Chronic PainNCT05540002
Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions
A study testing High Intensity Quell and Low Intensity Quell in people with Chronic Pain and Adults 21 and Older, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Chronic Pain, Adults 21 and Older, Multiple Chronic Overlapping Pain Conditions
- What is being tested?
- High Intensity Quell and Low Intensity Quell
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2022to 19 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital Pain Management Center
Chestnut Hill, Massachusetts, 02467
About this study
Official title: Efficacy of the Quell Wearable Device for Treatment of Central Sensitization-related Pain Among Persons With Chronic Overlapping Pain Conditions
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.
Read the 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.
- Conditions
- Chronic Pain, Adults 21 and Older, Multiple Chronic Overlapping Pain Conditions, Hypersensitivity
- Being tested
- High Intensity Quell, Low Intensity Quell
- Keywords
- Multiple Chronic Overlapping Pain Conditions, Adults 21 and older
- Medical subject headings
- Chronic Pain, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity QuellDevice
Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.
Low Intensity QuellDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Stimulation | Active comparator | Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. Receives: Device: High Intensity Quell |
| Low Intensity Stimulation | Sham comparator | Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. Receives: Device: Low Intensity Quell |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Brief Pain Inventory Interference Scale (BPI)
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.
Measured: Between group differences at 3-months
Secondary outcomes (11)
Pain Catastrophizing Scale (PCS)
Measures thoughts and feelings when patient is experiencing pain on a 13-item scale ranging from 0-52 with higher scores meaning a worse outcome and higher catastrophizing
Measured: Changes from Baseline to 3-month Follow-Up
Pain Disability Index (PDI)
Rating scales designed to measure levels of pain disability, or the degree to which pain is preventing a patient from doing what they normally would be doing, or doing it as well as they normally would on a 7-item scale of 0-10 ranging from 0-70 with higher scores meaning a worse outcome
Measured: Changes from Baseline to 3-month Follow-Up
Hospital Anxiety and Depression Scale (HADS)
Measures mood on a 14-item scale ranging from 0 to 42 with higher scores meaning a worse outcome
Measured: Changes from Baseline to 3-month Follow-Up
Pain Detect Neuropathic Pain Questionnaire (painDETECT)
Measures the presence of neuropathic pain on a scale ranging from 1 to 38 on ratings of 'never to very strongly' with higher scores meaning a worse outcome
Measured: Changes from Baseline to 3-month Follow-Up
Symptom Impact Questionnaire (SIQR)
Measures 20 pain symptoms and function on a scale of 0-10 with scores ranging from 0 to 200 with higher scores meaning a worse outcome
Measured: Changes from Baseline to 3-month Follow-Up
Patient's Global Impression of Change (PGIC)
Measures the subject's overall belief about the efficacy of treatment on a 7-point categorical verbal rating scale. The scale ranges from (1) "no change or condition has gotten worse" to (7) "a great deal better and a considerable improvement that has made all the difference.
Measured: Changes from Baseline to 3-month Follow-Up
Healthcare Utilization
Monthly clinic and ED visits
Measured: Changes from Baseline to 3-month Follow-Up
Satisfaction and Qualitative Questions
A satisfaction questionnaire was developed for this study specifically related to use of the pain management device (Quell) and use of the study app. Ten items related to use of the device and five items were related to use of the smartphone study app all rated on a scale of 0 (worse) to 10 (better). Below are group differences on "How willing would you be to using the Quell in the future?" rated from 0=Not at all willing to 10=Very willing. This questionnaire was only administered at the end of the trial.
Measured: 3-month Follow-up
Quantitative Sensory Testing (QST)
Set of psychophysical methods used to quantify somatosensory function. Combined hypersensitivity measure that measures responses to repeated touch, mechanical/pressure pain assessment, and cold pain assessment. Overall sensitivity based on z scores categorized into high and low sensitivity. Higher scores represent less sensitivity. The mean score is 0.
Measured: Changes from Baseline to 3-month Follow-Up
The Brief Pain Inventory Pain Intensity Scale (BPI)
Average pain on a scale of 0-10 with higher scores meaning a worse outcome
Measured: Changes from Baseline to 3-month Follow-Up
MasterMyPain App
Daily ratings of pain related factors on smartphone pain app on a scale of 0-10 with higher scores meaning a worse outcome. Multiple daily assessments were averaged for mean and standard deviation scores.
Measured: Daily ratings over 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start14 Oct 2022
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroMetrix, Inc.
- Responsible party
- Principal investigator, Robert N. Jamison, PhD, Brigham and Women's Hospital
- Investigators
- Robert N. Jamison, Ph.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540002
- Sponsor's protocol ID
- 2022P002083
- Status last verified
- Feb 2025
- First submitted
- 12 Sep 2022
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Quell Wearable Device for Treatment of Central Sensitization-related Pain Among Persons With Chronic Overlapping Pain Conditions
- ClinicalTrials.gov ID
- NCT05540002
- Acronym / sponsor ID
- 2022P002083
- Conditions
- Chronic Pain, Adults 21 and Older, Multiple Chronic Overlapping Pain Conditions, Hypersensitivity
- Keywords
- Multiple Chronic Overlapping Pain Conditions, Adults 21 and older
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- NeuroMetrix, Inc.
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| High Intensity Stimulation | Active comparator | Device: High Intensity QuellPatients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks. |
| Low Intensity Stimulation | Sham comparator | Device: Low Intensity QuellPatients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity QuellParticipants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day. | Device | High Intensity Stimulation |
| Low Intensity QuellParticipants 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. | Device | Low Intensity Stimulation |
Primary outcome
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.
11 secondary outcomes
Pain Catastrophizing Scale (PCS)
Time frame: Changes from Baseline to 3-month Follow-Up
Pain Disability Index (PDI)
Time frame: Changes from Baseline to 3-month Follow-Up
Hospital Anxiety and Depression Scale (HADS)
Time frame: Changes from Baseline to 3-month Follow-Up
Pain Detect Neuropathic Pain Questionnaire (painDETECT)
Time frame: Changes from Baseline to 3-month Follow-Up
Symptom Impact Questionnaire (SIQR)
Time frame: Changes from Baseline to 3-month Follow-Up
Patient's Global Impression of Change (PGIC)
Time frame: Changes from Baseline to 3-month Follow-Up
Healthcare Utilization
Time frame: Changes from Baseline to 3-month Follow-Up
Satisfaction and Qualitative Questions
Time frame: 3-month Follow-up
Quantitative Sensory Testing (QST)
Time frame: Changes from Baseline to 3-month Follow-Up
The Brief Pain Inventory Pain Intensity Scale (BPI)
Time frame: Changes from Baseline to 3-month Follow-Up
MasterMyPain App
Time frame: Daily ratings over 3-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Link to rally website to Quell COPCsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert N. Jamison, Ph.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Quell and Low Intensity Quell in people with Chronic Pain and Adults 21 and Older, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Brief Pain Inventory Interference Scale (BPI) (time frame: Between group differences at 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.