The Influence of a Protein Nutrition Beverage on Exercise-based Rehabilitation Outcomes in Individuals With Spine Pain.
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|ClinicalTrials.gov Identifier: NCT04829448|
Recruitment Status : Not yet recruiting
First Posted : April 2, 2021
Last Update Posted : December 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Dietary Supplement: Protein supplement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- Muscle size [ Time Frame: 3 months, 6 months, 1 year, 2 years ]Change in spine extensor muscle cross sectional area (cm2)
- 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
- Change in disability [ Time Frame: 3 months, 6 months, 1 year, 2 years ]Difference in Oswestry Disability Index (ODI), between evaluation and end point
- Patient Goal Achievement [ Time Frame: 3 months, 6 months ]Patient Specific Functional Scale (PSFS), 0-10 points
- 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
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
|Contact: Kamshad Raiszadeh, MDemail@example.com|
|Contact: Sarah Northway, MS||844-316-7979 ext firstname.lastname@example.org|
|United States, California|
|San Diego, California, United States, 92108|
|Study Director:||Bahar Shahidi, PT, PhD||UCSD Orthopedic Surgery|