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

Part of paid clinical trials in San Diego, California.

Sponsor
SpineZone Medical Fitness, Inc
Study ID
NCT04081896
Status
Recruiting
Apply to this trial

Conditions

  • Low Back Pain
  • Neck Pain
  • Scoliosis
  • Thoracic Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Exercise — OTHER
    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.

Study Details

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.

Key Dates

Start date
Apr 15, 2019
Status verified
Nov 2024
Primary completion
Apr 15, 2026
Completion
Apr 15, 2029

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: In Clinic Rehabilitation
    Participants who are undergoing supervised exercise based rehabilitation in the SpineZone clinic
  • Arm: Online Rehabilitation
    Participants who will be undergoing online-based coaching and exercise as prescribed via telephone, online chat, or web-based interactions with SpineZone rehabilitation staff (physical therapists and physicians)

Primary Outcome Measure

Change in pain: Visual Analogue Scale (VAS), 0-100mm [ Time Frame: 3 months, 6 months, 1 year, and 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SpineZoneSan DiegoCalifornia92108
Kamshad Raiszadeh, M.D
[email protected]
8583376909

Find similar trials in San Diego, CA

By research site
SpineZone· San Diego, CA

Related Studies