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

NCT04829448 | Suspended

• 1 other identifier: Protein and Exercise Outcomes
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Protein Supplement; Exercise-based Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Muscle size

  Change in spine extensor muscle cross sectional area (cm2)

  3 months, 6 months, 1 year, 2 years

Secondary Outcomes (4)

• Symptom inference - change in pain. Visual Analogue Scale (VAS), 0-100mm

  3 months, 6 months, 1 year, 2 years

• Change in disability

  3 months, 6 months, 1 year, 2 years

• Patient Goal Achievement

  3 months, 6 months

• Change in strength (lbs*deg)

  3 months, 6 months, 1 year, 2 years

Study Arms (2)

Protein Intervention Group

EXPERIMENTAL

Patients who receive the protein nutritional supplement as part of their prescribed exercise-based rehabilitation program.

Dietary Supplement: Protein supplement

Control Group

NO INTERVENTION

Patients who receive the prescribed exercise-based rehabilitation program, without protein supplement.

Interventions

Protein supplement DIETARY_SUPPLEMENT

Protein supplement equivalent to Metagenics Ultrameal

Protein Intervention Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kamshad Raiszadeh, MD: lead
• University of California, San Diego: collaborator

Study Sites (1)

SpineZone

San Diego, California, 92108, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bahar Shahidi, PT, PhD

  UCSD Orthopedic Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman, Cheif Medical Officer

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 2, 2021
• Study Start: March 16, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)