Knee OsteoarthritisNCT02512393
Transcranial Direct Current Stimulation in Older Persons With Knee Pain (Knee Pain and tDCS): Randomized Pilot Study
A study testing Active tDCS in people with Knee Osteoarthritis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this research is to study the effects of Transcranial Direct Current Stimulation (tDCS) on clinical pain, mobility disability, and pain sensitivity to gain a better understanding of the factors that cause pain and disability in people with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- they have self-reported unilateral or bilateral knee OA pain according to American College of Rheumatology criteria
- they can understand, speak and read English
- they are able to walk for 6-minutes
- they are willing to be randomized to either the intervention or control group
- they are available for five consecutive daily sessions and for a follow-up phone interview each week for three weeks post-stimulation sessions
- they have no plan to change medication regimens for pain throughout the trial
- they are willing and able to provide written informed consent
Who cannot join
- knee replacement or non-arthroscopic surgery to the affected knee
- serious medical illness, such as uncontrolled hypertension (i.e., Systolic Blood Pressure/Diastolic Blood Pressure of ≥ 150/95), congestive heart failure, pacemaker, or history of acute myocardial infarction
- peripheral neuropathy
- systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
- alcohol/substance abuse
- cognitive impairment (i.e., Mini-Mental Status Exam score ≤ 23)
Show all 9Show fewer
- history of brain surgery, tumor, seizure, stroke, or intracranial metal implantation
- pregnancy or lactation for females
- hospitalization within the preceding year due to psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Transcranial Direct Current Stimulation in Older Persons With Knee Pain: Randomized Pilot Study
The purpose of this research is to study the effects of Transcranial Direct Current Stimulation (tDCS) on clinical pain, mobility disability, and pain sensitivity to gain a better understanding of the factors that cause pain and disability in people with knee osteoarthritis (OA). In particular, people from different ethnic and racial groups may experience OA pain differently which is why the focus will be on older Asian Americans and non-Hispanic whites. It is important to find a reason for such difference so that a better treatment can be found for all OA patients. In addition, the research study will examine if there is any ethnic differences in pain and mobility disability. The investigator hypothesize that Asian Americans will report greater pain and mobility disability than non-Hispanic whites, and that active tDCS will result in improvement in pain and disability compared to sham tDCS.
Read the detailed description
If you participate in the study, the following will happen:
Randomized into one of two groups. Which will either receive the full length session of brain stimulation or a much shorter session of brain stimulation. The shorter version of stimulation looks like and is performed in the same way as the longer electrical stimulation session, but stimulation is stopped before it can have much of an effect on the brain. You will not know which group you have been assigned to while participating in the research, but you may find out at the completion of the research study.
X-Rays will be done on both knees while standing up.
Questionnaires about arthritis pain you are having, your thoughts and feelings about it, and any stress that you may have experienced.
Walking Test will be performed on a flat surface for 6 minutes at a fast pace without help from an assistive device (cane or walker) or another person.
Assessment of Physical Performance requires walking at short distance (about 13 feet), stand up from a chair 5 times without using your arms, and stand in 3 different positions while keeping your balance.
Assessment of Sensitivity to Heat. Heat pain sensitivity will be tested using a commercially available thermal sensory testing machine (Medoc, Inc.) used widely in clinical settings. This machine has a small (about 1 inch by 1 inch) square piece that is used to apply heat to the skin. Heat will be applied to the knees and arms. The amount of heat is controlled by a computer. One or more of the following types of heat stimuli will be delivered: 1) a slowly increasing heat that can be stopped by pressing a button when it becomes warm, painful, or intolerable; 2) a series of 5-10 heat pulses that are brief (less than 2 seconds in duration), and rate how painful each heat pulse feels; and 3) a few longer heat pulses (15-30 seconds) at different temperatures to rate how painful each heat pulse feels. The procedures can be stop at any time.
Assessment of Sensitivity to Pressure will be done using a handheld device with a small rubber tip to apply pressure to the knee, thigh, and shoulder.
Assessment of Sensitivity to Mechanical Stimulation will be done using a handheld probe that has a small nylon tip to tap both the knee and hand.
Blood Draw: Blood will be taken at the baseline visit and at the last visit.
Brain Stimulation: The stimulation technique called transcranial direct current stimulation (tDCS) and it involves placing two sponge-like electrodes on your head and delivering a very weak electrical current to your scalp, which is generated by a 9 volt battery.
