NCT04081896 · SpineZone Medical Fitness, Inc
Evaluation of the Effects of a Rehabilitation Program in Individuals with Spine Pain
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Exercise
Exercise prescribed to participants includes spine-specific strengthening exercises targeting core musculature (i.e. Multifidus, Erector Spinae, Transversus Abdominus, Obliques, and Rectus Abdominus). The in-clinic exercise program recommends a minimum of 20 visits at 2 visits/week, with a goal of 24 total visits over a 12-week period. Exercise is progressed by 5-10% of their exercise load once they are able to do \>20 repetitions. If they are able to reach \>10 but \<20 repetitions, exercise load remains the same. If they are unable to reach 10 repetitions, exercise load is decreased 5-10% at their next visit. The online exercise program includes non-machine based home exercises targeting the same muscles of interest, and are personalized to each participant based on their home resources and comfort level. Concurrent interventions may or may not include nutrition education, mindfulness, cognitive behavioral therapy.
Primary outcome measures
Change in pain: Visual Analogue Scale (VAS), 0-100mm
Time frame: 3 months, 6 months, 1 year, and 2 years
difference in VAS (in mm) between initial evaluation and endpoint
Change in disability (%)
Time frame: 3 months, 6 months, 1 year, and 2 years
difference in Neck Disability Index (for neck pain participants) or Oswestry Disability Index (for Low Back Pain participants), or Scoliosis Research Society Outcomes questionnaire-22 (for Scoliosis participants) between initial evaluation and endpoint
Change in quality of life
Time frame: 3 months, 6 months, 1 year, and 2 years
difference in EQ5-D (points) score between initial evaluation and endpoint
Change in strength (lbs*deg)
Time frame: 3 months, 6 months, 1 year, and 2 years
difference in spine extension torque as measured by isokinetic dynamometer between initial evaluation and endpoint
Change in Range of Motion (deg)
Time frame: 3 months, 6 months, 1 year, and 2 years
difference in total spine flexion and extension (in degrees) between initial evaluation and endpoint
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Diego, California
Collaborators
University of California, San Diego
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 29, 2024 · Source of record for eligibility and locations