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Osteo Arthritis KneeNCT04016259

Self Cranial Electrical Stimulation (CES) for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)

A study testing Cranial Electrical Stimulation (CES) in people with Osteo Arthritis Knee, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the feasibility, safety, and preliminary efficacy of a two-week self Cranial Electrical Stimulation(CES) on 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
Osteo Arthritis Knee
What is being tested?
Cranial Electrical Stimulation (CES)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Aug 2019to 21 Nov 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

  • have self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria
  • 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

  • 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

Other trials in United States

About this study

Official title: Self Cranial Electrical Stimulation for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)

The purpose of this study is to determine the feasibility, safety, and preliminary efficacy of a two-week self Cranial Electrical Stimulation(CES) on pain in older adults with knee osteoarthritis(OA)

Being tested
Cranial Electrical Stimulation (CES), Sham-CES

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cranial Electrical Stimulation (CES)Device

    Also called Alpha-Stim M

    CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).

  • Sham-CESDevice

    Also called Alpha-Stim M

    For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.

Study groups in NCT04016259
Study groupRoleWhat they receive
Self-CESExperimentalNot described
Receives: Device: Cranial Electrical Stimulation (CES)
Sham-CESPlacebo comparatorNot described
Receives: Device: Sham-CES

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Pain as Assessed by a Numeric Rating Scale (NRS) for Pain

    The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable).

    Measured: week 2

  2. 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: week 2

Secondary outcomes (13)
  1. Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)

    In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM).

    To assess HPTH, heat stimuli were delivered to the participant's knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when the sensation ''first becomes painful" to assess the heat pain threshold (HPTH).

    Measured: week 2

  2. Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)

    In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM).

    To assess HPTO, heat stimuli were delivered to the participant's knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when they ''no longer feel able to tolerate the pain" to assess their heat pain tolerance (HPTO).

    Measured: week 2

  3. Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)

    In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM).

    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 knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).

    Measured: week 2

  4. Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)

    In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM).

    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: week 2

  5. Psychosocial Symptoms as Measured 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: week 2

  6. Psychosocial Symptoms as Measured 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: week 2

  7. Psychosocial Symptoms as Measured 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: week 2

  8. Psychosocial Symptoms as Measured by the Pain Catastrophizing Scale (PCS)

    The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. It is measured using the 0 (not at all) to 4 (all the time) scale. Total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.

    Measured: week 2

  9. Number of Participants With a Significant Change in Pain-related Cortical Response on Average as Assessed by a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System

    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, week 2

  10. Participant Satisfaction With Treatment Using the Client Satisfaction Questionnaire (CSQ-8)

    The CSQ-8 comprises eight items that are summed to yield an overall score of 8-32, with higher scores indicating greater satisfaction.

    Measured: week 2

  11. Feasibility as Measured by the Number of Participants That Completed the Full CES Protocol

    Measured: week 2

  12. Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience

    CES experience will be measured on a 10-item scale, with each item rated 0-10 and 0 being strongly disagree and 10 being strongly agree. Total score ranges from 0 to 100, with higher scores indicating a better CES experience.

    Question 1. It was easy to prepare the device and accessories Question 2. The device was unnecessarily complex Question 3. The device was easy to use Question 4. I felt the video conferences with a technical person were helpful Question 5. I would imagine that most people would learn to use this device quickly Question 6. The device was cumbersome to use Question 7. I felt confident using the device Question 8. I needed to learn a lot of things before I could get going with this device Question 9. The effectiveness of the treatment increased over the course of treatment Question 10. I felt that transcranial electrical stimulation treatment benefited me

    Measured: week 2

  13. Tolerability as Indicated by Number of Participants With Possible Side Effects of Treatment

    Measurement of presence and severity of possible side effects of treatment on a 0 (not at all) to 10 (highest degree) scale.If any side effects are reported, the degree of relatedness to the intervention will be assessed on a 5-point scale.

    Measured: week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2019
  2. Study start1 Aug 2019
  3. Primary completion21 Nov 2019
  4. Study completion21 Nov 2019

Resources

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
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04016259
Sponsor's protocol ID
HSC-SN-19-0452
Status last verified
Oct 2020
First submitted
9 Jul 2019
Last updated
16 Nov 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cranial Electrical Stimulation (CES) in people with Osteo Arthritis Knee, 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 6 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 16 Nov 2020. 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 16 Nov 2020). 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?

Clinical Pain as Assessed by a Numeric Rating Scale (NRS) for Pain (time frame: week 2). The study lists 2 primary outcomes in all. 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 16 Nov 2020.

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