RECRUITING

Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Pain symptoms can have a variety of ways to be treated, from medications to physical therapy, with several options being available to patients. However, no one treatment may work for all people who experience pain, especially cLBP. The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP). The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. In isolation, these treatments are only somewhat effective in reducing symptoms. This pilot study will involve participants who experience cLBP as we investigate a novel at-home, multi-modal device design. The main objective of the pilot usability study is to examine compliance to the intended use of the multi-modal device and approach, as well as protocol feasibility, and satisfaction with the settings and design.

Official Title

Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain

Quick Facts

Study Start:2024-07-01
Study Completion:2025-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06619418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must be 18 years of age or older
  2. * Must be within commuting distance to the University of Minnesota
  3. * Able to provide consent and follow study instructions
  4. * Must be able to understand English
  5. * Must have chronic LBP, which is defined as lower back pain for more than 3 months
  6. * A score of 4 or higher on the PEG
  7. * Must be willing to commit to full duration of the study
  8. * Not currently taking any benzodiazepines or sedative hypnotics
  1. * Back Pain associated with:
  2. * Spondylolisthesis or spinal stenosis
  3. * Sciatica or radiculopathy
  4. * Rhematologic or inflammatory disease
  5. * Trauma, fracture, dislocation, or previous back surgery
  6. * A score of 10 on the PEG
  7. * Pregnant
  8. * Have an electrically implanted device, such as a pacemaker.
  9. * Heart Disease
  10. * Epilepsy
  11. * Cancer
  12. * Psychiatric conditions including psychosis, suicidal ideation, or substance abuse disorder
  13. * A pure tone average of more than 40 dB HL at 500 dB, 1000 dB, or 2000 dB HL.
  14. * Individuals currently using other lower back pain treatments during the study in which they are unable to maintain a steady state while participating in our study for one month before beginning the multi-modal regimen.

Contacts and Locations

Study Contact

Grace Conchas
CONTACT
buchh123@umn.edu

Principal Investigator

Molly Sturges
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Molly Sturges, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2025-08-01

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2025-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Lower Back Pain