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The Influence of a Protein Nutrition Beverage on Exercise-based Rehabilitation Outcomes in Individuals With Spine Pain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04829448
Recruitment Status : Not yet recruiting
First Posted : April 2, 2021
Last Update Posted : December 17, 2021
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 exercise-based rehabilitation as well as patient education on a healthy lifestyle (sleep, nutrition, posture) are employed as part of the standard treatment. As nutrition is a key element in modulating muscle growth and function in response to exercise, providing patients with appropriate access to nutritional supplements that meet the metabolic demands of our exercise program are potentially important to our clinical outcomes.

Condition or disease Intervention/treatment Phase
Low Back Pain Dietary Supplement: Protein supplement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Influence of a Protein Nutrition Beverage on Exercise-based Rehabilitation Outcomes in Individuals With Spine Pain.
Estimated Study Start Date : February 2022
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Protein Intervention Group
Patients who receive the protein nutritional supplement as part of their prescribed exercise-based rehabilitation program.
Dietary Supplement: Protein supplement
Protein supplement equivalent to Metagenics Ultrameal

No Intervention: Control Group
Patients who receive the prescribed exercise-based rehabilitation program, without protein supplement.



Primary Outcome Measures :
  1. Muscle size [ Time Frame: 3 months, 6 months, 1 year, 2 years ]
    Change in spine extensor muscle cross sectional area (cm2)


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

  2. Change in disability [ Time Frame: 3 months, 6 months, 1 year, 2 years ]
    Difference in Oswestry Disability Index (ODI), between evaluation and end point

  3. Patient Goal Achievement [ Time Frame: 3 months, 6 months ]
    Patient Specific Functional Scale (PSFS), 0-10 points

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Seeking treatment for spinal conditions, pain or for the prevention of future injury
  • Ability to consume protein shake and follow storage, timing and preparation instructions
  • Indicated by a qualified health care provider to safely participate in an exercise-based rehabilitation program
  • Ability to read and comprehend the English language

Exclusion Criteria:

  • Certain medical conditions, diagnosis, physical or psychological or physical exam finding that precludes participation, medications, or contraindications for protein supplement

    • Individuals who are determined by their health care provider to be contraindicated for participation in an exercise-based rehabilitation program
    • Individuals with food allergies to animal based products, nuts, and/or eggs
    • Individuals with consumption preferences omitting non-vegan or vegetarian products
    • Taking protein supplements already
    • History of severe liver disorder
    • History of Kidney disorder
    • History of diabetes
    • History of Gastrointestinal malabsorption
    • History of Parathyroid gland disorders
    • Pregnant, postpartum up to six months, lactating, or intention to become pregnant

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): NCT04829448


Contacts
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Contact: Kamshad Raiszadeh, MD 858-337-6909 kam@spinezone.com
Contact: Sarah Northway, MS 844-316-7979 ext 1049 sarah.northway@spinezone.com

Locations
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United States, California
SpineZone
San Diego, California, United States, 92108
Sponsors and Collaborators
Kamshad Raiszadeh, MD
University of California, San Diego
Investigators
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Study Director: Bahar Shahidi, PT, PhD UCSD Orthopedic Surgery
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Responsible Party: Kamshad Raiszadeh, MD, Chairman, Cheif Medical Officer, SpineZone Medical Fitness, Inc
ClinicalTrials.gov Identifier: NCT04829448    
Other Study ID Numbers: Protein and Exercise Outcomes
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021
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
Keywords provided by Kamshad Raiszadeh, MD, SpineZone Medical Fitness, Inc:
Protein Supplement
Exercise-based Rehabilitation
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Pain
Neurologic Manifestations