Evaluation of the Effects of a Rehabilitation Program in Individuals with Spine Pain

ConditionsNeck Pain Low Back Pain Scoliosis Thoracic Injuries

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-89

SponsorSpineZone Medical Fitness, Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

over 18 years of age

under 89 years of age

Patients who have been prescribed physical rehabilitation for management of spine pain

Disqualifiers

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

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Exercise
Other intervention
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.

Treatment groups

5,000 Participants

are divided into 2 treatment groups

Group A: In Clinic Rehabilitation1 intervention

Group B: Online Rehabilitation1 intervention

Trial outcomes

Primary outcomes

Change in pain: Visual Analogue Scale (VAS), 0-100mm

difference in VAS (in mm) between initial evaluation and endpoint

Time frame

3 months, 6 months, 1 year, and 2 years

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

Time frame

3 months, 6 months, 1 year, and 2 years

Change in quality of life

difference in EQ5-D (points) score between initial evaluation and endpoint

Time frame

3 months, 6 months, 1 year, and 2 years

Change in strength (lbs*deg)

difference in spine extension torque as measured by isokinetic dynamometer between initial evaluation and endpoint

Time frame

3 months, 6 months, 1 year, and 2 years

Secondary outcomes

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

Time frame

3 months

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

Time frame

3 months

Other outcomes

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: \[None, \<1/day, 1-2/day, 3+/day\]

Time frame

3 months, 6 months, 1 year, and 2 years

Surgery (%)

Percentage of participants that cross over into a surgical intervention

Time frame

6 months, 1 year, and 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SpineZone Medical Fitness, Inc

Lead sponsor

University of California, San Diego

Collaborator

Source ClinicalTrials.gov

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