Knee OsteoarthritisNCT03747640
Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis
A study testing Self Transcranial Direct Current Stimulation (tDCS) and mindfulness-based meditation 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 study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain in older adults with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Self Transcranial Direct Current Stimulation (tDCS) and mindfulness-based meditation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2018to 8 Mar 2019
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria. According to American College of Rheumatology criteria, participants should meet at least 3 of 6 criteria, including age > 50 years, stiffness < 30 minutes, crepitus, bony tenderness, bony enlargement, and no palpable warmth.
- have had knee OA pain in the past 3 months with an average of at least 30 on a 100 Numeric Rating Scale (NRS) for pain
- can speak and read English
- have a device with internet access that can be used for secure video conferencing for real-time remote supervision
- have no plan to change medication regimens for pain throughout the trial
- are able to travel to the coordinating center
- are willing and able to provide written informed consent prior to enrollment
Who cannot join
- Participants will be excluded if they have concurrent medical conditions that hinder the completion of the protocol, including any of the following
- history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
- serious medical illness, such as uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg), heart failure, or history of acute myocardial infarction
- alcohol/substance abuse
- cognitive impairment
- pregnancy or lactation
- hospitalization within the preceding year for psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis (Self tDCS and Meditation for Knee Pain)
The purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain in older adults with knee osteoarthritis (OA).
- Conditions
- Knee Osteoarthritis
- Being tested
- Self Transcranial Direct Current Stimulation (tDCS), mindfulness-based meditation, Sham Self Transcranial Direct Current Stimulation (tDCS), sham meditation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Transcranial Direct Current Stimulation (tDCS)Device
tDCS with a constant current intensity of 2 milliamps (mA) will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
mindfulness-based meditationBehavioural
The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
Sham Self Transcranial Direct Current Stimulation (tDCS)Device
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.
sham meditationBehavioural
For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
| Study group | Role | What they receive |
|---|---|---|
| tDCS with mindfulness-based meditation | Experimental | Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation Receives: Device: Self Transcranial Direct Current Stimulation (tDCS); Behavioral: mindfulness-based meditation |
| sham tDCS with sham meditation | Sham comparator | Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation Receives: Device: Sham Self Transcranial Direct Current Stimulation (tDCS); Behavioral: sham meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS)
The NRS assess average pain over the past 24 hours from 0 (no pain) to 100 (most intense pain imaginable).
Measured: baseline, 2 weeks
Secondary outcomes (17)
Change in Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC ranges from 0 to 96, with higher scores indicating worse osteoarthritis (OA) pain-related symptoms.
Measured: baseline, 2 weeks
Psychosocial Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-short Form
The 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Measured: baseline
Psychosocial Symptoms as Assessed by the PROMIS Anxiety-short Form
The 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Measured: 2 weeks
Psychosocial Symptoms as Assessed by PROMIS Depression-short Form
The 8-item PROMIS Depression Short Form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Measured: baseline
Psychosocial Symptoms as Assessed by PROMIS Depression-short Form
The 8-item PROMIS Depression Short Form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Measured: 2 weeks
Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form
The 8-item PROMIS Sleep Disturbance Short Form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Measured: baseline
Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form
The 8-item PROMIS Sleep Disturbance Short Form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Measured: 2 weeks
Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. Each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).The PCS total score is computed by summing responses to all 13 items, with total scores ranging from 0 - 52. Higher scores indicate a worse outcome.
Measured: baseline
Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. Each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).The PCS total score is computed by summing responses to all 13 items, with total scores ranging from 0 - 52. Higher scores indicate a worse outcome.
Measured: 2 weeks
Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI)
The Freiburg Mindfulness Inventory (FMI) is a 14-item instrument. Respondents indicate their experiences relating to the items on a 4-point Likert scale (rarely, occasionally, fairly often and almost always), and the total score is calculated by adding all the scores on the 14 items of the FMI. Total scores range from 14-56, with higher scores indicating higher levels of mindfulness.
Measured: baseline
Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI)
The Freiburg Mindfulness Inventory (FMI) is a 14-item instrument. Respondents indicate their experiences relating to the items on a 4-point Likert scale (rarely, occasionally, fairly often and almost always), and the total score is calculated by adding all the scores on the 14 items of the FMI. Total scores range from 14-56, with higher scores indicating higher levels of mindfulness.
Measured: 2 weeks
Change in Experimental Pain Sensitivity as Assessed by Conditioned Pain Modulation
Conditioned Pain Modulation (CPM) was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 12 degrees C for one minute. [To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).]
