Clinical trial NCT04081896: Evaluation of the Effects of a Rehabilitation Program in Individuals with Spine Pain
Official title: Evaluation of the Effects of Exercise-based Rehabilitation in Individuals with Spine Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neck Pain
Low Back Pain
Scoliosis
Thoracic Injuries
Lead sponsor: SpineZone Medical Fitness, Inc
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2019-09-09
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - Individuals between the ages of 18-89 who are seeking, or have been prescribed physical rehabilitation as a conservative management strategy for a complaint of spine pain (including, but not limited to neck pain, low back pain, thoracic spine pain, or scoliosis).

Brief summary: SpineZone is an innovative physical therapy program with its focus on treatment of cervical, thoracic, and lumbar conditions through the use of a multi-disciplinary, technology enabled platform. Standard physical therapy modalities including psychologically informed physical therapy are employed in addition to online coaching with a fundamental tenant of core strengthening. Treatments are tracked and modified in a multi-disciplinary format taking all radiographic studies into direct consideration. The goal of this study is to utilize a registry of participants undergoing either in-clinic or online rehabilitation treatment for spine pain at the SpineZone clinical in order to understand the clinical outcomes and costs of different rehabilitation modalities in this patient population.

Detailed description: The key objectives for this registry are to 1) identify magnitudes of clinical improvements with this specific specialized rehabilitation program in its various formats (in-clinic vs online), in individuals with or without spine pain for comparison to literature-based standard of care values for other conservative care protocols, 2) to identify average value of this treatment approach based on cost assessment, 3) to identify which patients (based on patient-specific predictors) are most likely to succeed with this specialized program and 4) to identify targets for improvement and optimization of patient care any necessary modifications to the industry's standard for care protocol. The goal of this project is to assess the impact of a standardized program based on core strengthening using technologic monitoring in a multidisciplinary format.

This registry of data will not contain individual identifiers.

The study population is comprised of skeletally mature patients, both male and female, from a wide variety of ethnicities representative of the typical population presenting with spinal conditions, pain, or seeking prevention of future injury. There are no child participants, as they are not candidates for the type of programs under investigation.

All data relating to the patient's physical therapy, diagnosis, co-morbidies, medical history, medications etc., will be used for analysis.

STUDY METHODS:

1. Describe how the data will be identified:

   Approved SpineZone staff will extract relevant outcomes data from the Electronic Medical Records system housed on a secure server. Identifiers will be stripped from the data, and claims will be indexed using Coding processes. Investigators will not have access to the pre-coded identifiers. Age, but not date of birth will be used, but no patients over the age of 89 will be included, thus it will not be an identifier. All systems used to store and view the data will be secure, with password protections and login access required. Once initial data extraction and de-identification is complete, the de-identified data will be stored on secure servers in a HIPAA compliant environment, and only transferred for biostatistics analytics through encrypted and password protected email to approved individuals (i.e. research biostatisticians) following a data use agreement.
2. Data that will be used:

Outcome variables: Validated questionnaire-based outcomes including but not limited to: VAS (visual analogue scale), ODI (oswestry disability index) for Low Back Pain, NDI (neck disability index) for neck pain, PSFS (patient specific functional scale), SBST (STarT Back Screening Tool), Hospital Anxiety and Depression Scale (HADS), medication usage (type, frequency), number of visits, progression to surgery (yes, no), dropout rates and reasons, Online compliance matrix(including access to educational material, log in rates, and self-reporting of compliance with workout regimen); physical examination measurements: strength and ROM measurements, and cost (based on procedural codes).

Predictor variables: Demographic, medical history, and treatment-specific variables including but not limited to: age, gender, ethnicity, diagnosis code (ICD-9/10), SpineZone rehabilitation diagnosis, treatment type, treatment history, radiologic diagnosis, duration of symptoms, postural factors, questionnaire-based pre-treatment disability, psychosocial status, prior treatments, concurrent treatments (e.g., nutrition, mindfulness), and pain scores.

d) Who will identify data to be reviewed:

SpineZone clinical staff and Principal Investigator

CONFIDENTIALITY OF DATA:

Data that is identified by the primary investigator for review will be additionally checked for any identifiers and stripped prior to analysis by biostatisticians. This data will be stored in two places. Initially, the de-identified data will be stored in the biostatistician's system for analysis. Once initial analysis is complete, the data will be loaded into a secure server with physical 24-hour security preventing unauthorized access to the hardware, with access to data only allowed through HTTPS login or through a direct and secure tunnel. Only investigators will have access to the login information.

