此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Screening Protocol for Standing-Induced Low Back Pain in Pain Developers

2026年11月11日 更新者：Ala BabajanTabar、University of Tehran

Validation of a Combined Screening Protocol for Predicting Prolonged Standing Induced Low Back Pain in Pain Developers

The goal of this observational study is to learn whether a short screening test can identify healthy young adults who develop low back pain during prolonged standing ("pain developers"). The study includes university students aged 20 to 35 years with no history of clinical low back pain.

The main questions it aims to answer are:

  • How accurately does a combined screening protocol (three simple clinical hip and movement tests plus a 15-minute muscle activity recording of the gluteus medius) identify people who develop low back pain during 2 hours of standing?
  • Can this short protocol be used instead of the standard 2-hour standing test?

Participants will attend two sessions on separate days:

  • Session 1: Participants will complete three clinical tests (self-reported difficulty of a side-lying leg-lifting task, hip rotation range of motion, and a single-leg squat), fill out a pain catastrophizing questionnaire, and stand for 15 minutes while performing a simple manual task, with surface electrodes recording hip muscle activity.
  • Session 2: Participants will stand for 2 hours while performing simple manual tasks and will rate their low back pain every 15 minutes.

Participants who report an increase of at least 10 mm on a 100 mm visual analog scale during the 2-hour standing session will be classified as pain developers. The screening results will be compared with this classification to calculate sensitivity, specificity, and overall accuracy.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

113

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 伊朗
    • Tehran Province
      • Tehran、Tehran Province、伊朗、infosport@ut.ac.ir
        • Faculty of Sport Sciences and Health, University of Tehran

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 35年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Healthy university students aged 20 to 35 years living in University of Tehran dormitories, recruited through electronic and paper announcements in dormitories, the faculty, and dormitory online groups.

描述

Inclusion Criteria:

  • Age 20 to 35 years
  • Body mass index between 20 and 28 kg/m2
  • No lifetime history of clinical low back pain (defined as low back pain that led to consulting a physician or physiotherapist, more than 3 days of absence from work or study, or limitation of daily activities)
  • No previous surgery of the lumbar spine, pelvis, or lower extremities
  • No known neuromuscular, vestibular, or visual disorders
  • Able to stand for 2 hours

Exclusion Criteria:

  • Employment in a job requiring prolonged static standing (more than 1 hour per day) during the past 12 months
  • Any pain in the low back or lower extremities at the start of the standing protocol
  • Inability to complete the questionnaires or perform the movement tests
  • Pregnancy

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
干预/治疗
healthy young adults

University students aged 20-35 years without a history of clinical low back pain, assessed with the combined screening protocol and the 2-hour prolonged standing test.
诊断测试：Combined Screening Protocol

Three clinical tests (self-reported active hip abduction, total hip internal rotation range of motion, single-leg squat) and 15-minute surface EMG of the left gluteus medius during standing.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Diagnostic Accuracy (Sensitivity and Specificity) of the Combined Screening Protocol
大体时间：Index tests at Session 1 (Day 1) compared with the reference standard at Session 2 (within 2-28 days)

Sensitivity, specificity, and overall accuracy (with 95% confidence intervals) of the combined screening protocol (three clinical tests plus gluteus medius EMG gaps) for identifying pain developers, compared with the reference standard (an increase of at least 10 mm on a 100 mm visual analog scale from baseline at any 15-minute timepoint during 2 hours of standing).
Index tests at Session 1 (Day 1) compared with the reference standard at Session 2 (within 2-28 days)

次要结果测量

结果测量
措施说明
大体时间
Pain Developer Status During a 2-Hour Prolonged Standing Test
大体时间：Baseline (minute 0) and every 15 minutes up to 120 minutes during the 2-hour prolonged standing test (Session 2, 2 to 28 days after Session 1)

Low back pain intensity is rated on a 100-mm Visual Analogue Scale (VAS; 0 = no pain, 100 = worst imaginable pain). Participants reporting an increase of ≥10 mm relative to baseline at any measurement point are classified as Pain Developers; all others are classified as Non-Pain Developers. This classification serves as the reference standard.
Baseline (minute 0) and every 15 minutes up to 120 minutes during the 2-hour prolonged standing test (Session 2, 2 to 28 days after Session 1)
Folkins Three-Test Clinical Cluster Scores
大体时间：Session 1 (Day 1)

Three clinical tests: (1) self-rated active hip abduction difficulty (0-5 per side, summed 0-10; positive if ≥4); (2) total bilateral passive hip internal rotation measured with a universal goniometer (degrees; positive if >81.6°); (3) non-dominant single-leg squat, trunk score from video analysis (0, 5, 10, 15; positive if >5).
Session 1 (Day 1)
Number of Gluteus Medius EMG Gaps
大体时间：During a 15-minute standing EMG recording at Session 1 (Day 1)

Number of gaps in glutes medius surface EMG activity during 15 minutes of standing,A gap is defined as a period in which normalized EMG activity falls below 0.5% of maximum voluntary contraction for more than 0.2 seconds. The total number of gaps is reported, compared between pain developers and non-pain developers
During a 15-minute standing EMG recording at Session 1 (Day 1)

其他结果措施

结果测量
措施说明
大体时间
Pain Catastrophizing Scale (PCS) Total Score
大体时间：Session 1 (Day 1)

Correlation between Pain Catastrophizing Scale total score (range 0-52; higher scores indicate greater catastrophizing) and maximum VAS pain in an exploratory subgroup of participants reaching at least 20 mm VAS.
Session 1 (Day 1)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Tehran

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月23日

初级完成 (估计的)

2026年11月13日

研究完成 (估计的)

2026年11月13日

研究注册日期

首次提交

2026年11月1日

首先提交符合 QC 标准的

2026年11月11日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月11日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • UT-LBPD-SCREEN-2026
  • IR.UT.SPORT.REC.1405.047 (其他标识符：Ethics Committee of Sport Sciences, University of Tehran)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

individual participant data will not be shared publicly to protect participant confidentiality, as data sharing was not included in the informed consent. Aggregate results will be reported in publications.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