FibromyalgiaNCT03714425
Efficacy of the Quell Wearable Device for Fibromyalgia
A study testing Quell in people with Fibromyalgia, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study is designed for patients with primary fibromyalgia (FM) pain. The overall aim of the study is to determine the effect of the high frequency Quell device to manage FM compared with a low frequency device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Quell
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 1 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have chronic pain related to FM for > 3 months' duration
- average 4 or greater on a pain intensity scale of 0 to 10
- are able to speak and understand English
- have a smartphone (Android or iPhone)
Who cannot join
- diagnosis of cancer or any other malignant disease
- acute osteomyelitis or acute bone disease
- present or 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 (positive on the Mini International Neuropsychiatric Interview; M.I.N.I. v.5.0), that would interfere with study participation
- have an implanted cardiac pacemaker, defibrillator, or other implanted device
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
About this study
This study is designed for patients with primary fibromyalgia (FM) pain. The overall aim of the study is to determine the effect of the high frequency Quell device to manage FM compared with a low frequency device. Investigators hypothesize that those assigned to using the high frequency Quell device will report reduced pain compared with those using the low frequency Quell device; with those using the high frequency device also showing more improvement in sleep, mood, and level of activity. Investigators also hypothesize that frequency of using the Quell (increased tolerability and adherence) will be correlated with greater reduction in pain.
Read the detailed description
The Quell is battery powered with rechargeable batteries and is strapped to participant's upper calf with a velcro band. It has been cleared by the FDA for safety. It is designed to improve fibromyalgia by the principles of transcutaneous electrical stimulation of nerves much like a traditional transcutaneous electrical nerve stimulator (TENS) unit. Investigators expect to enroll approximately 130 subjects in this study. Participants will be equally randomized to one of two experimental groups: High Frequency Quell group (N=65) or Low Frequency Quell group (N=65). This study hopes to find out whether low frequency or high frequency stimulation is most useful among persons with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- Quell
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuellDevice
Quell is a Transcutaneous Electrical Nerve Stimulator Device (TENS). The device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids.
| Study group | Role | What they receive |
|---|---|---|
| High frequency device | Active comparator | Subjects will use high frequency Quell devices. Receives: Device: Quell |
| Low frequency device | Sham comparator | Subjects will use low frequency Quell devices. Receives: Device: Quell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' Global Impression of Change
The questionnaire reflects a patient's belief about the efficacy of treatment. The Patients' Global Impression of Change (PGIC) is a 7-point scale (1-7) depicting a patient's rating of overall improvement. Patients rate their change as 1="very much improved," 2="much improved," 3="minimally improved," 4="no change," 5="minimally worse," 6="much worse," or 7="very much worse." Lower values represent a better outcome.
Measured: 3 months
Secondary outcomes (6)
The Brief Pain Inventory
The Brief Pain Inventory assesses the severity of pain and its impact on functioning. Pain Severity Score is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10 (0-10), where 0 means no pain and 10 is worst possible pain. Pain Interference Score is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10 (0-10), where 0 means does not interfere and 10 means completely interferes. Lower values represent a better outcome.
Measured: Baseline, 3 months
Revised Fibromyalgia Impact Questionnaire
The Revised Fibromyalgia Impact Questionnaire (FIQR) is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. The FIQR has 3 domains: function, overall impact and symptoms. FIQR has 21 individual questions and all questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'. The summed score for function (range 0 to 90) is divided by 3, the summed score for overall impact (range 0 to 20) is not changed, and the summed score for symptoms (range 0 to 100) is divided by 2. The total FIQR is the sum of the three domain scores. The total score of the FIQR ranges from 0 to 100. Lower values represent a better outcome.
Measured: Baseline, 3 months
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The total score is computed by summing responses to all 13 items (scale 0-4). PCS total scores range from 0 - 52. The higher the score, the more catastrophizing thoughts are present. Lower values represent a better outcome.
Measured: Baseline, 3 months
Pain Disability Index
The Pain Disability Index is a simple and rapid instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. The total score is a sum of all 7 categories of life activity listed. A score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which people would normally be involved have been totally disrupted or prevented by the pain. The total index ranges from 0 to 70. The higher the index the greater the person's disability due to pain. Lower values represent a better outcome.
Measured: Baseline, 3 months
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) was developed to assess depression and anxiety in patients. Responses are rated on a scale from 0 to 3, with higher scores indicating higher severity. The ratings of the 14 items are summed to yield a total score (0 to 42), or for each subscale separately (0 to 21). 0 to 7 for normal or no anxiety/depression, 8 to 10 for mild, 11 to 14 for moderate, and 12 to 21 for severe anxiety/depression. Lower values represent a better outcome.
