global Assessment
Time frame: Measured at baseline, 15, 30 and 60 after the end of stimulation
Changes in Physical Function as measured through Western Ontário and McMaster Universities Osteoarthritis Index
Time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
Adverse Events
Time frame: Up to 60 days after the end of stimulation
Changes in Mood
Time frame: Up to 60 days after the end of stimulation
Changes in cognition
Time frame: Up to 60 days after the end of stimulation
One leg standing balance test
Time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
Timed Up and Go Test
Time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
Changes Pain Pressure Threshold (PPT)
Time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
Changes in mechanical detection threshold as measured through Von-Frey monofilaments
Time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
Changes in mechanical pain threshold as measured through Von-Frey monofilaments
Time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
Descending Noxious Inhibitory Control (DNIC)
Time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Derived from this study: PubMed 33684598Tavares 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.
- Derived from this study: PubMed 30373731Tavares 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial Direct Current Stimulation (tDCS) in people with Osteoarthritis, Knee and Chronic Pain, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain Scale (time frame: Measured at baseline and up to 60 days after the end of stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117231, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.