Effect of Protein Supplement on Paraspinal Muscles in Spine Surgery

The Effect of Protein Supplement on Paraspinal Muscles in Patients Undergoing Lumbar Posterior Spine Fusion Surgery

Protein intake in spinal fusion surgery can prevent paraspinal muscle atrophy by maintaining muscle mass, regeneration, and growth. Also, by reducing the amount of pseudarthrosis, pain and disability can have a positive effect on recovery.

The high prevalence of this type of surgery, the instability and degeneration of adjacent surfaces of fused sections, lumbar muscle atrophy, increased muscle tissue fat, and negative impact on patient recovery, also with regard to the fact that research has so far aimed to determine The effect of protein supplementation on para-spinal muscles has not been studied in patients undergoing posterior lumbar spine fusion surgery, therefore clinical trials are necessary. In this trial patients undergoing elective posterior spine fusion surgery are divided into two groups of intervention or control.

Study Overview

• Status: Completed
• Conditions: Spine Surgery
• Intervention / Treatment: Drug: Three sachet of protein supplement to be mixed in with water used daily

Detailed Description

A randomized, double blind, controlled trial will be conducted in patients undergoing elective posterior spine fusion surgery in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 80 eligible posterior spine fusion surgery patients, aged ≥ 18 years. Intervention patients will be received 36 grams of protein supplement along with diet containing 1.2 g/kg/day of protein for 30 days after surgery and control patients will be received maltodextrin along with diet containing 1.2 g/kg/day of protein 30 days after surgery. Patients will be evaluated for occurrence of paraspinal muscles after 3 months surgery

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients 18-65 years
• Body mass index 18.5-30
• Candidate for the elective posterior spine fusion
• Without history of severe liver disorder
• Without history of Kidney disorder
• Without history of diabetes
• Without history of trauma and fracture of the vertebral
• Without history of osteoporosis
• Without history of Gastrointestinal malabsorption
• Without history of Parathyroid gland disorders
• Without taking medications that affect the metabolism of bone, such as calcitonin, bisphosphonate, corticosteroid
• No smoking
• Without history of neuromuscular diseases such as dystrophies and neurological disorders

Exclusion Criteria:

• Allergy or intolerance to protein or maltodextrine supplement
• Unwillingness to continue cooperation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: protein supplement; Intervention patients will be received protein diet (1.2 g/kg/day) and protein supplement (36 g/day) for 1 month after surgery.	Drug: Three sachet of protein supplement to be mixed in with water used daily; Three sachet of protein supplement to be mixed in with water used daily; Other Names: Pure-protein®
Placebo Comparator: maltodextrin; Control patients will be received protein diet (1.2 g/kg/day) and maltodextrin for 1 month after surgery.	Drug: Three sachet of protein supplement to be mixed in with water used daily; Three sachet of protein supplement to be mixed in with water used daily; Other Names: Pure-protein®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The thickness of the paraspinal muscles in CT scan	The thickness of the paraspinal muscles (multifidus, erector spinae, Quadratus, and Lumborum) in CT scan	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree and severity of paraspinal muscle mass atrophy in CT scan	Degree and severity of paraspinal muscle mass atrophy (multifidus, erector spinae, Quadratus, and Lumborum) in CT scan	baseline, and 3 months after surgery

Collaborators and Investigators

• Sponsor: Shahid Beheshti University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 25, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Spine Surgery; Protein supplement; Paraspinal Muscles
• Other Study ID Numbers: 1398/802

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No