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

NCT04081896 | Recruiting

• 1 other identifier: Spine Exercise
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Change in spine extensor muscle cross sectional area (cm2)

  3 months

• change in spine extensor muscle fatty infiltration (%)

  3 months

Other Outcomes (2)

• Change in medication usage (category)

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

• Surgery (%)

  6 months, 1 year, and 2 years

Study Arms (2)

In Clinic Rehabilitation

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

Other: Exercise

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)

Other: Exercise

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.

In Clinic Rehabilitation; Online Rehabilitation

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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).

You may qualify if:

• over 18 years of age
• under 89 years of age
• Patients who have been prescribed physical rehabilitation for management of spine pain

You may not qualify if:

• 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

Sponsors & Collaborators

• SpineZone Medical Fitness, Inc: lead
• University of California, San Diego: collaborator

Study Sites (1)

SpineZone

San Diego, California, 92108, United States

RECRUITING

Related Publications (1)

• Raiszadeh K, Tapicer J, Taitano L, Wu J, Shahidi B. In-Clinic Versus Web-Based Multidisciplinary Exercise-Based Rehabilitation for Treatment of Low Back Pain: Prospective Clinical Trial in an Integrated Practice Unit Model. J Med Internet Res. 2021 Mar 18;23(3):e22548. doi: 10.2196/22548.

  PMID: 33734088 DERIVED

MeSH Terms

Conditions

Neck Pain; Low Back Pain; Scoliosis; Thoracic Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bahar Shahidi, P.T., Ph.D.

  University of California, San Diego

  STUDY DIRECTOR

Central Study Contacts

Kamshad Raiszadeh, M.D.

CONTACT

858-337-6909; kam@spinezone.com

Jon Wu, P.A.

CONTACT

858-337-6909; jonwu@spinezone.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: September 9, 2019
• Study Start: April 15, 2019
• Primary Completion: April 15, 2026
• Study Completion (Estimated): April 15, 2029
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)