In addition, weekly phone calls will be done for the next 3 weeks.
- Conditions
- Knee Osteoarthritis
- Being tested
- Active tDCS, Sham tDCS
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Also called Transcranial Direct Current Stimulation
This group will receive tDCS with a constant current of 2 mA intensity will be applied for 20 minutes once a day for five consecutive days using a pair of thick (0.3 cm) rectangular surface sponge electrodes (5 cm x 7 cm) saturated with 10 mL of saline solution. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
Sham tDCSDevice
This group will receive tDCS with a constant current of 2 mA intensity will be applied for 30 seconds once a day for five consecutive days using a pair of thick (0.3 cm) rectangular surface sponge electrodes (5 cm x 7 cm) saturated with 10 mL of saline solution. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage). In addition, the following test will performed: X-Rays, Walking Test, Assessment of Physical Performance, Assessment of Sensitivity to Heat, Assessment of Sensitivity to Pressure, Assessment of Sensitivity to Mechanical Stimulation, Assessment of balance, chair stand, and gait speed, Assessment of conditioned pain modulation, and Blood test. Receives: Device: Active tDCS |
| Sham tDCS | Sham comparator | This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage). In addition, the following test will performed: X-Rays, Walking Test, Assessment of Physical Performance, Assessment of Sensitivity to Heat, Assessment of Sensitivity to Pressure, Assessment of Sensitivity to Mechanical Stimulation, Assessment of balance, chair stand, Assessment of conditioned pain modulation, and gait speed and Blood test. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) for Pain
Numeric Rating Scale for pain is an 101-point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.
Measured: baseline
Numeric Rating Scale (NRS) for Pain
Numeric Rating Scale for pain is an 101-point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.
Measured: day 5
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.
Measured: baseline
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.
Measured: day 5
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Measured: baseline
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Measured: day 5
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Measured: baseline
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale
This is a index to rate the activity of pain based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme. The higher the score, the worse the pain.
Measured: day 5
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Measured: baseline
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Measured: day 5
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Measured: baseline
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Measured: day 5
Six-minute Walk Test
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.
Measured: baseline
Six-minute Walk Test
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.
Measured: day 5
Short Physical Performance Battery (SPPB)
This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).
Measured: baseline
Short Physical Performance Battery (SPPB)
This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).
Measured: day 5
Heat Pain Threshold
Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Measured: baseline
Heat Pain Threshold
Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Measured: day 5
Heat Pain Tolerance
Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Measured: baseline
Heat Pain Tolerance
Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Measured: day 5
Pressure Pain Threshold
Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.
Measured: baseline
Pressure Pain Threshold
Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.
Measured: day 5
Punctate Mechanical Pain Sensitivity
Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.
Measured: baseline
Punctate Mechanical Pain Sensitivity
Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.
Measured: day 5
Conditioned Pain Modulation (CPM)
Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.
Measured: baseline
Conditioned Pain Modulation (CPM)
Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.
Measured: day 5
Secondary outcomes (12)
Endorphin Level
Measured: baseline
Endorphin Level
Measured: day 5
Cortisol Level
Measured: baseline
Cortisol Level
Measured: day 5
C-reactive Protein (CRP) Level
Measured: baseline
C-reactive Protein (CRP) Level
Measured: day 5
Tumor Necrosis Factor (TNF) Level
Measured: baseline
Tumor Necrosis Factor (TNF) Level
Measured: day 5
Interleukin 6 (IL-6) Level
Measured: baseline
Interleukin 6 (IL-6) Level
Measured: day 5
Interleukin 10 (IL-10) Level
Measured: baseline
Interleukin 10 (IL-10) Level
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida
- Responsible party
- Principal investigator, Hyochol Ahn, The University of Texas Health Science Center, Houston
- Investigators
- Hyochol Ahn, PhD, ARNP, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512393
- Sponsor's protocol ID
- IRB201500357-2
- Status last verified
- Jun 2017
- First submitted
- 29 Jul 2015
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ahn H, Woods AJ, Kunik ME, Bhattacharjee A, Chen Z, Choi E, Fillingim RB. Efficacy of transcranial direct current stimulation over primary motor cortex (anode) and contralateral supraorbital area (cathode) on clinical pain severity and mobility performance in persons with knee osteoarthritis: An experimenter- and participant-blinded, randomized, sham-controlled pilot clinical study. Brain Stimul. 2017 Sep-Oct;10(5):902-909. doi: 10.1016/j.brs.2017.05.007. Epub 2017 May 19.
