Screening Protocol for Standing-Induced Low Back Pain in Pain Developers
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Tehran Province
-
Tehran, Tehran Province, Iran, infosport@ut.ac.ir
- Faculty of Sport Sciences and Health, University of Tehran
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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. |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Diagnostic Accuracy (Sensitivity and Specificity) of the Combined Screening Protocol
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain Developer Status During a 2-Hour Prolonged Standing Test
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain Catastrophizing Scale (PCS) Total Score
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UT-LBPD-SCREEN-2026
- IR.UT.SPORT.REC.1405.047 (Altro identificatore: Ethics Committee of Sport Sciences, University of Tehran)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .