Wearable Spine Health System for Military Readiness

Low Back Pain Clinical Trial

Official title:

Wearable Spine Health System for Military Readiness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944354
• Other study ID #: 2022X0054
• Status: Recruiting
• Start date: September 23, 2022
• Est. completion date: December 31, 2032

Study information

• Verified date: January 2024
• Source: Ohio State University
• Contact: Lindsay Hanes, BS, CCRC
• Phone: 614-257-2294
• Email: lindsay.hanes[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. Primary outcomes of this research effort include the development of composite measures or digital biomarkers to track functional recovery over time and predict duty or work status outcomes (return-to-full duty/work, limited duty/work restrictions or medical discharge/long-term disability).

2. Secondary outcomes of this research effort include characterization of motion assessment utility to predict reinjury risk and evaluate intervention effectiveness. In addition, exploratively, the investigators will determine biopsychosocial profiles of low back pain, and neck pain military populations to identify low back and neck pain phenotypes.

Participants will complete questionnaires and wear a motion monitor that will assess the participant's 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, and 1 year to complete a short series of questionnaires and a motion assessment test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

Control Cohort

• Ages 18-64

• Able to stand for at least 25 minutes

• Able to speak, read, and understand English

Low Back Pain Cohort

• Age 18-64

• Able to stand for at least 15 minutes

• Able to speak, read, and understand English

• Within the last 3 months, an episode of low back pain lasting longer than 7 days and/or seeing a health care provider for low back pain and/or on duty/work restriction due to low back pain.

Neck Pain Cohort

• Ages 18-64

• Able to stand for at least 15 minutes

• Able to speak, read, and understand English

• Within the last 3 months, an episode of neck pain lasting longer than 7 days and/or seeing a health care provider for neck pain and/or on duty/work restriction due to neck pain.

Operational Air crew Cohort

• Ages 18-55

• Able to stand for at least 25 minutes

• Able to speak, read, and understand English

• Ability to participate in cervical and back endurance training programs as part of standard operations

Exclusion Criteria:

Control Cohort

• Known pregnancy

• Within the last 3 months, back or neck pain lasting longer than 7 days and/or seeing a health care provider for low back or neck pain and/or on duty/work restriction due to low back or neck pain.

• Actively being treated by a medical provider for concussion or traumatic brain injury

• Known severe spine curvature or 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 a bracing or immobilization 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 bone loss or osteoporosis requiring medical treatment and physician-recommended physical restrictions

• Current open wounds on the body where the harnesses will be placed on the neck, head, back, or hips

• Current osteomyelitis or spine infection

• Any other reason that a treating physician, researcher, or participant determines it is unsafe for a patient to perform test

Low Back Pain Cohort

• Known pregnancy

• Current low back pain is the result of a traumatic injury (wreck, fall, etc.) that occurred within the last 3 months OR is positive for spine instability with imaging

• Has spinal fusion across 4 or more lumbar disc levels

• Currently being treated by a medical provider for concussion or traumatic brain injury

• Known severe spine curvature or 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

• Any known spinal instability or spine fractures within the last 6 months

• Current condition requiring a bracing or immobilization of the spine

• History of brain or spine cancer

• Currently or within the last 90 days, been treated for cancer with chemotherapy or radiation therapy

• Known severe bone loss or osteoporosis requiring medical treatment and physician-recommended physical restrictions

• Current open wounds on the body where the harnesses will be placed on the back or hips

• Current spine infection or osteomyelitis

• Any other reason that a treating physician, researcher, or participant determines it is unsafe for participant to perform test

Neck Pain Cohort

• Known pregnancy

• Current neck pain is the result of a traumatic injury (wreck, fall, etc.) that occurred within the last 3 months OR is positive for spine instability with imaging

• Has spinal fusion across 4 or more cervical disc levels

• Has an occipital-cervical fusion

• Currently being treated by a medical provider for concussion or traumatic brain injury

• Known severe spine curvature or 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

• Any known spinal instability or spine fractures within the last 6 months

• Current condition requiring a bracing or immobilization of the spine

• History of brain or spine cancer

• Currently or within the last 90 days, been treated for cancer with chemotherapy or radiation therapy

• Known severe bone loss or osteoporosis requiring medical treatment and physician-recommended physical restrictions

• Current open wounds on the body where the harnesses will be placed on the neck or head

• Current spine infection or osteomyelitis

• Any other reason that a treating physician, researcher, or participant determines it is unsafe for participant to perform test

Operational Air crew Cohort

• Known pregnancy

• Current neck and/or low back pain is the result of a traumatic injury (wreck, fall, etc.) that occurred within the last 3 months OR is positive for spine instability with imaging

• Has spinal fusion across 4 or more lumbar disc levels

• Currently being treated by a medical provider for concussion or traumatic brain injury

• Known severe spine curvature or 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

• Any known spinal instability or spine fractures within the last 6 months

• Current condition requiring a bracing or immobilization of the spine

• History of brain or spine cancer

• Currently or within the last 90 days, been treated for cancer with chemotherapy or radiation therapy

• Known severe bone loss or osteoporosis requiring medical treatment and physician-recommended physical restrictions

• Current open wounds on the body where the harnesses will be placed on the back or hips

• Current spine infection or osteomyelitis

• Any other reason that a treating physician, researcher, or participant determines it is unsafe for participant to perform test

Related Conditions & MeSH terms

• Low Back Pain
• Neck Pain

Locations

Country	Name	City	State
United States	Uniformed Services University	Bethesda	Maryland
United States	Peterson Space Force Base	Colorado Springs	Colorado
United States	Schriever Space Force Base	Colorado Springs	Colorado
United States	The Ohio State University	Columbus	Ohio
United States	Eglin Air Force Base	Eglin Air Force Base	Florida
United States	Holloman Air Force Base	Holloman Air Force Base	New Mexico
United States	Joint Base Langley- Eustis Air Force Base	Langley Air Force Base	Virginia
United States	Luke Air Force Base	Luke Air Force Base	Arizona
United States	Seymour-Johnson Air Force Base	Seymour Johnson Air Force Base	North Carolina
United States	Wright-Patterson Air Force Research Laboratory	Wright-Patterson Air Force Base	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predict Work Status	To track functional recovery over time that can predict duty or work status.	2030
Secondary	Predict Reinjury Risk	To track reinjury risk and evaluate intervention effectiveness to predict reinjury risk.	2030