PubMed 28566193
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation in Older Persons With Knee Pain: Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT02512393
- Acronym / sponsor ID
- IRB201500357-2
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- University of Florida
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Posted 11 Jul 2017
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 research is to study the effects of Transcranial Direct Current Stimulation (tDCS) on clinical pain, mobility disability, and pain sensitivity to gain a better understanding of the factors that cause pain and disability in people with knee osteoarthritis (OA). In particular, people from different ethnic and racial groups may experience OA pain differently which is why the focus will be on older Asian Americans and non-Hispanic whites. It is important to find a reason for such difference so that a better treatment can be found for all OA patients. In addition, the research study will examine if there is any ethnic differences in pain and mobility disability. The investigator hypothesize that Asian Americans will report greater pain and mobility disability than non-Hispanic whites, and that active tDCS will result in improvement in pain and disability compared to sham tDCS.
Detailed description
If you participate in the study, the following will happen:
Randomized into one of two groups. Which will either receive the full length session of brain stimulation or a much shorter session of brain stimulation. The shorter version of stimulation looks like and is performed in the same way as the longer electrical stimulation session, but stimulation is stopped before it can have much of an effect on the brain. You will not know which group you have been assigned to while participating in the research, but you may find out at the completion of the research study.
X-Rays will be done on both knees while standing up.
Questionnaires about arthritis pain you are having, your thoughts and feelings about it, and any stress that you may have experienced.
Walking Test will be performed on a flat surface for 6 minutes at a fast pace without help from an assistive device (cane or walker) or another person.
Assessment of Physical Performance requires walking at short distance (about 13 feet), stand up from a chair 5 times without using your arms, and stand in 3 different positions while keeping your balance.
Assessment of Sensitivity to Heat. Heat pain sensitivity will be tested using a commercially available thermal sensory testing machine (Medoc, Inc.) used widely in clinical settings. This machine has a small (about 1 inch by 1 inch) square piece that is used to apply heat to the skin. Heat will be applied to the knees and arms. The amount of heat is controlled by a computer. One or more of the following types of heat stimuli will be delivered: 1) a slowly increasing heat that can be stopped by pressing a button when it becomes warm, painful, or intolerable; 2) a series of 5-10 heat pulses that are brief (less than 2 seconds in duration), and rate how painful each heat pulse feels; and 3) a few longer heat pulses (15-30 seconds) at different temperatures to rate how painful each heat pulse feels. The procedures can be stop at any time.
Assessment of Sensitivity to Pressure will be done using a handheld device with a small rubber tip to apply pressure to the knee, thigh, and shoulder.
Assessment of Sensitivity to Mechanical Stimulation will be done using a handheld probe that has a small nylon tip to tap both the knee and hand.
Blood Draw: Blood will be taken at the baseline visit and at the last visit.
Brain Stimulation: The stimulation technique called transcranial direct current stimulation (tDCS) and it involves placing two sponge-like electrodes on your head and delivering a very weak electrical current to your scalp, which is generated by a 9 volt battery.
In addition, weekly phone calls will be done for the next 3 weeks.
