이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Lower Back Muscle Size and Recovery After Lumbar Disc Herniation Surgery

2026년 8월 13일 업데이트: Doğa Meriç Yükselen, Fatih Sultan Mehmet Training and Research Hospital

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

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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (추정된)

100

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

      • Istanbul, 터키 (Türkiye), 34752
        • Fatih Sultan Mehmet Training and Research Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

The study population will consist of a consecutive sample of adult patients aged 18 to 75 years with ASA physical status I-III who are scheduled for elective surgery for lumbar disc herniation under general anesthesia at Fatih Sultan Mehmet Training and Research Hospital. Eligible participants must have an existing preoperative lumbar MRI suitable for psoas and multifidus muscle measurements and must be able to complete the Turkish version of the QoR-15 questionnaire.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Elective Lumbar Disc Herniation Surgery Cohort
Adults aged 18 to 75 years with ASA physical status I-III who are scheduled for elective surgery for lumbar disc herniation under general anesthesia. Participants will receive routine perioperative care, and no intervention will be assigned by the study protocol. The exposures of interest are the preoperative psoas muscle index and multifidus muscle area and index measured using existing lumbar Magnetic Resonance Imaging (MRI) scans. QoR-15 scores will be recorded before surgery and at 24 hours, 48 hours, and 7 days after surgery. Postoperative pain, analgesic consumption, nausea and vomiting, recovery unit stay, time to first mobilization, and hospital stay will also be recorded.
Preoperative psoas muscle index and multifidus muscle cross-sectional area and index will be measured by manual segmentation of existing axial T2-weighted lumbar MRI images at the L3 inferior endplate level. No additional MRI examination or clinical intervention will be performed. These measurements represent observational exposures whose associations with postoperative QoR-15 scores and other recovery outcomes will be evaluated

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Quality of Recovery-15 (QoR-15) Total Score
기간: Muscle measurements: preoperative; QoR-15 assessment: 24 hours after surgery
The association between preoperative psoas muscle index and multifidus muscle measurements and the total Quality of Recovery-15 (QoR-15) score 24 hours after surgery will be evaluated using correlation and multivariable linear regression analyses.
Muscle measurements: preoperative; QoR-15 assessment: 24 hours after surgery

2차 결과 측정

결과 측정
측정값 설명
기간
QoR-15 Scores at 48 Hours and 7 Days After Surgery
기간: 48 hours and 7 days after surgery
Quality of recovery will be assessed using the total Quality of Recovery-15 (QoR-15) score. The questionnaire contains 15 items and has a total score ranging from 0 to 150, with higher scores indicating better postoperative recovery.
48 hours and 7 days after surgery
Postoperative Numeric Rating Scale Pain Scores at Rest
기간: 2, 6, 12, and 24 hours after surgery
Pain intensity at rest will be assessed using the Numeric Rating Scale. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
2, 6, 12, and 24 hours after surgery
Total Opioid Consumption During the First 24 Hours
기간: Within the first 24 hours after surgery
The cumulative dose of opioid analgesics administered during the first 24 hours after surgery will be obtained from medication records. If more than one opioid is administered, doses will be converted to intravenous morphine milligram equivalents for analysis. Higher values indicate greater opioid consumption.
Within the first 24 hours after surgery
Requirement for Rescue Analgesia
기간: Within the first 24 hours after surgery
The number and percentage of participants who require any additional rescue analgesic medication because of inadequate pain control will be recorded.
Within the first 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting
기간: Within the first 24 hours after surgery
The number and percentage of participants experiencing at least one episode of nausea, vomiting, or both will be recorded using patient reports and routine clinical records.
Within the first 24 hours after surgery
Length of Stay in the Post-Anesthesia Care Unit
기간: From post-anesthesia care unit admission to discharge, typically within 2 hours after surgery
Time from admission to discharge from the post-anesthesia care unit will be recorded in minutes.
From post-anesthesia care unit admission to discharge, typically within 2 hours after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2027년 7월 1일

연구 등록 날짜

최초 제출

2026년 7월 18일

QC 기준을 충족하는 최초 제출

2026년 8월 13일

처음 게시됨 (실제)

2026년 8월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 13일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다