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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Tehran Province
-
Tehran, Tehran Province, Iran, infosport@ut.ac.ir
- Faculty of Sport Sciences and Health, University of Tehran
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic Accuracy (Sensitivity and Specificity) of the Combined Screening Protocol
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Developer Status During a 2-Hour Prolonged Standing Test
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Catastrophizing Scale (PCS) Total Score
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UT-LBPD-SCREEN-2026
- IR.UT.SPORT.REC.1405.047 (Annan identifierare: Ethics Committee of Sport Sciences, University of Tehran)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .