Efficacy of the Quell Wearable Device for Treatment of Central Sensitization-related Pain Among Persons With Chronic Overlapping Pain Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- The Brief Pain Inventory Interference Scale (BPI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Neither the principal investigator, the co-investigators, the research assistant, or the subjects will know if they are given the high intensity Quell device or the low intensity Quell device.
Eligibility Criteria
- Ages
- 21 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
High Intensity Stimulation
Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.
Intervention: High Intensity Quell (Device)
Low Intensity Stimulation
Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.
Intervention: Low Intensity Quell (Device)
Outcomes
Primary Outcomes
The Brief Pain Inventory Interference Scale (BPI)
Time Frame: Between group differences at 3-months
This is a validated measure of combined activity interference on a numerical scale of 0-10, with higher scores representing greater activity interference. We collected ratings on how much pain interfered over the past 24 hours with 1) General activity, 2) Mood, 3) Walking ability, 4) Normal work, 5) Relations with other people, 6) Sleep, and 7) Enjoyment of life on a scale of 0=does not interfere to 10=completely interferes. The table represents combined mean scores between groups. These ratings were collected at 3 months after start of the study.
Secondary Outcomes
- MasterMyPain App(Daily ratings over 3-months)
- Pain Catastrophizing Scale (PCS)(Changes from Baseline to 3-month Follow-Up)
- Pain Disability Index (PDI)(Changes from Baseline to 3-month Follow-Up)
- Hospital Anxiety and Depression Scale (HADS)(Changes from Baseline to 3-month Follow-Up)
- Pain Detect Neuropathic Pain Questionnaire (painDETECT)(Changes from Baseline to 3-month Follow-Up)
- Symptom Impact Questionnaire (SIQR)(Changes from Baseline to 3-month Follow-Up)
- Patient's Global Impression of Change (PGIC)(Changes from Baseline to 3-month Follow-Up)
- Healthcare Utilization(Changes from Baseline to 3-month Follow-Up)
- Satisfaction and Qualitative Questions(3-month Follow-up)
- Quantitative Sensory Testing (QST)(Changes from Baseline to 3-month Follow-Up)
- The Brief Pain Inventory Pain Intensity Scale (BPI)(Changes from Baseline to 3-month Follow-Up)
Investigators
Robert N. Jamison, PhD
Principal Investigator
Brigham and Women's Hospital