Lower Back Muscle Size and Recovery After Lumbar Disc Herniation Surgery | NCT07768241 | Trialant

Not yet recruitingObservationalUpdated Aug 17, 2026

Lower Back Muscle Size and Recovery After Lumbar Disc Herniation Surgery

Association of Preoperative Psoas Muscle Index and Multifidus Muscle Area With Postoperative Quality of Recovery Assessed Using the Quality of Recovery-15 (QoR-15) in Patients Undergoing Surgery for Lumbar Disc Herniation: A Prospective Observational Study

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07768241
Lead Sponsor: Fatih Sultan Mehmet Training and Research HospitalOTHER
Overall Status: Not yet recruiting
Study Type: Observational
Enrollment: 100Estimated
Last Update Posted: Aug 17, 2026Actual
Start Date: Sep 2026Estimated
Primary Completion Date: Jun 2027Estimated
Completion Date: Jul 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Association of Preoperative Psoas Muscle Index and Multifidus Muscle Area With Postoperative Quality of Recovery Assessed Using the Quality of Recovery-15 (QoR-15) in Patients Undergoing Surgery for Lumbar Disc Herniation: A Prospective Observational Study
Brief Summary: Recovery after surgery for a herniated disc in the lower back differs from person to person. The size of the muscles around the lower spine may be related to recovery, but this relationship is not well understood.

The purpose of this observational study is to determine whether the size of two lower-back muscles, the psoas and multifidus muscles, measured on magnetic resonance imaging (MRI) scans obtained before surgery is related to recovery after surgery. The study will include 100 adults aged 18 to 75 years who are scheduled for elective surgery for lumbar disc herniation.

Participants will receive their usual anesthesia, surgery, and postoperative care. The study will not require any additional imaging, blood tests, medicines, or procedures. Researchers will use each participant's existing preoperative lumbar MRI scan to measure the psoas and multifidus muscles. Participants will complete the 15-item Quality of Recovery questionnaire (QoR-15) before surgery and again 24 hours, 48 hours, and 7 days after surgery. Researchers will also collect information routinely recorded during care, including pain scores, pain medicine use, nausea and vomiting, time spent in the recovery unit, time to first walking, and length of hospital stay.

The primary objective is to determine whether preoperative psoas muscle index and multifidus muscle cross-sectional area are independently associated with postoperative Quality of Recovery-15 (QoR-15) scores 24 hours after lumbar disc herniation surgery.

Conditions

The medical conditions and diseases this study investigates.

Postoperative Recovery
Lumbar Disc Herniation

Interventions

The treatments and procedures being evaluated in this study.

Preoperative Psoas and Multifidus Muscle Measurements

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Age between 18 and 75 years

Scheduled for elective surgery for lumbar disc herniation

American Society of Anesthesiologists physical status I-III

Availability of a preoperative lumbar MRI obtained as part of routine clinical care

Scheduled to undergo surgery under general anesthesia

Sufficient cognitive and communication ability to understand and complete the quality of recovery (QoR-15) questionnaire

Willingness to participate and provision of written informed consent

Exclusion Criteria:

Emergency surgery

Revision lumbar spine surgery

Surgery for a spinal tumor, infection, trauma, vertebral fracture, spinal deformity, advanced spinal stenosis, or another condition other than lumbar disc herniation

Planned spinal fusion or instrumentation

History of a neuromuscular disorder

Severe cognitive impairment, inability to communicate, or inability to complete the QoR-15 questionnaire

Chronic opioid use or a history of opioid dependence

Preoperative lumbar MRI images of insufficient quality for psoas or multifidus muscle measurement

Design

How the study is designed and how its participant groups are organized.

Observational Model: Cohort
Time Perspective: Prospective

Contacts

The people to reach with questions about this study or how to join it.

Doğa Meriç Yükselen, MDContact

d.m.boybeyi@gmail.com+905362963155

Locations

Where the study is run and whether each site is currently recruiting.

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34752, Turkey (Türkiye)

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Fatih Sultan Mehmet Training and Research HospitalOTHER

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Other registered studies that closely resemble this one.

Detailed Description

This is a single-center, prospective observational cohort study involving 100 adults undergoing elective surgery for lumbar disc herniation. No treatment, exposure, or anesthetic technique will be assigned by the study protocol. All participants will receive standard general anesthesia, surgery, and postoperative care according to routine clinical practice and the decisions of the responsible clinical teams. No additional imaging, laboratory testing, medication, or invasive procedure will be performed for research purposes.

Existing preoperative lumbar magnetic resonance imaging scans obtained as part of routine clinical care will be evaluated. Muscle measurements will be performed on axial T2-weighted images at the level of the inferior endplate of the L3 vertebra. The right and left psoas muscles will be manually outlined, and their cross-sectional areas will be summed to calculate the total psoas area. The total psoas area will be divided by height squared to calculate the psoas muscle index in cm²/m².

The right and left multifidus muscles will be evaluated on the same MRI section. Their cross-sectional areas will be measured and summed to calculate the total multifidus muscle area. A height-adjusted multifidus muscle index will also be calculated. MRI measurements will be performed by an investigator who is unaware of the participants' clinical outcomes and QoR-15 scores.

Quality of recovery will be assessed using the validated Turkish version of the 15-item Quality of Recovery questionnaire. The QoR-15 evaluates physical comfort, emotional state, physical independence, psychological support, and pain. Total scores range from 0 to 150, with higher scores indicating better recovery. The questionnaire will be administered before surgery and at 24 hours, 48 hours, and 7 days after surgery.

Postoperative pain at rest will be assessed using the Numeric Rating Scale at 2, 6, 12, and 24 hours after surgery. Other routinely collected data will include opioid and other analgesic consumption during the first 24 hours, requirement for rescue analgesia, postoperative nausea and vomiting, antiemetic requirement, length of stay in the post-anesthesia care unit, time to first mobilization, and total length of hospital stay.

The primary analysis will evaluate the associations of the preoperative psoas muscle index and multifidus muscle measurements with the QoR-15 score 24 hours after surgery. Secondary analyses will evaluate their associations with QoR-15 scores at 48 hours and 7 days, postoperative pain scores, analgesic consumption, postoperative nausea and vomiting, recovery unit stay, time to first mobilization, and hospital length of stay.

Correlations will be assessed using Pearson or Spearman correlation analysis, as appropriate. Multivariable linear regression analysis will be used to identify whether the preoperative muscle measurements are independently associated with the 24-hour QoR-15 score after adjustment for relevant demographic and clinical variables.