COMPLETED

Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life

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

The goal of this counterbalanced cross-over study is to determine whether a recovery lumbar wrap effectively reduces lower back pain and improves outcomes related to physical function and quality of life in adults with LBP in adults 20-65 years old. This study will also explore whether improvements in other health metrics that are typically related to, or seen in, lower back pain research (i.e. stiffness, mobility, physical activity, validated clinical scoring methods, etc.) are improved with the use of the product. The main question this study aims to answer is: • Does the lumbar wrap effectively reduce low back pain symptoms and improve outcomes related to physical function and quality of life in adults with lower back pain. Participants experiencing lower back pain will be asked to use the lower back wrap for at least 20-minutes per day for a 2-week period, counterbalanced with a 2-week period of no device use. Participants will fill out small daily surveys about their symptoms and complete a pre-, middle-, and post- survey and functional screening to determine efficacy of the device.

Official Title

Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life

Quick Facts

Study Start:2024-12-02
Study Completion:2025-05-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06749912

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:20 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged 20 - 65
  2. * Males and Females (50-50 split or close)
  3. * Range of ethnicities
  4. * Range of BMIs
  1. * Those with diagnosed cancer, infection, trauma, or LBP requiring surgical intervention
  2. * Those currently undergoing rehabilitation treatment for LBP
  3. * Those with other diagnosed conditions that may preclude them from safely participating
  4. * Pregnant women
  5. * Waist less than 26" or greater than 66" due to device limitations

Contacts and Locations

Principal Investigator

Kyle J Kelleran, PhD
PRINCIPAL_INVESTIGATOR
University at Buffalo

Study Locations (Sites)

University at Buffalo
Buffalo, New York, 14203
United States

Collaborators and Investigators

Sponsor: State University of New York at Buffalo

  • Kyle J Kelleran, PhD, PRINCIPAL_INVESTIGATOR, University at Buffalo

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 Date2024-12-02
Study Completion Date2025-05-23

Study Record Updates

Study Start Date2024-12-02
Study Completion Date2025-05-23

Terms related to this study

Keywords Provided by Researchers

  • Low back pain
  • acute low back pain
  • symptom reduction
  • pain sensation

Additional Relevant MeSH Terms

  • Lower Back Pain
  • Lower Back Pain Chronic
  • Acute Low Back Pain