NCT06994364

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
4mo left

Started Apr 2026

Shorter than P25 for not_applicable low-back-pain

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 Progress24%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

May 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

May 20, 2025

Last Update Submit

September 15, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Immediately after the intervention

Study Arms (2)

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.

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.

Other: Trigger point release

Interventions

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.

Experimental group

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.

Control group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    PMID: 25627301BACKGROUND
  • Chiarotto 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.

    PMID: 30099210BACKGROUND
  • Balague 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.

    PMID: 21982256BACKGROUND
  • Seyedhoseinpoor 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.

    PMID: 39738674BACKGROUND
  • Celik 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.

    PMID: 23801006BACKGROUND
  • Xu 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.

    PMID: 36872769BACKGROUND
  • Siglan 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.

    PMID: 36775506BACKGROUND
  • Desai 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.

    PMID: 38496129BACKGROUND
  • Perret 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.

    PMID: 11689977BACKGROUND
  • Liu Y, Palmer JL. Iliacus tender points in young adults: a pilot study. J Am Osteopath Assoc. 2012 May;112(5):285-9.

    PMID: 22582198BACKGROUND
  • Takamoto 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.

    PMID: 25808188BACKGROUND
  • Fernandes 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.

    PMID: 29499728BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor teacher

Study Record Dates

First Submitted

May 20, 2025

First Posted

May 29, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share