RECRUITING

The Spine Phenome Project

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 observational trial is to compare the health history and motion capabilities of participants with low back pain disorders to participants with healthy spines. The main question\[s\] it aims to answer are to: 1. Primary outcomes of this research effort include composite measures that differentiate between control and patient populations, predict injury or reinjury risk, identify low back and neck pain patient phenotypes, and evaluate treatment effectiveness. 2. Secondary outcomes of this research effort include an assessment of wearable motion sensor accuracy, characterization of motion assessment utility, biopsychosocial profiling of control and low back and neck pain patient populations, and differentiation of sincere and insincere motion assessment efforts. Participants will complete questionnaires and wear a motion monitor that will assess your back and/or neck. This session will be approximately 40-70 minutes. The research team will follow up with participants at 3 month, 6 months, 1 year, 2 years, 5 years to complete a short series of questionnaires and a motion assessment test.

Official Title

The Spine Phenome Project: Enabling Technology for Personalized Medicine

Quick Facts

Study Start:2020-12-18
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05776771

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:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Known pregnancy
  2. * Currently seeing or planning to see a medical provider for low back or neck pain
  3. * History of chronic low back or neck pain lasting longer than 3 months
  4. * Blind or severe uncorrected vision problems that prevent participant from reading a tablet or laptop screen
  5. * Deaf or hearing problems that prevent the participant from hearing verbal instructions
  6. * Actively being treated by a medical provider for concussion
  7. * Known severe spinal deformity requiring medical treatment (e.g. scoliosis)
  8. * Has been diagnosed by a medical provider with severe vertigo, fainting, narcolepsy, or balance disorders with high risk for falling
  9. * Any known fractures within the last 3 months that will interfere with the motion assessment
  10. * History of spine fracture
  11. * Current condition requiring immobilization or bracing of the spine
  12. * History of spine surgery (e.g. fusion, micro-discectomy, or artificial disc replacement)
  13. * History of brain or spine cancer
  14. * Currently or within the last 90 days, been treated for cancer with chemotherapy or radiation therapy
  15. * Known severe osteoporosis requiring medical treatment and physician-recommended physical restrictions
  16. * Current open wounds or medical device entry points where the harnesses will be placed on the neck, back, or hips
  17. * Current osteomyelitis or spine infection
  18. * Any other reason that a treating physician, researcher, or participant determines it is unsafe for a patient to perform test
  19. * Age 18 and older
  20. * Currently seeking medical consult with primary complaint of low back pain
  21. * Able to speak, read, and understand English
  22. * Able to stand for 10 minutes

Contacts and Locations

Study Contact

Lindsay Hanes, BS, CCRC
CONTACT
614-257-2294
lindsay.hanes@osumc.edu

Study Locations (Sites)

The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

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 Date2020-12-18
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2020-12-18
Study Completion Date2030-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Low Back Pain
  • Neck Pain