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

NCT04016259 | Completed Results DMC FDA Device

• 1 other identifier: HSC-SN-19-0452
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (2)

• 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).

  week 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

  week 2

Secondary Outcomes (13)

• Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)

  week 2

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

  week 2

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

  week 2

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

  week 2

• Psychosocial Symptoms as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form

  week 2

Study Arms (2)

Self-CES

EXPERIMENTAL

Device: Cranial Electrical Stimulation (CES)

Sham-CES

PLACEBO COMPARATOR

Device: Sham-CES

Interventions

Cranial Electrical Stimulation (CES) DEVICE

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).

Also known as: Alpha-Stim M

Self-CES

Sham-CES DEVICE

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.

Also known as: Alpha-Stim M

Sham-CES

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Limitations and Caveats

Small sample size; limited demographic (older adults with knee OA) restricts generalizability; slight deviations among intervals between daily stimulation sessions (though, this may be consistent with real-world use); long term efficacy not evaluated

Results Point of Contact

• Title: Hyochol "Brian" Ahn, PhD, RN, MSN, Associate Professor
• Organization: The University of Texas Health Science Center at Houston

Hyochol.Ahn@uth.tmc.edu

713-500-2179

Study Officials

• Hyochol Ahn, PhD, RN, MSN

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 11, 2019
• Study Start: August 1, 2019
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: November 16, 2020
• Results First Posted: November 16, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)