Effects of a Targeted Nutritional Supplement on Muscle Volume and Function After Posterior Lumbar Spine Surgery: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Paraspinal muscle volume
研究概览
简要总结
The goal of this clinical trial is to prospectively evaluate the effects of essential amino acid (EAA) supplementation on the volume and structure of the muscles surrounding the spine (paraspinal musculature). The main questions it aims to answer are:
- Does EAA supplementation preserve paraspinal muscle volume (PMV) and influence changes to spinal alignment following lumbar spine surgery?
- Does preserving paraspinal muscle volume (PMV) improve post-operative functional status?
- Does preserving PMV reduce post-operative complications, pain, and opioid consumption?
Participants will be asked to:
- Consume either EAA supplement or placebo (alanine) twice daily for one week before and two weeks after lumbar spine surgery
- Record pain levels and medication use in a diary
- Perform functional assessments at routine follow-up visits after surgery
- Undergo blood draws to monitor nutrition status and health
- Undergo one spine magnetic resonance imaging (MRI) before surgery as part of routine surgical planning
- Undergo one additional spine MRI after surgery to monitor PMV after treatment
Researchers will compare the group that consumed EAA supplement and the group that consumed placebo to see if there is a difference in paraspinal muscle volume changes and measures of spinal alignment, functional abilities, pain levels, and opioid use.
详细描述
This study is a randomized, placebo-controlled, double-blinded, single-center clinical trial to elucidate the effects of perioperative essential amino acid nutritional supplementation in pursuit of the following aim and covariates:
Specific Aim 1: Preserve paraspinal muscle volume and assess impact on spine sagittal balance through measurement of radiographic parameters. Paraspinal muscle atrophy following lumbar spine surgery has been correlated with worse clinical outcomes. It is still not understood whether iatrogenic denervation, immobilization, or nutritional deficiencies lead to the reduced volume in the paraspinal muscles. Investigators will utilize pre- and post-operative MRI scans to quantify changes in paraspinal and psoas muscle cross-sectional area and fatty infiltration, and measure sagittal vertical axis, pelvic incidence, lumbar lordosis, and pelvic tilt, as muscle quality has been correlated with spine balance and degeneration, as well as bone quality.
Specific Aim 2: Assess clinical outcomes postoperatively to determine any possible effect of paraspinal muscle volumes on variability in functional status. Functional assessments will be made using established, validated clinical outcomes measures at baseline and up to 2 years postoperatively. Postoperative adverse events will be recorded throughout the duration of the study, as well as markers of nutritional status using a validated dietary questionnaire and blood sampling. Results will be compared between treatment and control groups to determine if functional status is associated with variability in outcomes related to preservation of native paraspinal muscle volume postoperatively.
Specific Aim 3: Evaluate postoperative pain and opioid consumption postoperatively to determine any possible effect of pain on variability in paraspinal muscle volumes. Patient-reported pain and opioid consumption will be evaluated perioperatively with a daily pain diary, clinician-administered pain assessments, and review of the state-controlled substances database (CURES). Pain ratings, mean morphine equivalents, time to baseline preoperative opioid consumption, and time to opioid discontinuation will be compared between treatment and control groups to determine any relationship between postoperative pain levels on variability in outcomes related to preservation of native paraspinal muscle volume following surgery.
Description of Procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of lumbar pathology requiring lumbar spine surgery without previous surgical intervention
- •Failure of more conservative treatment options
- •If undergoing fusion, surgery consists of short segment fusion of less than or equal to 5 levels without staged surgery
- •Provided voluntary written informed consent to participate in the study
- •Able to comply with all study procedures, including taking the assigned treatment or placebo as instructed and attending follow-up visits
- •No restrictions on the use of nutritional supplements or dietary modifications
- •Able to complete self-report questionnaires and assessments as required by the study protocol
- •Confirmed ambulatory status prior to surgery
排除标准
- •Comorbidities excluding the use of the proposed nutritional supplement or resulting in decreased serum albumin levels (phenylketonuria, galactosemia, nephrotic syndrome)
- •Diagnosis other than lumbar spine pathology requiring lumbar spine surgery
- •Non-ambulatory status
- •Uncontrolled endocrine disease; heart, kidney, liver, blood, or respiratory disease; peripheral vascular disease
- •Unable or unwilling to comply with study procedures, including taking the assigned treatment or placebo as instructed and attending follow-up visits.
- •History of congenital metabolic disease (e.g Hartnup disease, Phenylketonuria)
- •Active cancer
- •Active infection
- •Prior protein-calorie supplementation for other clinical indications
- •Recent treatment with anabolic steroids or oral corticosteroids for >1 week
- •History of chronic opioid consumption > 6 months
- •Testosterone or Androgen Supplementation
- •History of major head trauma
- •Pregnant/breastfeeding women
- •History of dementia
- •Vulnerable populations (minors, prisoners)
- •Lack of decision making capacity
- •BMI <18 or > 40
- •HbA1c > 7.0
- •Patients with pacemakers
- •Specific dietary restrictions or allergies that prevent the use of nutritional supplements or dietary modifications
- •Currently enrolled in another clinical trial involving interventions that may interfere with the outcomes of this study.
结局指标
主要结局
Paraspinal muscle volume
时间窗: Preoperative lumbar MRI at 6 months-6 weeks prior to surgery, postoperative lumbar MRI at 8-10 weeks after surgery.
Quantification of bilateral paraspinal muscle cross-sectional area in cm\^2 measured with Visage Imaging (San Diego, California) software by two experienced musculoskeletal radiologists marking the borders of these muscles at a standardized spinal level in the lumbar spine. Psoas muscle cross-sectional areas and body height will be used for standardization of body type. Intraclass correlation coefficient between observers will be evaluated and interpreted according to the following guidelines: 0-0.40 poor; 0.41-0.60, moderate; 0.61-0.80, good; and 0.81-1.00 excellent.
次要结局
- Percentage of paraspinal muscle fatty infiltration(Preoperative lumbar MRI at 6 months-6 weeks prior to surgery, postoperative lumbar MRI at 8-10 weeks after surgery.)
- Paraspinal muscle qualitative fatty infiltration grading (simplified 3-tier classification)(Preoperative lumbar MRI at 6 months-6 weeks prior to surgery, postoperative lumbar MRI at 8-10 weeks after surgery.)
- Sagittal spinopelvic alignment (angles measured in degrees)(Preoperative lumbar MRI at 6 months-6 weeks prior to surgery, postoperative lumbar MRI at 8-10 weeks after surgery.)
- Low back pain (Oswestry disability index 2.1A, total score)(Baseline visit (6 weeks-1 week preoperatively) and 2-week, 6-week, and 12-week follow up visits.)
- Health-related quality of life (36-Item Short Form Health Survey total and subsection scores)(Baseline visit (6 weeks-1 week preoperatively) and 2-week, 6-week, and 12-week follow up visits.)
- Self-reported capability to perform activities (PROMIS Physical Function total score)(Baseline visit (6 weeks-1 week preoperatively) and 2-week, 6-week, and 12-week follow up visits.)
- Self-reported perceived problems (EuroQol-5 Dimension 5 Levels (EQ-5D-5L) total and subsection scores)(Baseline visit (6 weeks-1 week preoperatively) and 2-week, 6-week, and 12-week follow up visits.)
- 6-minute walk test (distance in meters)(Baseline visit (6 weeks-1 week preoperatively) and 2-week, 6-week, and 12-week follow up visits.)
- 5 repetitive sit-to-stand (time in seconds)(Baseline visit (6 weeks-1 week preoperatively) and 2-week, 6-week, and 12-week follow up visits.)
- Self-reported pain levels (Numeric Pain Rating Scale)(Daily recordings starting 1 week prior to surgery up until 2 weeks after surgery or until time of opioid medication discontinuation for a maximum of 1 month after surgery, whichever is sooner.)
- Hospital length of stay (time in days)(Day of surgery until date of discharge)
- Incidence of postoperative complications (number of occurrences)(Baseline visit (6 weeks-1 week preoperatively), immediately preoperative on day of surgery, and 2-week, 6-week, and 12-week follow up visits.)
- Clinician-administered pain rating (Visual Analog Scale pain score)(Baseline visit (6 weeks-1 week preoperatively), immediately preoperative on day of surgery, and 2-week, 6-week, and 12-week follow up visits.)
- Patient-reported pain medication use (measured in mean morphine equivalents)(Starting 1 week prior to surgery up until 2 weeks after surgery or until time of opioid medication discontinuation for a maximum of 1 month after surgery, whichever is sooner.)
- Prescription opioid consumption (measured in mean morphine equivalents)(Baseline visit (6 weeks-1 week preoperatively), immediately preoperative on day of surgery, and 2-week, 6-week, and 12-week follow up visits.)
- Time to opioid discontinuation (time in days)(Day of surgery up until 2 weeks after surgery or until time of opioid medication discontinuation for a maximum of 1 month after surgery, whichever is sooner.)
- Time to less than baseline opioid consumption (time in days)(Baseline visit (6 weeks-1 week preoperatively) up until 2 weeks after surgery or until time of opioid medication discontinuation for a maximum of 1 month after surgery, whichever is sooner.)
研究者
Sohaib Zafar Hashmi
Assistant Clinical Professor, Department of Orthopaedic Surgery
University of California, Irvine