Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04016259
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hyochol Ahn, The University of Texas Health Science Center, Houston

Brief 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)

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Device: Cranial Electrical Stimulation (CES) Device: Sham-CES Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self Cranial Electrical Stimulation for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Self-CES Device: Cranial Electrical Stimulation (CES)
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).
Other Name: Alpha-Stim M

Placebo Comparator: Sham-CES Device: Sham-CES
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.
Other Name: Alpha-Stim M




Primary Outcome Measures :
  1. Change in clinical pain as assessed by the numeric rating scale (NRS) for pain [ Time Frame: Baseline, week 2 ]
    The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable).

  2. Change in clinical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Baseline, week 2 ]
    The WOMAC ranges from 0 to 96, with higher scores indicating worse OA pain-related symptoms


Secondary Outcome Measures :
  1. Change in Psychosocial symptoms as measured by the Patient-Reported Outcomes Measurement Information System(PROMIS) anxiety-short form [ Time Frame: Baseline, week 2 ]
    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.

  2. Change in Psychosocial symptoms as measured by the PROMIS depression-short form [ Time Frame: Baseline, week 2 ]
    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.

  3. Change in Psychosocial symptoms as measured by the PROMIS sleep disturbance-short form scale [ Time Frame: Baseline, week 2 ]
    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.

  4. Change in Psychosocial symptoms as measured by the Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline, week 2 ]
    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.

  5. Change in Experimental Pain Sensitivity as measured using a multimodal Quantitative Sensory Testing (QST) battery [ Time Frame: Baseline, week 2 ]
    In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain sensitivity, pressure pain sensitivity, punctate mechanical pain, and Conditioned Pain Modulation (CPM).

  6. Change in pain related cortical response using a continuous wave, multichannel Functional near-infrared spectroscopy (fNIRS) imaging system [ Time Frame: baseline, week 2 ]
    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.

  7. Participant satisfaction with treatment using the Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: week 2 ]
    The CSQ-8 comprises eight items that are summed to yield an overall score of 8-32, with higher scores indicating greater satisfaction.

  8. Feasibility as measured by the number of participants that completed the full CES protocol [ Time Frame: week 2 ]
  9. Feasibility as indicated by Participant's Cranial Electrical Stimulation (CES) experience [ Time Frame: week 2 ]
    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.

  10. Tolerability as indicated by number of participants with possible side effects of treatment [ Time Frame: week 2 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016259


Contacts
Layout table for location contacts
Contact: Hyochol Ahn, PhD, RN, MSN 7135002179 Hyochol.Ahn@uth.tmc.edu

Locations
Layout table for location information
United States, Texas
The University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Hyochol Ahn    713-500-2179    Hyochol.Ahn@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: Hyochol Ahn, PhD, RN, MSN The University of Texas Health Science Center, Houston

Layout table for additonal information
Responsible Party: Hyochol Ahn, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04016259     History of Changes
Other Study ID Numbers: HSC-SN-19-0452
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases