The Impact of Paraspinal Muscle Atrophy in Spine Surgeries

May 25, 2025 updated by: Adnan Ahmad Elkamel, Assiut University

The Impact of Paraspinal Muscle Atrophy in Lumbar Spinal Fusion Outcomes

The goal of this observational study is to learn about the role of pre-operative paraspinal muscle atrophy in outcomes of lumbar spine fusion surgeries in patients with degenerative lumbar spine diseases. The main question it aims to answer is:

Does paraspinal muscle atrophy worsen lumbar spine fusion surgeries outcomes? Participants undergoing lumbar spine fusion surgeries as part of their treatment for degenerative lumbar spine diseases will answer survey questions about their low back pain and daily activities for 1 year.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Lumbar spine fusion surgery is a widely performed intervention worldwide with the rate steadily increasing. This trend reflects the growing burden of degenerative spinal disorders (DSD) and low back pain (LBP), which globally affect an estimated 266 million individuals (3.63% of the global population) each year. Socioeconomic factors are important risk aspects for lumbar pain and disability both directly and indirectly. Despite the widespread use of lumbar fusion surgery, outcomes are not uniformly successful. A significant proportion of patients experience poor postoperative results, with studies indicating that 33% of patients report treatment failure, including a 22% worsening rate after surgery for lumbar spinal stenosis. Factors associated with these poor outcomes include prolonged back pain duration (>12 months), prior spinal surgery, and advanced age (>70 years). One critical yet often overlooked factor contributing to poor outcomes is paraspinal muscle atrophy. The paraspinal muscles and vertebrae are interdependent tissues, and the health of these muscles plays a vital role in spinal stability and function. The multifidi, erector spinae, psoas, and quadratus lumborum muscles provide support for the lower back. Numerous studies have explored the degeneration or atrophy of back muscles and the reduction in back extensor muscle strength in patients with lower back pain. Patients with high lumbar muscularity and mild fatty infiltration ratio observed on preoperative MRI demonstrated more promising clinical and radiographic outcomes after lumbar interbody fusion. As the prevalence of degenerative spinal conditions continues to rise globally, understanding the role of paraspinal muscle health in surgical success is critical. By prioritizing patient selection based on modifiable risk factors, clinicians can enhance postoperative outcomes and mitigate the economic and clinical burdens associated with lumbar fusion surgery.

  • Sample Size Calculation:

Based on determining the main outcome variable, The estimated minimum required sample size is 55 patients.

The sample size was calculated using Epi-info version 7 software, based on the following assumptions:

Main outcome variable is to determine the impact of paraspinal muscle atrophy on lumbar spine fusion outcomes. Previous studies indicate a significant decrease in paraspinal muscle volume one year after surgery, dropping from 67.8% to 60.4%. This reduction correlates significantly with physical and mental outcomes, as well as pain levels. With 80% confidence, the margin of error for these findings is estimated to be within 3%.

- Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):

A. Preoperative:

  • Magnetic resonance imaging (MRI) of lumbar spine will be used to measure the total cross-sectional area (TCSA), functional cross-sectional area (FCSA) and fatty infiltration (FI) of erector spinae (ES), multifidus (MF) and psoas major (PM) at the level of diseased segment together with one level above & below using ImageJ software v1.54p.
  • plain X-rays will be used to measure local kyphotic angle and lumbar lordosis using Surgimap software v2.3.2.1.
  • Oswerty disability index Arabic version (ODI)
  • EuroQol-5-dimension 5-level Arabic version (EQ-5D-5L)
  • Visual analogue scale (VAS) B. Day one postoperative: Postoperative X-ray. C. Two weeks postoperative: Wound check. ODI, EQ-5D-5L, Visual Analogue Score. D. Six weeks postoperative: Wound check. ODI, EQ-5D-5L, Visual Analogue Score. E. Three months postoperative: ODI, EQ-5D-5L, Visual Analogue Score. F. Six months Postoperative: ODI, EQ-5D-5L, Visual Analogue Score, X-ray. G. One year Postoperative: ODI, EQ-5D-5L, Visual Analogue Score, X-ray, MRI if the patient is still complaining.

Study Type

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut University
        • Contact:
          • Vice President of graduate studies of Assiut University
          • Phone Number: +208822080150
          • Email: vp_grad@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing lumbar spinal fusion at Assiut University Hospitals, Department of Orthopedic surgery and Traumatology.

Description

Inclusion Criteria:

  • Patients with degenerative lumbar spine diseases undergoing lumbar spinal fusion.

Exclusion Criteria:

  • Long-level fusion ≥ 3 levels.
  • History of previous lumbar surgery.
  • Patients diagnosed with spondylolysis.
  • Other pathological conditions such as fractures, infections or tumors.
  • Uncontrolled comorbidities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswerty disability index Arabic version (ODI)
Time Frame: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.
The Oswestry Disability Index (ODI) translates low back pain disability into a numerical score for better understanding and communication. It's a questionnaire used to assess the impact of low back pain on a person's daily life, work, and ability to perform specific tasks. The ODI translates into a score from 0-100, with higher scores indicating greater disability. This score helps clinicians and researchers quantify the functional disability caused by low back pain.
Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS)
Time Frame: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.
A Visual Analogue Scale (VAS) is a measurement tool used to assess subjective experiences like pain or discomfort by having a person mark a point on a continuous line representing the range from "no pain" to "worst imaginable pain". Zero is equivalent to no pain and 10 indicates the worst possible pain.
Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.
Local kyphotic angle
Time Frame: Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.
In the context of degenerative spine disease, the local kyphotic angle refers to the increased forward curvature (kyphosis) at a specific level of the spine, often between two adjacent vertebral bodies. This local kyphosis can result from various factors, including vertebral collapse, disc degeneration, or changes in vertebral shape associated with aging. The local kyphotic angle is typically measured using X-ray images, with the angle formed by the upper and lower endplates of the vertebral bodies.
Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.
Lumbar lordosis
Time Frame: Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.
In degenerative lumbar spine disease, the normal inward curve of the lower back (lumbar lordosis) can change. This change can manifest as a loss of lordosis (flattening of the curve) or an increase in lordosis (excessive curve). It is measured using X-rays of lateral view of lumbar spine by using the lumbosacral angle (LSA), which is the angle between the top of L1 (the first lumbar vertebra) and the top of the sacrum. The Cobb angle method, using lines drawn along the superior endplates of L1 and S1.
Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.
EuroQol-5-dimension 5-level Arabic version (EQ-5D-5L)
Time Frame: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire measures health-related quality of life by assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. These levels range from "no problems" to "extreme problems" and the responses are combined to create a unique health state profile.
Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Ahmed S Abdelgawaad, Professor Doctor, Assiut University
  • Study Director: Amr H Ahmed, MD, Assiut University
  • Principal Investigator: Adnan A Elkamel, Bachelor degree, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 25, 2025

First Submitted That Met QC Criteria

May 25, 2025

First Posted (Actual)

June 4, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 25, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Paraspinal muscle atrophy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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