Effect of Protein Supplement on Paraspinal Muscles in Spine Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Spine Surgery

Intervention / Treatment
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* Drug: Three sachet of protein supplement to be mixed in with water used daily


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: protein supplement<br>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<br>* Three sachet of protein supplement to be mixed in with water used daily<br>* Other names: Pure-protein®;|
| Placebo Comparator: maltodextrin<br>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<br>* Three sachet of protein supplement to be mixed in with water used daily<br>* Other names: Pure-protein®;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protein supplement, Spine Surgery, Paraspinal Muscles