Low Back PainNCT06994364
Psoas Muscle Release in Non-specific Mechanical Low Back Pain
A study testing Trigger point release and Simulation of the intestinal listening technique. in people with Low Back Pain, run by Escola Superior de Tecnologia da Saúde do Porto.
Trial summary
Nonspecific low back pain affects approximately 80% of the population at some point in their lives. The psoas muscle-positioned between the lumbar and pelvic regions-together with the paravertebral muscles, constitutes the primary muscular group responsible for dynamic stabilization of the spine. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Trigger point release and Simulation of the intestinal listening technique.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 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 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 30 years.
- Presence of low back pain for less than 1 month.
- Presence of a latent trigger point in the psoas muscle.
Who cannot join
- Volunteers with low back pain caused by: Disc herniation, Tumor, Infection, Fracture, Osteoporosis, Structural deformity or Inflammation.
- Individuals with a history of spinal surgery.
- Continuous use of analgesics.
- Participants who had undergone manual therapy in the previous month.
- Pregnant individuals.
- Obese individuals.
Show all 9Show fewer
- Students of Osteopathy (from the 2nd, 3rd, or 4th year) and professionals in the manual therapy field.
- Participants presenting red flags for osteopathic intervention.
- Individuals with cognitive impairments that hindered their ability to understand the study/project.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Psoas Muscle Release in Young Adults With Non-specific Mechanical Low Back Pain: Randomized Controlled Trial
Nonspecific low back pain affects approximately 80% of the population at some point in their lives.
The psoas muscle-positioned between the lumbar and pelvic regions-together with the paravertebral muscles, constitutes the primary muscular group responsible for dynamic stabilization of the spine. Alterations in this muscle may contribute to the onset of low back pain by modifying spinal biomechanics, particularly through increased lumbar lordosis and greater mechanical overload in the lumbar region.
Read more
Latent myofascial trigger points are asymptomatic but can lead to muscle shortening and weakness. They are characterized by local tenderness and may provoke a localized muscular response known as a local twitch response.
The aim of this randomized experimental study was to evaluate the immediate effect of ischemic compression applied to the trigger point of the psoas muscle on pain perception and lumbar range of motion.
Researchers will compare a group with a placebo technique to see if the release of the psoas muscle produces effects in this condition.
The variables analyzed in this study included low back pain, assessed using the Numeric Pain Rating Scale (NPRS); lateral lumbar flexion (right and left), measured using a tape measure (distance from the third finger to the floor); and lumbar flexion range of motion, assessed using the Schober test.
Read the detailed description
The present study will be a randomized, double-blind clinical trial designed to analyze the immediate effect of trigger point release of the psoas muscle on pain and lumbar spine range of motion in young adults with nonspecific mechanical low back pain.
The research will involve a sample composed of individuals aged between 18 and 30 years, who will have experienced low back pain within one month prior to participation and will present a latent trigger point in the psoas muscle.
Participants will be randomly assigned to two groups: the experimental group, which will undergo the ischemic compression technique on the psoas muscle; and the control group, which will receive a simulated technique involving listening to the mobility and motility of the small intestine. Assessments will be conducted before and after the intervention using the Visual Analog Scale (VAS), the Numeric Pain Rating Scale (NPRS), measurement of lumbar lateral flexion with a measuring tape, and the modified Schober test for trunk forward flexion.
This study will aim to address the existing gap in the literature regarding the effectiveness of specific osteopathic techniques applied to the psoas muscle in relieving low back pain and improving mobility and range of motion. The methodological rigor, randomization, and double-blind design will contribute to ensuring the reliability of the collected data and the validity of the results obtained.
- Conditions
- Low Back Pain
- Being tested
- Trigger point release, Simulation of the intestinal listening 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.
Trigger point releaseOther
Ischemic compression technique is based on the application of manual pressure to treat trigger points.
The patient was asked to lie in the supine position on the examination table. The osteopath identified the muscle through deep palpation and movement-based muscle differentiation, then applied 90 seconds of tolerable pressure to the trigger point on both sides.
Simulation of the intestinal listening technique.Other
The patient will be asked to lie in a supine position on the treatment table to simulate the listening technique for assessing the mobility and motility of the small intestine without influencing the final results, with the sensory hand placed below the umbilicus.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | In the control group, the simulation of the technique for listening to the mobility and motility of the small intestine was performed by placing one hand on the abdomen, without pressure. Receives: Other: Simulation of the intestinal listening technique. |
| Experimental group | Experimental | In the experimental group, the trigger point release technique for the psoas muscle was performed. Receives: Other: Trigger point release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain
Low back pain was evaluated using the Numeric Pain Rating Scale (NPRS), a widely used unidimensional instrument for assessing pain intensity in adults. The NPRS is a segmented numeric adaptation of the Visual Analogue Scale (VAS), consisting of a horizontal bar with 11 points, where values range from 0 ("no pain") to 10 ("worst imaginable pain").
Each participant was asked by the researcher to indicate the number, from 0 to 10, that best represented their pain level.
Measured: Immediately after the intervention
Range of motion
Lumbar lateral flexion was assessed using a measuring tape to evaluate the distance from the third fingertip to the floor, while lumbar flexion was measured using the Modified Schober Test.
For lateral flexion, the participant stood upright and performed lateral flexion to the right, with the evaluator measuring the distance from the third finger to the floor. The same procedure was repeated for the left side.
The Modified Schober Test was used to assess lumbar flexion. With the participant standing, the evaluator identified the posterior superior iliac spines (PSIS) and marked a point 15 cm above it. The participant then performed maximal forward trunk flexion with knees extended, and the distance between the two marks was measured.
Lumbar flexion range was the difference between the initial 15 cm and the measurement after flexion.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study startApr 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 (12)Papers the sponsor has linked to this study.
- Other trials for Low Back 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
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994364
- Sponsor's protocol ID
- OST1- 017
- Status last verified
- Sep 2025
- First submitted
- 20 May 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Furtado RN, Ribeiro LH, Abdo Bde A, Descio FJ, Martucci CE Jr, Serruya DC. [Nonspecific low back pain in young adults: associated risk factors]. Rev Bras Reumatol. 2014 Sep-Oct;54(5):371-7. doi: 10.1016/j.rbr.2014.03.018. Epub 2014 Jul 6. Portuguese.
PubMed 25627301Chiarotto A, Maxwell LJ, Ostelo RW, Boers M, Tugwell P, Terwee CB. Measurement Properties of Visual Analogue Scale, Numeric Rating Scale, and Pain Severity Subscale of the Brief Pain Inventory in Patients With Low Back Pain: A Systematic Review. J Pain. 2019 Mar;20(3):245-263. doi: 10.1016/j.jpain.2018.07.009. Epub 2018 Aug 10.
PubMed 30099210Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
PubMed 21982256Seyedhoseinpoor T, Sanjari MA, Taghipour M, Dadgoo M, Mousavi SJ. Spinopelvic malalignment correlates to lumbar instability and lumbar musculature in chronic low back pain-an exploratory study. Sci Rep. 2024 Dec 30;14(1):31974. doi: 10.1038/s41598-024-83570-6.
PubMed 39738674Celik D, Mutlu EK. Clinical implication of latent myofascial trigger point. Curr Pain Headache Rep. 2013 Aug;17(8):353. doi: 10.1007/s11916-013-0353-8.
PubMed 23801006Xu A, Huang Q, Rong J, Wu X, Deng M, Ji L. Effectiveness of ischemic compression on myofascial trigger points in relieving neck pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2023;36(4):783-798. doi: 10.3233/BMR-220045.
PubMed 36872769Siglan U, Colak S. Effects of diaphragmatic and iliopsoas myofascial release in patients with chronic low back pain: A randomized controlled study. J Bodyw Mov Ther. 2023 Jan;33:120-127. doi: 10.1016/j.jbmt.2022.09.029. Epub 2022 Sep 29.
PubMed 36775506Desai R, Rathi M, Palekar TJ. Effects of Movement Retraining and Lumbar Stabilization Exercises in Mechanical Low Back Pain: A Pilot Study. Cureus. 2024 Feb 16;16(2):e54291. doi: 10.7759/cureus.54291. eCollection 2024 Feb.
PubMed 38496129Perret C, Poiraudeau S, Fermanian J, Colau MM, Benhamou MA, Revel M. Validity, reliability, and responsiveness of the fingertip-to-floor test. Arch Phys Med Rehabil. 2001 Nov;82(11):1566-70. doi: 10.1053/apmr.2001.26064.
PubMed 11689977Liu Y, Palmer JL. Iliacus tender points in young adults: a pilot study. J Am Osteopath Assoc. 2012 May;112(5):285-9.
PubMed 22582198Takamoto K, Bito I, Urakawa S, Sakai S, Kigawa M, Ono T, Nishijo H. Effects of compression at myofascial trigger points in patients with acute low back pain: A randomized controlled trial. Eur J Pain. 2015 Sep;19(8):1186-96. doi: 10.1002/ejp.694. Epub 2015 Mar 24.
PubMed 25808188Fernandes WVB, Blanco CR, Politti F, de Cordoba Lanza F, Lucareli PRG, Correa JCF. The effect of a six-week osteopathic visceral manipulation in patients with non-specific chronic low back pain and functional constipation: study protocol for a randomized controlled trial. Trials. 2018 Mar 2;19(1):151. doi: 10.1186/s13063-018-2532-8.
PubMed 29499728
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Psoas Muscle Release in Young Adults With Non-specific Mechanical Low Back Pain: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06994364
- Acronym / sponsor ID
- OST1- 017
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 May 2025 (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.
Nonspecific low back pain affects approximately 80% of the population at some point in their lives.
The psoas muscle-positioned between the lumbar and pelvic regions-together with the paravertebral muscles, constitutes the primary muscular group responsible for dynamic stabilization of the spine. Alterations in this muscle may contribute to the onset of low back pain by modifying spinal biomechanics, particularly through increased lumbar lordosis and greater mechanical overload in the lumbar region.
Latent myofascial trigger points are asymptomatic but can lead to muscle shortening and weakness. They are characterized by local tenderness and may provoke a localized muscular response known as a local twitch response.
The aim of this randomized experimental study was to evaluate the immediate effect of ischemic compression applied to the trigger point of the psoas muscle on pain perception and lumbar range of motion.
Researchers will compare a group with a placebo technique to see if the release of the psoas muscle produces effects in this condition.
The variables analyzed in this study included low back pain, assessed using the Numeric Pain Rating Scale (NPRS); lateral lumbar flexion (right and left), measured using a tape measure (distance from the third finger to the floor); and lumbar flexion range of motion, assessed using the Schober test.
Detailed description
The present study will be a randomized, double-blind clinical trial designed to analyze the immediate effect of trigger point release of the psoas muscle on pain and lumbar spine range of motion in young adults with nonspecific mechanical low back pain.
The research will involve a sample composed of individuals aged between 18 and 30 years, who will have experienced low back pain within one month prior to participation and will present a latent trigger point in the psoas muscle.
Participants will be randomly assigned to two groups: the experimental group, which will undergo the ischemic compression technique on the psoas muscle; and the control group, which will receive a simulated technique involving listening to the mobility and motility of the small intestine. Assessments will be conducted before and after the intervention using the Visual Analog Scale (VAS), the Numeric Pain Rating Scale (NPRS), measurement of lumbar lateral flexion with a measuring tape, and the modified Schober test for trunk forward flexion.
This study will aim to address the existing gap in the literature regarding the effectiveness of specific osteopathic techniques applied to the psoas muscle in relieving low back pain and improving mobility and range of motion. The methodological rigor, randomization, and double-blind design will contribute to ensuring the reliability of the collected data and the validity of the results obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Simulation of the intestinal listening technique.In the control group, the simulation of the technique for listening to the mobility and motility of the small intestine was performed by placing one hand on the abdomen, without pressure. |
| Experimental group | Experimental | Other: Trigger point releaseIn the experimental group, the trigger point release technique for the psoas muscle was performed. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 30 years.
- Presence of low back pain for less than 1 month.
- Presence of a latent trigger point in the psoas muscle.
Key exclusion criteria (9 listed)
- Volunteers with low back pain caused by: Disc herniation, Tumor, Infection, Fracture, Osteoporosis, Structural deformity or Inflammation.
- Individuals with a history of spinal surgery.
- Continuous use of analgesics.
- Participants who had undergone manual therapy in the previous month.
- Pregnant individuals.
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 |
|---|---|---|
| Trigger point releaseIschemic compression technique is based on the application of manual pressure to treat trigger points. The patient was asked to lie in the supine position on the examination table. The osteopath identified the muscle through deep palpation and movement-based muscle differentiation, then applied 90 seconds of tolerable pressure to the trigger point on both sides. | Other | Experimental group |
| Simulation of the intestinal listening technique.The patient will be asked to lie in a supine position on the treatment table to simulate the listening technique for assessing the mobility and motility of the small intestine without influencing the final results, with the sensory hand placed below the umbilicus. | Other | Control group |
Primary outcome
Low back pain
Time frame: Immediately after the intervention
Low back pain was evaluated using the Numeric Pain Rating Scale (NPRS), a widely used unidimensional instrument for assessing pain intensity in adults. The NPRS is a segmented numeric adaptation of the Visual Analogue Scale (VAS), consisting of a horizontal bar with 11 points, where values range from 0 ("no pain") to 10 ("worst imaginable pain"). Each participant was asked by the researcher to indicate the number, from 0 to 10, that best represented their pain level.
Range of motion
Time frame: Immediately after the intervention
Lumbar lateral flexion was assessed using a measuring tape to evaluate the distance from the third fingertip to the floor, while lumbar flexion was measured using the Modified Schober Test. For lateral flexion, the participant stood upright and performed lateral flexion to the right, with the evaluator measuring the distance from the third finger to the floor. The same procedure was repeated for the left side. The Modified Schober Test was used to assess lumbar flexion. With the participant standing, the evaluator identified the posterior superior iliac spines (PSIS) and marked a point 15 cm above it. The participant then performed maximal forward trunk flexion with knees extended, and the distance between the two marks was measured. Lumbar flexion range was the difference between the initial 15 cm and the measurement after flexion.
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 16 Sep 2025.
- Background: PubMed 25627301Furtado RN, Ribeiro LH, Abdo Bde A, Descio FJ, Martucci CE Jr, Serruya DC. [Nonspecific low back pain in young adults: associated risk factors]. Rev Bras Reumatol. 2014 Sep-Oct;54(5):371-7. doi: 10.1016/j.rbr.2014.03.018. Epub 2014 Jul 6. Portuguese.
- Background: PubMed 30099210Chiarotto A, Maxwell LJ, Ostelo RW, Boers M, Tugwell P, Terwee CB. Measurement Properties of Visual Analogue Scale, Numeric Rating Scale, and Pain Severity Subscale of the Brief Pain Inventory in Patients With Low Back Pain: A Systematic Review. J Pain. 2019 Mar;20(3):245-263. doi: 10.1016/j.jpain.2018.07.009. Epub 2018 Aug 10.
- Background: PubMed 21982256Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
- Background: PubMed 39738674Seyedhoseinpoor T, Sanjari MA, Taghipour M, Dadgoo M, Mousavi SJ. Spinopelvic malalignment correlates to lumbar instability and lumbar musculature in chronic low back pain-an exploratory study. Sci Rep. 2024 Dec 30;14(1):31974. doi: 10.1038/s41598-024-83570-6.
- Background: PubMed 23801006Celik D, Mutlu EK. Clinical implication of latent myofascial trigger point. Curr Pain Headache Rep. 2013 Aug;17(8):353. doi: 10.1007/s11916-013-0353-8.
- Background: PubMed 36872769Xu A, Huang Q, Rong J, Wu X, Deng M, Ji L. Effectiveness of ischemic compression on myofascial trigger points in relieving neck pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2023;36(4):783-798. doi: 10.3233/BMR-220045.
- Background: PubMed 36775506Siglan U, Colak S. Effects of diaphragmatic and iliopsoas myofascial release in patients with chronic low back pain: A randomized controlled study. J Bodyw Mov Ther. 2023 Jan;33:120-127. doi: 10.1016/j.jbmt.2022.09.029. Epub 2022 Sep 29.
- Background: PubMed 38496129Desai R, Rathi M, Palekar TJ. Effects of Movement Retraining and Lumbar Stabilization Exercises in Mechanical Low Back Pain: A Pilot Study. Cureus. 2024 Feb 16;16(2):e54291. doi: 10.7759/cureus.54291. eCollection 2024 Feb.
- Background: PubMed 11689977Perret C, Poiraudeau S, Fermanian J, Colau MM, Benhamou MA, Revel M. Validity, reliability, and responsiveness of the fingertip-to-floor test. Arch Phys Med Rehabil. 2001 Nov;82(11):1566-70. doi: 10.1053/apmr.2001.26064.
- Background: PubMed 22582198Liu Y, Palmer JL. Iliacus tender points in young adults: a pilot study. J Am Osteopath Assoc. 2012 May;112(5):285-9.
- Background: PubMed 25808188Takamoto K, Bito I, Urakawa S, Sakai S, Kigawa M, Ono T, Nishijo H. Effects of compression at myofascial trigger points in patients with acute low back pain: A randomized controlled trial. Eur J Pain. 2015 Sep;19(8):1186-96. doi: 10.1002/ejp.694. Epub 2015 Mar 24.
- Background: PubMed 29499728Fernandes WVB, Blanco CR, Politti F, de Cordoba Lanza F, Lucareli PRG, Correa JCF. The effect of a six-week osteopathic visceral manipulation in patients with non-specific chronic low back pain and functional constipation: study protocol for a randomized controlled trial. Trials. 2018 Mar 2;19(1):151. doi: 10.1186/s13063-018-2532-8.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Trigger point release and Simulation of the intestinal listening technique. in people with Low Back Pain, run by Escola Superior de Tecnologia da Saúde do Porto.
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 3 inclusion and 9 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. 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 NCT06994364, which also lists 12 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 16 Sep 2025.