Clinical trial NCT04300517: Effect of Protein Supplement on Paraspinal Muscles in Spine Surgery
Official title: The Effect of Protein Supplement on Paraspinal Muscles in Patients Undergoing Lumbar Posterior Spine Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Surgery
Keywords: Protein supplement
Spine Surgery
Paraspinal Muscles
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: The thickness of the paraspinal muscles in CT scan
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Degree and severity of paraspinal muscle mass atrophy in CT scan
timeFrame: baseline, and 3 months after surgery
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital
Study officials:
References: