Clinical trial NCT05540002: Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions
Official title: Efficacy of the Quell Wearable Device for Treatment of Central Sensitization-related Pain Among Persons With Chronic Overlapping Pain Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Adults 21 and Older
Multiple Chronic Overlapping Pain Conditions
Hypersensitivity
Keywords: Multiple Chronic Overlapping Pain Conditions
Adults 21 and older
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: NeuroMetrix, Inc.
First posted: 2022-09-14
Enrollment: 115
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be equally randomized to one of the two treatment groups: the High Intensity Quell group or the Low Intensity Quell group. All groups will receive the same questionnaires and undergo quantitative sensory testing.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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. Participants will attend two quantitative sensory testing visits in order to determine their level of pain sensitivity, one at the beginning of the study and the second at the 3-month Follow-up session. Participants will be asked to test out the Quell device to check for sensation tolerance, and will then be randomized into one of the two treatment groups: the High Intensity Quell group or the Low Intensity Quell group. Participants will be asked to wear the device for at least 3 hours every day and to complete daily assessments, along with a total of three sets of questionnaires: one at the start of the study, the second 6 weeks from the date of consent, and the third 3 months after the date of consent. A member of the research staff will call participants once a week for a brief phone interview throughout the study. Participants will be in this study for 3 months.

Eligibility criteria: Inclusion Criteria:

* Ages 21 and older
* Pain duration \> 3 months
* Diagnosed by physician with multiple chronic pain conditions
* Have chronic pain related to multiple chronic pain diagnoses (headaches, joint pain, back pain, or any of the other COPCs)
* Average 4 or greater on pain intensity scale of 0 to 10
* Pain is not accounted for by any other progressive disease (e.g., cancer, MS)
* Meets sensory hypersensitivity cutoffs based on QST-assessed evidence
* Own a smartphone (iPhone or Android device) and can download the pain app (MasterMyPain) and the Quell Relief mobile app onto their device
* Able to speak and understand English

Exclusion Criteria:

* Diagnosis of cancer or any other malignant disease
* Acute osteomyelitis or acute bone disease
* Present of past DSM-V diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation
* Pregnancy
* Any clinically unstable systemic illness judged to interfere with treatment
* A pain condition requiring urgent surgery
* An active substance use disorder, such as cocaine or IV heroin use that would interfere with study participation
* Have an implanted cardiac pacemaker, defibrillator, or other implanted device.
* Reynaud's syndrome
* Open cuts/sores

Primary outcomes:
measure: The Brief Pain Inventory Interference Scale (BPI)
timeFrame: Between group differences at 3-months
Secondary outcomes:
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Changes from Baseline to 3-month Follow-Up
measure: Pain Disability Index (PDI)
timeFrame: Changes from Baseline to 3-month Follow-Up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Changes from Baseline to 3-month Follow-Up
measure: Pain Detect Neuropathic Pain Questionnaire (painDETECT)
timeFrame: Changes from Baseline to 3-month Follow-Up
measure: Symptom Impact Questionnaire (SIQR)
timeFrame: Changes from Baseline to 3-month Follow-Up
measure: Patient's Global Impression of Change (PGIC)
timeFrame: Changes from Baseline to 3-month Follow-Up
measure: Healthcare Utilization
timeFrame: Changes from Baseline to 3-month Follow-Up
measure: Satisfaction and Qualitative Questions
timeFrame: 3-month Follow-up
measure: Quantitative Sensory Testing (QST)
timeFrame: Changes from Baseline to 3-month Follow-Up
measure: The Brief Pain Inventory Pain Intensity Scale (BPI)
timeFrame: Changes from Baseline to 3-month Follow-Up
measure: MasterMyPain App
timeFrame: Daily ratings over 3-months
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital Pain Management Center
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Robert N. Jamison, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: