Spine Surgery
Conditions
Keywords
Protein supplement, Spine Surgery, Paraspinal Muscles
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
Interventions
DRUGThree 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
Sponsors
Shahid Beheshti University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The thickness of the paraspinal muscles in CT scan | 3 months after surgery | The thickness of the paraspinal muscles (multifidus, erector spinae, Quadratus, and Lumborum) in CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree and severity of paraspinal muscle mass atrophy in CT scan | baseline, and 3 months after surgery | Degree and severity of paraspinal muscle mass atrophy (multifidus, erector spinae, Quadratus, and Lumborum) in CT scan |
Countries
Iran
Outcome results
None listed