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Active, not recruitingNCT07933614Updated Nov 12, 2026

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

An observational study in Low Back Pain and Prolonged Standing, sponsored by University of Tehran. Active, not recruiting at 1 site in Iran. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University of Tehran · Observational

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
113
Ages
20 Years to 35 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Low Back Pain
  • Prolonged Standing

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Keywords

  • Pain Developers
  • Screening
  • Diagnostic Accuracy
  • Gluteus Medius
  • Surface Electromyography
  • Clinical Prediction Rule
  • Pain Catastrophizing
03

In context

Low Back Pain

2,923 studies on the registry are indexed under Low Back Pain; 579 are open to participants now.

This study's enrollment of 113 is above the median of 100 across 482 observational studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

University of Tehran is the lead sponsor of 17 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 20 to 35 years
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
113 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Diagnostic Test: Combined Screening Protocol

Interventions

  • Diagnostic testCombined 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.

06

What researchers measure

Primary outcomes

  1. Diagnostic Accuracy (Sensitivity and Specificity) of the Combined Screening Protocol

    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).

    Time frame: Index tests at Session 1 (Day 1) compared with the reference standard at Session 2 (within 2-28 days)

Secondary outcomes

  1. Pain Developer Status During a 2-Hour Prolonged Standing Test

    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.

    Time frame: 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)

  2. Folkins Three-Test Clinical Cluster Scores

    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).

    Time frame: Session 1 (Day 1)

  3. Number of Gluteus Medius EMG Gaps

    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

    Time frame: During a 15-minute standing EMG recording at Session 1 (Day 1)

Other outcomes

  1. Pain Catastrophizing Scale (PCS) Total Score

    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.

    Time frame: Session 1 (Day 1)

07

Study locations

1 site
  • Faculty of Sport Sciences and Health, University of Tehran
    Tehran, Tehran Province infosport@ut.ac.ir, Iran
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Nov 2026, 3 months after the start.

Of 176 non-industry observational studies under Low Back Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's planned 3 months is below that.

Counting every sponsor, half of 186 studies reached it within 24 months; a quarter within 10 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2026
First posted
Nov 12, 2026
StartActual
Jul 23, 2026
Primary completionEst.
Nov 13, 2026
CompletionEst.
Nov 13, 2026
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07933614
Lead sponsor
University of Tehran
Responsible party
Ala BabajanTabar (MSc Student,Principal Investigator, University of Tehran) — Principal investigator
First posted
Nov 12, 2026
Start date
Jul 23, 2026
Primary completion
Nov 13, 2026 (estimated)
Completion
Nov 13, 2026 (estimated)
Last update
Nov 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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