The Influence of a Protein Nutrition Beverage on Exercise-based Rehabilitation Outcomes in Individuals with Spine Pain.
NCT ID: NCT04829448
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
100 participants
INTERVENTIONAL
2022-03-16
2026-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Protein Intervention Group
Patients who receive the protein nutritional supplement as part of their prescribed exercise-based rehabilitation program.
Protein supplement
Protein supplement equivalent to Metagenics Ultrameal
Control Group
Patients who receive the prescribed exercise-based rehabilitation program, without protein supplement.
No interventions assigned to this group
Interventions
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Protein supplement
Protein supplement equivalent to Metagenics Ultrameal
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
89 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
Kamshad Raiszadeh, MD
OTHER
Responsible Party
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Kamshad Raiszadeh, MD
Chairman, Cheif Medical Officer
Principal Investigators
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Bahar Shahidi, PT, PhD
Role: STUDY_DIRECTOR
UCSD Orthopedic Surgery
Locations
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SpineZone
San Diego, California, United States
Countries
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Other Identifiers
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Protein and Exercise Outcomes
Identifier Type: -
Identifier Source: org_study_id