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

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ClinicalTrials.gov Identifier: NCT04081896
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Kamshad Raiszadeh, MD, SpineZone Medical Fitness, Inc

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.

Condition or disease Intervention/treatment
Neck Pain Low Back Pain Scoliosis Thoracic Injuries Other: Exercise

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Evaluation of the Effects of Exercise-based Rehabilitation in Individuals With Spine Pain
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : April 15, 2024
Estimated Study Completion Date : April 15, 2029

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
In Clinic Rehabilitation
Participants who are undergoing supervised exercise based rehabilitation in the SpineZone clinic
Other: Exercise

Exercise prescribed to participants includes personalized spine-specific strengthening exercises targeting the 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 repetitions but <20 repetitions their exercise load remains the same. If they are unable to reach 10 repetitions their exercise load is decreased 5-10% at their next visit. For each visit, pain and medication usage will be documented, and the strengthening protocol will be progressed as described above.

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.


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

Exercise prescribed to participants includes personalized spine-specific strengthening exercises targeting the 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 repetitions but <20 repetitions their exercise load remains the same. If they are unable to reach 10 repetitions their exercise load is decreased 5-10% at their next visit. For each visit, pain and medication usage will be documented, and the strengthening protocol will be progressed as described above.

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.





Primary Outcome Measures :
  1. Change in pain: Visual Analogue Scale (VAS), 0-100mm [ Time Frame: 3 months, 6 months, 1 year, and 2 years ]
    difference in VAS (in mm) between initial evaluation and endpoint

  2. Change in disability (%) [ Time Frame: 3 months, 6 months, 1 year, and 2 years ]
    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. Change in quality of life [ Time Frame: 3 months, 6 months, 1 year, and 2 years ]
    difference in EQ5-D (points) score between initial evaluation and endpoint

  4. Change in strength (lbs*deg) [ Time Frame: 3 months, 6 months, 1 year, and 2 years ]
    difference in spine extension torque as measured by isokinetic dynamometer between initial evaluation and endpoint

  5. Change in Range of Motion (deg) [ Time Frame: 3 months, 6 months, 1 year, and 2 years ]
    difference in total spine flexion and extension (in degrees) between initial evaluation and endpoint


Secondary Outcome Measures :
  1. Change in spine extensor muscle cross sectional area (cm2) [ Time Frame: 3 months ]
    Difference in cross sectional area of the multifidus and erector spinae muscles as measured via MRI between initial evaluation and endpoint

  2. change in spine extensor muscle fatty infiltration (%) [ Time Frame: 3 months ]
    difference in percentage of fat within the multifidus and erector spinae muscles as measured by T1-weighted MRI between initial evaluation and endpoint


Other Outcome Measures:
  1. Change in medication usage (category) [ Time Frame: 3 months, 6 months, 1 year, and 2 years ]
    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]

  2. Surgery (%) [ Time Frame: 6 months, 1 year, and 2 years ]
    Percentage of participants that cross over into a surgical intervention



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04081896


Contacts
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Contact: Kamshad Raiszadeh, M.D. 858-337-6909 kam@spinezone.com
Contact: Jon Wu, P.A. 858-337-6909 jonwu@spinezone.com

Locations
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United States, California
SpineZone Recruiting
San Diego, California, United States, 92108
Contact: Kamshad Raiszadeh, M.D    858-337-6909    kam@spinezone.com   
Sponsors and Collaborators
SpineZone Medical Fitness, Inc
University of California, San Diego
Investigators
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Study Director: Bahar Shahidi, P.T., Ph.D. University of California, San Diego

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Responsible Party: Kamshad Raiszadeh, MD, Principal Investigator, SpineZone Medical Fitness, Inc
ClinicalTrials.gov Identifier: NCT04081896     History of Changes
Other Study ID Numbers: Spine Exercise
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient data will only be accessible to SpineZone and collaborating research partners (UCSD)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Scoliosis
Back Pain
Low Back Pain
Neck Pain
Thoracic Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries