Lumbar PainNCT07672197
Psoas Major Muscle Intervention on Chronic Lumbar Pain in Cleaning Professionals.
A study testing Psoas stretching technique in people with Lumbar Pain and Non-specific Low Back Pain (NSLBP), run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Pain, Non-specific Low Back Pain (NSLBP)
- What is being tested?
- Psoas stretching technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- Jul 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being a cleaning professional for at least 4 years
- Report at least 1 episode of lumbar pain in the last 3 months
Who cannot join
- Any severe spinal condition (such as spondylolisthesis, spine fracture, etc.)
- Any severe neurological or rheumatological condition
- Pregnancy
- Daily use of pain medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Escola Superior de Saúde do Porto
Porto, 4200-072
Natália MO Campelo, PhD, +35122 206 1000, nmc@ess.ipp.pt
About this study
Official title: Influence of the Stretching Technique on the Psoas Major Muscle on Chronic Lumbar Pain in Cleaning Professionals: Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Lumbar Pain, Non-specific Low Back Pain (NSLBP)
- Being tested
- Psoas stretching technique, Placebo
- Keywords
- manual therapy, cleaning professionals, psoas major, stretching technique
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psoas stretching techniqueOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Psoas major stretching Receives: Other: Psoas stretching technique |
| Control group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after completion of the intervention.
Secondary outcomes (2)
Lumbar Range of Motion Assessed Using the Schober Test
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.
Measured: Baseline and immediately after completion of the intervention.
Hip Flexion Range of Motion Assessed Using a Digital Goniometer
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.
Measured: Baseline and immediately after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lumbar PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália MO Campelo, Principal investigator, ESS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672197
- Sponsor's protocol ID
- OST1-022
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31475359Abdol 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.
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.
PubMed 16777886Badarin 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 Jul 14;78(8):558-566. doi: 10.1136/oemed-2020-107094.
PubMed 33455921Mallio 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.
PubMed 38947493Scherzer 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.
PubMed 15727981
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Stretching Technique on the Psoas Major Muscle on Chronic Lumbar Pain in Cleaning Professionals: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07672197
- Acronym / sponsor ID
- OST1-022
- Conditions
- Lumbar Pain, Non-specific Low Back Pain (NSLBP)
- Keywords
- manual therapy, cleaning professionals, psoas major, stretching technique
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Psoas stretching techniquePsoas major stretching |
| Control group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being a cleaning professional for at least 4 years
- Report at least 1 episode of lumbar pain in the last 3 months
Key exclusion criteria (4 listed)
- Any severe spinal condition (such as spondylolisthesis, spine fracture, etc.)
- Any severe neurological or rheumatological condition
- Pregnancy
- Daily use of pain medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psoas stretching techniqueThe 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. | Other | Experimental group |
| PlaceboPatient 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. | Other | Control group |
Primary outcome
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.
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.
2 secondary outcomes
Lumbar Range of Motion Assessed Using the Schober Test
Time frame: Baseline and immediately after completion of the intervention.
Hip Flexion Range of Motion Assessed Using a Digital Goniometer
Time frame: Baseline and immediately after completion of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 31475359Pourahmadi 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.
- BackgroundAbdol 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: PubMed 16777886Koes 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.
- Background: PubMed 33455921Badarin 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 Jul 14;78(8):558-566. doi: 10.1136/oemed-2020-107094.
- Background: PubMed 38947493Mallio 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.
- Background: PubMed 15727981Scherzer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natália MO Campelo principal investigator
ESS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psoas stretching technique in people with Lumbar Pain and Non-specific Low Back Pain (NSLBP), run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natália MO Campelo, PhD (+351 222 061 000, nmc@ess.ipp.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07672197, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.