Measured: baseline, 2 weeks
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS)
Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation.
Measured: baseline
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy
Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation.
Measured: 2 weeks
Change in Experimental Pain Sensitivity as Assessed by Cold Pain Intensity
Participants immersed their hand in a cold water bath, and at thirty seconds after hand immersion, they rated the cold pain intensity on a scale of 0-100. A higher score indicating higher pain intensity.
Measured: baseline, 2 weeks
Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Lateral Knee
To assess pressure pain threshold (PPT), a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).
Measured: baseline, 2 weeks
Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Medial Knee
To assess pressure pain threshold (PPT), a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).
Measured: baseline, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start28 Nov 2018
- Primary completion8 Mar 2019
- Study completion8 Mar 2019
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.
- Other trials for Knee OsteoarthritisStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyochol Ahn, The University of Texas Health Science Center, Houston
- Investigators
- Hyochol Ahn, PhD, RN, MSN, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747640
- Sponsor's protocol ID
- HSC-SN-18-0885
- Status last verified
- Mar 2022
- First submitted
- 16 Nov 2018
- Last updated
- 25 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis (Self tDCS and Meditation for Knee Pain)
- ClinicalTrials.gov ID
- NCT03747640
- Acronym / sponsor ID
- HSC-SN-18-0885
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Posted 25 Mar 2022
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 determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain in older adults with knee osteoarthritis (OA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS with mindfulness-based meditation | Experimental | Device: Self Transcranial Direct Current Stimulation (tDCS), Behavioral: mindfulness-based meditationSelf Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation |
| sham tDCS with sham meditation | Sham comparator | Device: Sham Self Transcranial Direct Current Stimulation (tDCS), Behavioral: sham meditationSham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria. According to American College of Rheumatology criteria, participants should meet at least 3 of 6 criteria, including age > 50 years, stiffness < 30 minutes, crepitus, bony tenderness, bony enlargement, and no palpable warmth.
- have had knee OA pain in the past 3 months with an average of at least 30 on a 100 Numeric Rating Scale (NRS) for pain
- can speak and read English
- have a device with internet access that can be used for secure video conferencing for real-time remote supervision
- have no plan to change medication regimens for pain throughout the trial
Key exclusion criteria (7 listed)
- Participants will be excluded if they have concurrent medical conditions that hinder the completion of the protocol, including any of the following
- history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
- serious medical illness, such as uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg), heart failure, or history of acute myocardial infarction
- alcohol/substance abuse
- cognitive impairment
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 |
|---|---|---|
| Self Transcranial Direct Current Stimulation (tDCS)tDCS with a constant current intensity of 2 milliamps (mA) will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes. | Device | tDCS with mindfulness-based meditation |
| mindfulness-based meditationThe meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player. | Behavioural | tDCS with mindfulness-based meditation |
| Sham Self Transcranial Direct Current Stimulation (tDCS)For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds. | Device | sham tDCS with sham meditation |
| sham meditationFor sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention. | Behavioural | sham tDCS with sham meditation |
Primary outcome
Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS)
Time frame: baseline, 2 weeks
The NRS assess average pain over the past 24 hours from 0 (no pain) to 100 (most intense pain imaginable).
17 secondary outcomes
Change in Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: baseline, 2 weeks
Psychosocial Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-short Form
Time frame: baseline
Psychosocial Symptoms as Assessed by the PROMIS Anxiety-short Form
Time frame: 2 weeks
Psychosocial Symptoms as Assessed by PROMIS Depression-short Form
Time frame: baseline
Psychosocial Symptoms as Assessed by PROMIS Depression-short Form
Time frame: 2 weeks
Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form
Time frame: baseline
Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form
Time frame: 2 weeks
Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS)
Time frame: baseline
Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS)
Time frame: 2 weeks
Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI)
Time frame: baseline
Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI)
Time frame: 2 weeks
Change in Experimental Pain Sensitivity as Assessed by Conditioned Pain Modulation
Time frame: baseline, 2 weeks
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS)
Time frame: baseline
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy
Time frame: 2 weeks
Change in Experimental Pain Sensitivity as Assessed by Cold Pain Intensity
Time frame: baseline, 2 weeks
Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Lateral Knee
Time frame: baseline, 2 weeks
Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Medial Knee
Time frame: baseline, 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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, RN, MSN 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 Self Transcranial Direct Current Stimulation (tDCS) and mindfulness-based meditation 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 7 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 25 Mar 2022. 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 25 Mar 2022). 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?
Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS) (time frame: baseline, 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2022.