Within two months of completion of the study, biostatisticians copy of the data will be destroyed. The data will be maintained in the secure hosted environment indefinitely.

Data will be transmitted with either password protection or PGP encryption on biostatistician computers. These computers and associated hardware are maintained in a secured facility with no public access. Computers are password protected and after 30 minutes of inactivity require the user to login again. Data and programs are backed up on a daily basis during the active phase of any project. Internet access is firewall protected. Anti-virus software is maintained (McAfee) with all incoming and outgoing documents scanned for viruses. Additionally, a scan of all files is performed daily.

Data storage will be on secure servers at a 24-hour guard facility, on windows server systems with updated enterprise virus protection software from Symantec. The database will only be accessible through an HTTPS log-in, with user-based access levels that ensure only personnel authorized by the principal investigator can gain access to the system. Any access will be tracked through a log of historical events that will track what user viewed or manipulated what data at any time.

Systems, security policies, and access logs will all be available for audit and review by the Principal Investigator at any time.

CONSENT:

Consent will be obtained in clinic, or through a form on an online portal for patients participating in the online treatment arm.

RISKS AND BENEFITS:

Risks: A confidentiality breach is a risk associated with data review research, however every measure will be instituted to ensure that patient information is kept confidential. Data analysis worksheets will be kept separate from EMR records. No subject PHI will be collected or shared.

Benefits: The participants are not likely to receive any benefit from the proposed research; however, society and investigators will benefit from the knowledge gained.

STATISTICAL CONSIDERATIONS:

As this is intended to be a data registry, no current statistical analyses are being proposed. Independent sub-studies utilizing data from this registry will be required to provide power analyses and proposed sample sizes necessary to carry out the objectives of the individual research question.

Data will be analyzed for individual sub-studies by biostatisticians located at the University of California, San Diego. All individuals participating in data analysis will be trained in research compliance, ethics, and will follow regulations according to the approved data use agreements in place.

Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* under 89 years of age
* Patients who have been prescribed physical rehabilitation for management of spine pain

Exclusion Criteria:

* under 18 years of age
* over 89 years of age
* Patients who are unable or medically unsafe to participate in physical rehabilitation for management of spine pain as determined by the prescribing physician

Primary outcomes:
measure: Change in pain: Visual Analogue Scale (VAS), 0-100mm
timeFrame: 3 months, 6 months, 1 year, and 2 years
measure: Change in disability (%)
timeFrame: 3 months, 6 months, 1 year, and 2 years
measure: Change in quality of life
timeFrame: 3 months, 6 months, 1 year, and 2 years
measure: Change in strength (lbs*deg)
timeFrame: 3 months, 6 months, 1 year, and 2 years
measure: Change in Range of Motion (deg)
timeFrame: 3 months, 6 months, 1 year, and 2 years
Secondary outcomes:
measure: Change in spine extensor muscle cross sectional area (cm2)
timeFrame: 3 months
measure: change in spine extensor muscle fatty infiltration (%)
timeFrame: 3 months
Other outcomes:
measure: Change in medication usage (category)
timeFrame: 3 months, 6 months, 1 year, and 2 years
measure: Surgery (%)
timeFrame: 6 months, 1 year, and 2 years
Locations:
city: San Diego
country: United States
facility: SpineZone
state: California
Study officials:
affiliation: University of California, San Diego
name: Bahar Shahidi, P.T., Ph.D.
role: STUDY_DIRECTOR
References:
citation: Raiszadeh K, Tapicer J, Taitano L, Wu J, Shahidi B. In-Clinic Versus Web-Based Multidisciplinary Exercise-Based Rehabilitation for Treatment of Low Back Pain: Prospective Clinical Trial in an Integrated Practice Unit Model. J Med Internet Res. 2021 Mar 18;23(3):e22548. doi: 10.2196/22548.