The Spine Phenome Project

NCT05776771 | Recruiting

• 2 other identifiers: 2020H02504UH3AR076729-02
• Study Type: observational
• Target: 10,500
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Low Back Pain; Neck Pain

Outcome Measures

Primary Outcomes (2)

• Motion Index

  Composite functional score ranging from 0 - 100, with higher scores indicating healthier function. This is a composite metric derived from a standardized sensor-enabled spinal motion assessment. Motion features extracted from the motion assessment are benchmarked against a normative population.

  2030

• Patient's Global Impression of Change (PGIC)

  PGIC is a 7 point scale indicating a patient's preception of overall improvement after treatment. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."

  2030

Secondary Outcomes (2)

• PROMIS-29

  2030

• Pain Catastrophizing scale (PCS-6)

  2030

Study Arms (3)

Low Back Pain

Subjects with Low Back Pain

Neck Pain

Subjects with Neck Pain

Control/Insincere

Subjects with healthy spines, who have no neck or low back pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There are 3 different study populations: Controls/Insincere, Low Back Pain, and Neck Pain

You may qualify if:

• Age 18 and older
• Able to stand for 20 minutes
• Able to speak, read, and understand English

You may not qualify if:

• Known pregnancy
• Currently seeing or planning to see a medical provider for low back or neck pain
• History of chronic low back or neck pain lasting longer than 3 months
• Blind or severe uncorrected vision problems that prevent participant from reading a tablet or laptop screen
• Deaf or hearing problems that prevent the participant from hearing verbal instructions
• Actively being treated by a medical provider for concussion
• Known severe spinal deformity requiring medical treatment (e.g. scoliosis)
• Has been diagnosed by a medical provider with severe vertigo, fainting, narcolepsy, or balance disorders with high risk for falling
• Any known fractures within the last 3 months that will interfere with the motion assessment
• History of spine fracture
• Current condition requiring immobilization or bracing of the spine
• History of spine surgery (e.g. fusion, micro-discectomy, or artificial disc replacement)
• History of brain or spine cancer
• Currently or within the last 90 days, been treated for cancer with chemotherapy or radiation therapy
• Known severe osteoporosis requiring medical treatment and physician-recommended physical restrictions

Sponsors & Collaborators

• Ohio State University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (1)

• Mageswaran P, Dufour J, Aurand A, Knapik G, Hani H, Blakaj DM, Khan S, Hussain N, Tiwari M, Vallabh J, Weaver T, Marras WS. Wearable motion-based platform for functional spine health assessment. Reg Anesth Pain Med. 2024 Jul 8;49(7):518-527. doi: 10.1136/rapm-2023-104840.

  PMID: 37813527 DERIVED

MeSH Terms

Conditions

Low Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lindsay Hanes, BS, CCRC

CONTACT

614-257-2294; lindsay.hanes@osumc.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of SRI

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 20, 2023
• Study Start: December 18, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)