Efficacy of the Quell Wearable Device for Chronic Low Back Pain

NCT02944513 | Completed Results

• 1 other identifier: 2016P002172
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a 1-year trial designed to gather information about the use of the Quell for persons with chronic musculoskeletal low back pain.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (5)

• Pain Intensity (Average)

  Rate average pain intensity using visual analog scale on a scale of 0-10, where 0 is no pain and 10 is worst possible pain. Higher scores mean a worse outcome.

  3 months

• Average Pain Interference

  This measures the average pain interference with general activity, mood, walking ability, normal work, relations with others, sleep and enjoyment of life using visual analogue scale. On a scale of 0-10, 0 is no interference and 10 is extreme interference. Higher scores mean worse outcome.

  3 months

• Pain Disability Index

  The Pain Disability Index (PDI) a simple and rapid instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. For each of the 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 you would normally be involved have been totally disrupted or prevented by your pain. The minimal index is 0 and maximal index is 70. The higher the index the greater the person's disability due to pain meaning a worse outcome.

  3 months

• Pain Catastrophizing Scale

  Pain Catastrophizing Scale (PCS) has thirteen statements describing different thoughts and feelings that may be associated with pain. Using a 5-point scale from 0 (Not at all) to 4 (all the time), people indicate the degree to which they have these thoughts and feelings when they are experiencing pain. The sum has a minimum of 0 and a maximum of 52. Higher scores mean high levels of pain catastrophizing and worse outcome.

  3 months

• Hospital Anxiety and Depression Scale Total Score

  Hospital Anxiety and Depression Scale (HADS) is commonly used to determine the levels of anxiety and depression that a person is experiencing. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. This outcome is a total score, which was calculated by adding the anxiety score and the depression score. Total score ranges from 0-42, with higher scores indicating a worse outcome.

  3 months

Secondary Outcomes (1)

• Post-study Helpfulness Questionnaire

  3 months

Study Arms (2)

Experimental

EXPERIMENTAL

Subjects will receive the Quell device

Device: Quell

Control

NO INTERVENTION

Subjects will not receive the Quell device

Interventions

Quell DEVICE

Experimental

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants will be adults age 21 or older and diagnosed with axial musculoskeletal back pain without radiculopathy.
• Patients will be invited to participate if they own a smart phone (iPhone or Android device) and are able to download the pain app and the Quell Relief program app onto their device.
• Patients will also be included if they:
• have chronic pain for \> 3 months' duration
• average 4 or greater on a pain intensity scale of 0 to 10
• are able to speak and understand English.

You may not qualify if:

• Patients will be excluded from participation if they meet any of the following criteria:
• diagnosis of cancer or any other malignant disease
• acute osteomyelitis or acute bone disease
• present or past Diagnostic and Statistical Manual-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
• any prescription opioid use for pain
• have an implanted cardiac pacemaker, defibrillator, or other implanted device. All subjects will be asked to not change their treatment during the study period.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (1)

• Jamison RN, Wan L, Edwards RR, Mei A, Ross EL. Outcome of a High-Frequency Transcutaneous Electrical Nerve Stimulator (hfTENS) Device for Low Back Pain: A Randomized Controlled Trial. Pain Pract. 2019 Jun;19(5):466-475. doi: 10.1111/papr.12764. Epub 2019 Feb 4.

  PMID: 30636101 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1. followed for only three months 2. no active comparator treatment in the control group 3. hard to know how other treatments or environmental factors might have affected the outcome of this study

Results Point of Contact

• Title: Dr. Robert Jamison
• Organization: Brigham and Women's Hospital

rjamison@bwh.harvard.edu

617-732-9046

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 26, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 25, 2022
• Results First Posted: February 26, 2019

Record last verified: 2022-04