Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions
NCT05540002 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115
Last updated 2025-03-19
Summary
This study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a Quell for persons with multiple chronic overlapping pain conditions.
Conditions
- Chronic Pain
- Adults 21 and Older
- Multiple Chronic Overlapping Pain Conditions
- Hypersensitivity
Interventions
- DEVICE
-
High Intensity Quell
Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.
- DEVICE
-
Low Intensity Quell
Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.
Sponsors & Collaborators
-
NeuroMetrix, Inc.
collaborator INDUSTRY -
Brigham and Women's Hospital
lead OTHER
Principal Investigators
-
Robert N. Jamison, Ph.D. · Brigham and Women's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-14
- Primary Completion
- 2024-09-19
- Completion
- 2024-09-19
- FDA Device
- Yes
Countries
- United States
Study Locations
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