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 tDCSThis group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage). In addition, the following test will performed: X-Rays, Walking Test, Assessment of Physical Performance, Assessment of Sensitivity to Heat, Assessment of Sensitivity to Pressure, Assessment of Sensitivity to Mechanical Stimulation, Assessment of balance, chair stand, and gait speed, Assessment of conditioned pain modulation, and Blood test. |
| Sham tDCS | Sham comparator | Device: Sham tDCSThis group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage). In addition, the following test will performed: X-Rays, Walking Test, Assessment of Physical Performance, Assessment of Sensitivity to Heat, Assessment of Sensitivity to Pressure, Assessment of Sensitivity to Mechanical Stimulation, Assessment of balance, chair stand, Assessment of conditioned pain modulation, and gait speed and Blood test. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- they have self-reported unilateral or bilateral knee OA pain according to American College of Rheumatology criteria
- they can understand, speak and read English
- they are able to walk for 6-minutes
- they are willing to be randomized to either the intervention or control group
- they are available for five consecutive daily sessions and for a follow-up phone interview each week for three weeks post-stimulation sessions
Key exclusion criteria (9 listed)
- knee replacement or non-arthroscopic surgery to the affected knee
- serious medical illness, such as uncontrolled hypertension (i.e., Systolic Blood Pressure/Diastolic Blood Pressure of ≥ 150/95), congestive heart failure, pacemaker, or history of acute myocardial infarction
- peripheral neuropathy
- systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
- alcohol/substance abuse
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 tDCSAlso: Transcranial Direct Current StimulationThis group will receive tDCS with a constant current of 2 mA intensity will be applied for 20 minutes once a day for five consecutive days using a pair of thick (0.3 cm) rectangular surface sponge electrodes (5 cm x 7 cm) saturated with 10 mL of saline solution. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage). | Device | Active tDCS |
| Sham tDCSThis group will receive tDCS with a constant current of 2 mA intensity will be applied for 30 seconds once a day for five consecutive days using a pair of thick (0.3 cm) rectangular surface sponge electrodes (5 cm x 7 cm) saturated with 10 mL of saline solution. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage). | Device | Sham tDCS |
Primary outcome
Numeric Rating Scale (NRS) for Pain
Time frame: baseline
Numeric Rating Scale for pain is an 101-point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.
Numeric Rating Scale (NRS) for Pain
Time frame: day 5
Numeric Rating Scale for pain is an 101-point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
Time frame: baseline
This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
Time frame: day 5
This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale
Time frame: baseline
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale
Time frame: day 5
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale
Time frame: baseline
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale
Time frame: day 5
This is a index to rate the activity of pain based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme. The higher the score, the worse the pain.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale
Time frame: baseline
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale
Time frame: day 5
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale
Time frame: baseline
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale
Time frame: day 5
This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Six-minute Walk Test
Time frame: baseline
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.
Six-minute Walk Test
Time frame: day 5
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.
Short Physical Performance Battery (SPPB)
Time frame: baseline
This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).
Short Physical Performance Battery (SPPB)
Time frame: day 5
This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).
Heat Pain Threshold
Time frame: baseline
Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Heat Pain Threshold
Time frame: day 5
Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Heat Pain Tolerance
Time frame: baseline
Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Heat Pain Tolerance
Time frame: day 5
Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Pressure Pain Threshold
Time frame: baseline
Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.
Pressure Pain Threshold
Time frame: day 5
Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.
Punctate Mechanical Pain Sensitivity
Time frame: baseline
Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.
Punctate Mechanical Pain Sensitivity
Time frame: day 5
Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.
Conditioned Pain Modulation (CPM)
Time frame: baseline
Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.
Conditioned Pain Modulation (CPM)
Time frame: day 5
Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.
12 secondary outcomes
Endorphin Level
Time frame: baseline
Endorphin Level
Time frame: day 5
Cortisol Level
Time frame: baseline
Cortisol Level
Time frame: day 5
C-reactive Protein (CRP) Level
Time frame: baseline
C-reactive Protein (CRP) Level
Time frame: day 5
Tumor Necrosis Factor (TNF) Level
Time frame: baseline
Tumor Necrosis Factor (TNF) Level
Time frame: day 5
Interleukin 6 (IL-6) Level
Time frame: baseline
Interleukin 6 (IL-6) Level
Time frame: day 5
Interleukin 10 (IL-10) Level
Time frame: baseline
Interleukin 10 (IL-10) Level
Time frame: day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28566193Ahn H, Woods AJ, Kunik ME, Bhattacharjee A, Chen Z, Choi E, Fillingim RB. Efficacy of transcranial direct current stimulation over primary motor cortex (anode) and contralateral supraorbital area (cathode) on clinical pain severity and mobility performance in persons with knee osteoarthritis: An experimenter- and participant-blinded, randomized, sham-controlled pilot clinical study. Brain Stimul. 2017 Sep-Oct;10(5):902-909. doi: 10.1016/j.brs.2017.05.007. Epub 2017 May 19.
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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.
Hyochol Ahn, PhD, ARNP principal investigator
The University of Texas Health Science Center, Houston
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 tDCS in people with Knee Osteoarthritis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 7 inclusion and 9 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 11 Jul 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Numeric Rating Scale (NRS) for Pain (time frame: baseline). The study lists 26 primary outcomes in all. 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 NCT02512393, which also lists 1 linked publication.
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 11 Jul 2017.