Measured: Baseline, 3 months
Helpfulness Rating
Self-report rating "How helpful was the TENS for your fibromyalgia?" 0=not at all helpful, 10=very helpful.
Measured: Post-treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Feb 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- High frequency device vs. Low frequency device
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert N. Jamison, PhD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714425
- Sponsor's protocol ID
- 2018P002392
- Status last verified
- Jul 2022
- First submitted
- 17 Oct 2018
- Last updated
- 15 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jamison RN, Edwards RR, Curran S, Wan L, Ross EL, Gilligan CJ, Gozani SN. Effects of Wearable Transcutaneous Electrical Nerve Stimulation on Fibromyalgia: A Randomized Controlled Trial. J Pain Res. 2021 Jul 24;14:2265-2282. doi: 10.2147/JPR.S316371. eCollection 2021.
PubMed 34335055
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Quell Wearable Device for Fibromyalgia
- ClinicalTrials.gov ID
- NCT03714425
- Acronym / sponsor ID
- 2018P002392
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Posted 21 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed for patients with primary fibromyalgia (FM) pain. The overall aim of the study is to determine the effect of the high frequency Quell device to manage FM compared with a low frequency device. Investigators hypothesize that those assigned to using the high frequency Quell device will report reduced pain compared with those using the low frequency Quell device; with those using the high frequency device also showing more improvement in sleep, mood, and level of activity. Investigators also hypothesize that frequency of using the Quell (increased tolerability and adherence) will be correlated with greater reduction in pain.
Detailed description
The Quell is battery powered with rechargeable batteries and is strapped to participant's upper calf with a velcro band. It has been cleared by the FDA for safety. It is designed to improve fibromyalgia by the principles of transcutaneous electrical stimulation of nerves much like a traditional transcutaneous electrical nerve stimulator (TENS) unit. Investigators expect to enroll approximately 130 subjects in this study. Participants will be equally randomized to one of two experimental groups: High Frequency Quell group (N=65) or Low Frequency Quell group (N=65). This study hopes to find out whether low frequency or high frequency stimulation is most useful among persons with fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- High frequency device vs. Low frequency device
| Arm | Type | Receives |
|---|---|---|
| High frequency device | Active comparator | Device: QuellSubjects will use high frequency Quell devices. |
| Low frequency device | Sham comparator | Device: QuellSubjects will use low frequency Quell devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- have chronic pain related to FM for > 3 months' duration
- average 4 or greater on a pain intensity scale of 0 to 10
- are able to speak and understand English
- have a smartphone (Android or iPhone)
Key exclusion criteria (8 listed)
- diagnosis of cancer or any other malignant disease
- acute osteomyelitis or acute bone disease
- present or 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 |
|---|---|---|
| QuellQuell is a Transcutaneous Electrical Nerve Stimulator Device (TENS). The device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids. | Device | High frequency device, Low frequency device |
Primary outcome
Patients' Global Impression of Change
Time frame: 3 months
The questionnaire reflects a patient's belief about the efficacy of treatment. The Patients' Global Impression of Change (PGIC) is a 7-point scale (1-7) depicting a patient's rating of overall improvement. Patients rate their change as 1="very much improved," 2="much improved," 3="minimally improved," 4="no change," 5="minimally worse," 6="much worse," or 7="very much worse." Lower values represent a better outcome.
6 secondary outcomes
The Brief Pain Inventory
Time frame: Baseline, 3 months
Revised Fibromyalgia Impact Questionnaire
Time frame: Baseline, 3 months
Pain Catastrophizing Scale
Time frame: Baseline, 3 months
Pain Disability Index
Time frame: Baseline, 3 months
Hospital Anxiety and Depression Scale
Time frame: Baseline, 3 months
Helpfulness Rating
Time frame: Post-treatment at 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34335055Jamison RN, Edwards RR, Curran S, Wan L, Ross EL, Gilligan CJ, Gozani SN. Effects of Wearable Transcutaneous Electrical Nerve Stimulation on Fibromyalgia: A Randomized Controlled Trial. J Pain Res. 2021 Jul 24;14:2265-2282. doi: 10.2147/JPR.S316371. eCollection 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quell in people with Fibromyalgia, 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 4 inclusion and 8 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 15 Aug 2022. 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 21 Jun 2022). 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?
Patients' Global Impression of Change (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03714425, which also lists 1 linked publication.
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 15 Aug 2022.