Recruiting

Rehabilitation Program

Sponsor:

SpineZone Medical Fitness, Inc

Code:

NCT04081896

Conditions

Neck Pain

Low Back Pain

Scoliosis

Thoracic Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

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.

Conditions

Neck Pain

Low Back Pain

Scoliosis

Thoracic Injuries

Study ID

NCT04081896

Start date

Apr 15, 2019

Status verified date

Nov, 2024

Completion date

Apr 15, 2029

Anticipated

Primary completion date

Apr 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

In Clinic Rehabilitation

Participants who are undergoing supervised exercise based rehabilitation in the SpineZone clinic

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)

Interventions

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 measure

  • Change in pain: Visual Analogue Scale (VAS), 0-100mm [ Time Frame: 3 months, 6 months, 1 year, and 2 years ]
  • Change in disability (%) [ Time Frame: 3 months, 6 months, 1 year, and 2 years ]
  • Change in quality of life [ Time Frame: 3 months, 6 months, 1 year, and 2 years ]
  • Change in strength (lbs*deg) [ Time Frame: 3 months, 6 months, 1 year, and 2 years ]
  • Change in Range of Motion (deg) [ Time Frame: 3 months, 6 months, 1 year, and 2 years ]

Central Contacts and Locations

Central contacts

Kamshad Raiszadeh, M.D.

858-337-6909kam@spinezone.com

Jon Wu, P.A.

858-337-6909jonwu@spinezone.com

Locations

SpineZone

Recruiting

San Diego, California, United States, 92108

Contacts

Kamshad Raiszadeh, M.D

8583376909kam@spinezone.com

More Information

Sponsor

SpineZone Medical Fitness, Inc

Last update posted

Nov 29, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SpineZone Medical Fitness, Inc on 2024-11-29.