Effect of Protein Supplement on Paraspinal Muscles in Spine Surgery

Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04300517
• Other study ID #: 1398/802
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spine Surgery

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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