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

• ClinicalTrials.gov Identifier: NCT04829448
• Recruitment Status: Not yet recruiting
• First Posted: April 2, 2021
• Last Update Posted: December 17, 2021
• Sponsor: Kamshad Raiszadeh, MD
• Collaborator: University of California, San Diego
• Information provided by (Responsible Party): Kamshad Raiszadeh, MD, SpineZone Medical Fitness, Inc

Study Description

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

Detailed Description:

Low back pain manifests itself clinically with pain, loss of strength, difficulty with normal posture, and decreased range of motion. In as many as 60-85% cases, LBP will become a chronic condition, requiring long term care, and even surgery.

Conservative therapy is typically administered until it's no longer a viable option, after which surgical options are considered. Conservative therapy includes physical therapy, medication, steroid injections etc. Physical therapy and exercises are especially central to conservative therapy. Numerous exercise and therapy protocols have been designed with the goal to improve low back muscle strength, thereby alleviating symptoms, and potentially underlying cause of the pathology.

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.

The project specifically aims to assess the effect of ensuring adequate nutritional availability of protein, as protein shake, as part of their standard care for treatment of low back pain typically 4-12 weeks duration. In this experiment, we will compare muscle structure and health and correlate improvements with patient-specific characteristics such as demographics, medical history, medication usage, treatment expectations, and symptom severity. Subsequently, this information will enable us to gain valuable insight into physiological response of pathological tissue, and potentially, develop optimal exercise plans to maximally benefit these patients.

AIMS OF THE STUDY

• To evaluate the adherence and compliance of patients taking a protein nutritional supplement in this patient population.
• To evaluate the effectiveness of protein nutritional supplementation on improving clinical outcomes.
• Identify patients (based on patient specific predictors who are most likely to succeed with the addition of nutritional supplementation. The goal of this project is to assess the impact of a nutritional protein supplement on clinical outcomes in individuals with spine pain.

RESEARCH PARTICIPANTS We will recruit up to 100 individuals with LBP of > 3months duration that have been identified by the care providers (ie. Primary care physical, orthopaedic surgeon, or other) to be appropriate and safe for participation in a physical rehabilitation program with nutritional supplementation at SpineZone.

Upon initial evaluation at the SpineZone clinic with a Physical Therapist, participants will be offered the opportunity participate in the study and may receive the protein supplement as part of their standard care. Potentially interested patients will be screened by inclusion and exclusion criteria and as such, written informed consent will be obtained from each patient.

Patients will then be randomly assigned to the treatment (protein supplement) or control group (no protein supplement) and commence their prescribed rehabilitation treatment as per therapist recommendation. Individuals in the randomly assigned supplementation group will be provided the supplement and will be instructed on its use (dosage and frequency).

CONSENT All guidelines for proper consenting will be observed. Consenting will be done in a private room prior to any procedures being performed. Patients will be given ample time to review the document and ask questions. All study procedures will be thoroughly explained and all questions will be answered. Patients will not be placed under any pressure to participate in the study. Consent forms will be obtained by the investigators of the study and/or the study coordinator in the SpineZone clinics.

Withdrawal from the study: If the patient decides at any point to withdraw from the study, they can do so without any of the benefits to which they are entitled changing.

RISK/BENEFITS RATIO The risks to the patients will be minimal. Although there is, future patients may benefit from improvements to surgical procedures and more effective rehabilitation programs which will be derived from patient outcomes.

DATA PRIVACY AND CONFIDENTIALITY A confidentiality breach is a risk associated with data review research; however every measure will be instituted to ensure that patient information is kept confidential. Data analysis worksheets will be kept separate from EMR records. No subject public health information will be collected or shared.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Kamshad Raiszadeh, MD; 858-337-6909; kam@spinezone.com

Contact: Sarah Northway, MS; 844-316-7979 ext 1049; sarah.northway@spinezone.com

Locations

United States, California

SpineZone

San Diego, California, United States, 92108

Sponsors and Collaborators

Kamshad Raiszadeh, MD

University of California, San Diego

Investigators

• Study Director: Bahar Shahidi, PT, PhD; UCSD Orthopedic Surgery

More Information

• 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
• 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).

• 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:

Low Back Pain; Back Pain; Pain; Neurologic Manifestations