Low Back Pain Clinical Trial
Official title:
Evaluation of the Effects of Exercise-based Rehabilitation in Individuals With Spine Pain
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.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | April 15, 2029 |
Est. primary completion date | April 15, 2026 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | SpineZone | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
SpineZone Medical Fitness, Inc | University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in medication usage (category) | difference in frequency of analgesic medication usage between initial evaluation and endpoint: frequency will be aggregated according to the following categories: [None, <1/day, 1-2/day, 3+/day] | 3 months, 6 months, 1 year, and 2 years | |
Other | Surgery (%) | Percentage of participants that cross over into a surgical intervention | 6 months, 1 year, and 2 years | |
Primary | Change in pain: Visual Analogue Scale (VAS), 0-100mm | difference in VAS (in mm) between initial evaluation and endpoint | 3 months, 6 months, 1 year, and 2 years | |
Primary | Change in disability (%) | 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 | 3 months, 6 months, 1 year, and 2 years | |
Primary | Change in quality of life | difference in EQ5-D (points) score between initial evaluation and endpoint | 3 months, 6 months, 1 year, and 2 years | |
Primary | Change in strength (lbs*deg) | difference in spine extension torque as measured by isokinetic dynamometer between initial evaluation and endpoint | 3 months, 6 months, 1 year, and 2 years | |
Primary | Change in Range of Motion (deg) | difference in total spine flexion and extension (in degrees) between initial evaluation and endpoint | 3 months, 6 months, 1 year, and 2 years | |
Secondary | Change in spine extensor muscle cross sectional area (cm2) | Difference in cross sectional area of the multifidus and erector spinae muscles as measured via MRI between initial evaluation and endpoint | 3 months | |
Secondary | change in spine extensor muscle fatty infiltration (%) | difference in percentage of fat within the multifidus and erector spinae muscles as measured by T1-weighted MRI between initial evaluation and endpoint | 3 months |
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