- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07672197
Psoas Major Muscle Intervention on Chronic Lumbar Pain in Cleaning Professionals.
Influence of the Stretching Technique on the Psoas Major Muscle on Chronic Lumbar Pain in Cleaning Professionals: Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cleaning professionals are particularly vulnerable to musculoskeletal pain, predominantly low back pain due to intense occupational hazards like repetitive movements, heavy lifting in awkward postures, and prolonged standing. The psoas major muscle plays a critical role in this clinical context; morphological changes, such as muscle atrophy and fat infiltration, are commonly observed in low back pain patients. Furthermore, a shortened or asymmetrical psoas alters spinal biomechanics-often increasing lumbar lordosis and overloading facet joints-which strongly predisposes individuals to chronic pain and instability. Furthermore, a shortened or asymmetrical psoas alters spinal biomechanics-often increasing lumbar lordosis and overloading facet joints-which strongly predisposes individuals to chronic pain and instability.
This study aims to highlight the biomechanical importance of the iliopsoas muscle and evaluate the therapeutic impact of the stretching technique in reducing symptoms, improving mobility, and preventing functional limitations associated with iliopsoas dysfunction.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Natália MO Campelo, PhD
- Phone Number: +351 222 061 000
- Email: nmc@ess.ipp.pt
Study Locations
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Porto, Portugal, 4200-072
- Escola Superior de Saúde do Porto
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Contact:
- Natália MO Campelo, PhD
- Phone Number: +35122 206 1000
- Email: nmc@ess.ipp.pt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being a cleaning professional for at least 4 years
- Report at least 1 episode of lumbar pain in the last 3 months
Exclusion Criteria:
- Any severe spinal condition (such as spondylolisthesis, spine fracture, etc.)
- Any severe neurological or rheumatological condition
- Pregnancy
- Daily use of pain medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Control group
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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.
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Experimental: Experimental group
Psoas major stretching
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Low Back Pain Intensity at Rest Assessed Using the Numeric Pain Rating Scale (NPRS, 0-10)
Time Frame: Baseline and immediately after completion of the intervention.
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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.
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Baseline and immediately after completion of the intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lumbar Range of Motion Assessed Using the Schober Test
Time Frame: Baseline and immediately after completion of the intervention.
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Lumbar range of motion (ROM) will be assessed using the Schober Test at rest and during anterior lumbar flexion.
The test measures lumbar spine mobility by quantifying the increase in distance between predefined anatomical landmarks during trunk flexion.
Higher values indicate greater lumbar mobility and therefore a better outcome.
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Baseline and immediately after completion of the intervention.
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Hip Flexion Range of Motion Assessed Using a Digital Goniometer
Time Frame: Baseline and immediately after completion of the intervention.
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Hip flexion range of motion (ROM) will be assessed with the participant in the supine position using a digital goniometer.
Measurements will be recorded in degrees (°).
Higher values indicate greater hip flexion mobility and therefore a better outcome.
|
Baseline and immediately after completion of the intervention.
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Collaborators and Investigators
Investigators
- Principal Investigator: Natália MO Campelo, ESS
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OST1-022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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