NCT07672197

Brief Summary

The goal of this randomized controlled trial is to determine the effect of a psoas major muscle intervention on non-specific and chronic lumbar pain in cleaning professionals. It is expected that this intervention will reduce the severity and frequency of symptoms. This study aims to evaluate the effect of psoas major stretching techniques. To collect data, participants will rate their pain intensity on a numeric pain scale at rest and during maximal lumbar flexion. Secondary variables include lumbar flexion range of motion (ROM), assessed by the Schöber test, and hip ROM, which will be measured before and after the intervention using a digital goniometer.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jul 2026Sep 2026

First Submitted

Initial submission to the registry

June 7, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 7, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

manual therapycleaning professionalspsoas majorstretching technique

Outcome Measures

Primary Outcomes (1)

  • Low Back Pain Intensity at Rest Assessed Using the Numeric Pain Rating Scale (NPRS, 0-10)

    Low back pain intensity at rest will be assessed using the Numeric Pain Rating Scale (NPRS), a self-reported scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores indicate greater pain intensity and therefore a worse outcome.

    Baseline and immediately after completion of the intervention.

Secondary Outcomes (2)

  • Lumbar Range of Motion Assessed Using the Schober Test

    Baseline and immediately after completion of the intervention.

  • Hip Flexion Range of Motion Assessed Using a Digital Goniometer

    Baseline and immediately after completion of the intervention.

Study Arms (2)

Experimental group

EXPERIMENTAL

Psoas major stretching

Other: Psoas stretching technique

Control group

PLACEBO COMPARATOR
Other: Placebo

Interventions

The patient is positioned supine at the edge of the table. The investigator places their hands on both of the participant's knees, applying gentle downward pressure on the ipsilateral knee to stretch the psoas major muscle. This stretch is held for 30 seconds and performed bilaterally (once on each side) to the experimental group.

Experimental group
PlaceboOTHER

Patient is positioned supine at the edge of the table. The investigator places one hand on the participant's ipsilateral knee without applying any pressure or force, and the other hand on the contralateral knee for stabilization. This position is maintained for 30 seconds to match the duration of the experimental intervention. The technique was performed bilaterally (once on each side) to the control group.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a cleaning professional for at least 4 years
  • Report at least 1 episode of lumbar pain in the last 3 months

You may not qualify if:

  • Any severe spinal condition (such as spondylolisthesis, spine fracture, etc.)
  • Any severe neurological or rheumatological condition
  • Pregnancy
  • Daily use of pain medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Saúde do Porto

Porto, 4200-072, Portugal

Location

Related Publications (6)

  • Pourahmadi M, Asadi M, Dommerholt J, Yeganeh A. Changes in the macroscopic morphology of hip muscles in low back pain. J Anat. 2020 Jan;236(1):3-20. doi: 10.1111/joa.13086. Epub 2019 Sep 1.

    PMID: 31475359BACKGROUND
  • Abdol Rahman, M. N., Muhamad Jaffar, M. S., Hassan, M. F., Ngali, M. Z., & Pauline, O. Exposure level of ergonomic risk factors in hotel industries. IOP Conference Series: Materials Science and Engineering. 2017. 226, 012018.

    BACKGROUND
  • Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. doi: 10.1136/bmj.332.7555.1430. No abstract available.

    PMID: 16777886BACKGROUND
  • Badarin K, Hemmingsson T, Hillert L, Kjellberg K. Physical workload and increased frequency of musculoskeletal pain: a cohort study of employed men and women with baseline occasional pain. Occup Environ Med. 2021 Jan 17;78(8):558-66. doi: 10.1136/oemed-2020-107094. Online ahead of print.

    PMID: 33455921BACKGROUND
  • Mallio CA, Russo F, Vadala G, Papalia R, Pileri M, Mancuso V, Bernetti C, Volpecina M, Di Gennaro G, Beomonte Zobel B, Denaro V. The importance of psoas muscle on low back pain: a single-center study on lumbar spine MRI. N Am Spine Soc J. 2024 May 1;18:100326. doi: 10.1016/j.xnsj.2024.100326. eCollection 2024 Jun.

    PMID: 38947493BACKGROUND
  • Scherzer T, Rugulies R, Krause N. Work-related pain and injury and barriers to workers' compensation among Las Vegas hotel room cleaners. Am J Public Health. 2005 Mar;95(3):483-8. doi: 10.2105/AJPH.2003.033266.

    PMID: 15727981BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Natália MO Campelo

    ESS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
All evaluations will be conducted by an independent, blinded assessor who is not involved in administering the interventions. First, participants will complete a screening questionnaire to confirm they meet all inclusion and exclusion criteria. Baseline measurements will then be recorded, including pain intensity at rest and during maximal lumbar flexion, as well as lumbar mobility via the Schöber test. Following the initial assessment, the blinded assessor will leave the room, and a separate investigator will administer the assigned intervention. Afterward, the blinded assessor will return to conduct the post-intervention assessment using the same protocols. Participants will be blinded to their group allocation, ensuring a participant- and assessor-blinded study design.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 7, 2026

First Posted

June 26, 2026

Study Start

July 1, 2026

Primary Completion

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations