Effect of the Diaphragm Stretching Technique on Nonspecific Low Back Pain
NCT ID: NCT06375018
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
45 participants
INTERVENTIONAL
2024-12-31
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Diaphragm Treatment in Reducing Low Back Pain
NCT06069388
Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain
NCT05077566
The Effect of Diaphragm Muscle Training on Chronic Low Back Pain
NCT03600207
Comparison of the Effects of Instrument Assisted Soft Tissue Mobilization Techniques Low Back Pain
NCT05623735
Diaphragm Function in Low Back Pain People
NCT05486858
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The diaphragm and abdominal muscles together create a hydraulic effect in the abdominal cavity, which helps stabilize the spine, providing rigidity to the lumbar spine by increasing intra-abdominal pressure. Diaphragmatic changes in patients diagnosed with low back pain may contribute to the lack of spinal control activity through several mechanisms. Thus, it is concluded that the diaphragm is anatomically related to the lumbar spine, through its muscle fibers.
There are articles that relate the topic of low back pain with Osteopathic Manual Treatment, demonstrating that, despite this lack of scientific evidence, the results obtained at a clinical level are favorable.
This study aims to evaluate the effectiveness of diaphragm stretching techniques on symptoms experienced by young adults with non-specific low back pain.
In this study, the investigators will analyze the effects of the diaphragm stretching technique on the following variables: the sniff nasal inspiratory pressure test (SNIP test) , Visual Analogue Scale (VAS) score, the Schober test and measurement of the distance between the fingers and the ground during anterior flexion of the trunk, without flexion of the lower limbs (also known as the Finger Tip Test).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group
After data collection, each volunteer will undergo a simulated technique within this group. The investigator will mimic the contacts of the phrenic nerve inhibition technique without applying traction or compression to the tissue, merely maintaining the contacts for the same duration as described in the technique performed in the experimental group, along with the same rest period afterward. Subsequently, new data will be collected following the simulated intervention.
Placebo Technique
In the control group, manual contact will be carried out without any therapeutic intention. This contact will be maintained for the same period of time as the experimental group.
Experimental group
After collecting data from each volunteer, a Diaphragm Stretching technique will be administered to individuals in this group. The technique will be executed for a maximum duration of 4 minutes. Following the technique, volunteers will be required to rest for 5 minutes. Subsequently, another round of data collection will be conducted.
Diaphragm Stretching
The participant will be in supine position and the researcher will be at the headrest of the examination table, placing his hands on the lower costal margin. Superior direction traction is performed during inspiration, remaining during expiration. The procedure is repeated for a maximum period of 4 minutes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo Technique
In the control group, manual contact will be carried out without any therapeutic intention. This contact will be maintained for the same period of time as the experimental group.
Diaphragm Stretching
The participant will be in supine position and the researcher will be at the headrest of the examination table, placing his hands on the lower costal margin. Superior direction traction is performed during inspiration, remaining during expiration. The procedure is repeated for a maximum period of 4 minutes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age between 18 and 30.
Exclusion Criteria
* Spinal pathologies and injuries to the lumbar spine;
* Cancer patients;
* Pacemaker or implant carriers;
* Pregnant women or volunteers suspected of being pregnant.
18 Years
30 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Escola Superior de Tecnologia da Saúde do Porto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Natália Maria Oliveira Campelo
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Natália MO Campelo, PhD
Role: PRINCIPAL_INVESTIGATOR
Escola Superior de Saúde do Porto
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Escola Superior de Saúde do Porto
Porto, , Portugal
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Hodges PW, Eriksson AE, Shirley D, Gandevia SC. Intra-abdominal pressure increases stiffness of the lumbar spine. J Biomech. 2005 Sep;38(9):1873-80. doi: 10.1016/j.jbiomech.2004.08.016.
Hodges PW, Heijnen I, Gandevia SC. Postural activity of the diaphragm is reduced in humans when respiratory demand increases. J Physiol. 2001 Dec 15;537(Pt 3):999-1008. doi: 10.1111/j.1469-7793.2001.00999.x.
Bains KNS, Kashyap S, Lappin SL. Anatomy, Thorax: Diaphragm. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK519558/
Hodges PW, Cresswell AG, Daggfeldt K, Thorstensson A. In vivo measurement of the effect of intra-abdominal pressure on the human spine. J Biomech. 2001 Mar;34(3):347-53. doi: 10.1016/s0021-9290(00)00206-2.
Fernandez-Lopez I, Pena-Otero D, Atin-Arratibel MLA, Eguillor-Mutiloa M. Effects of Manual Therapy on the Diaphragm in the Musculoskeletal System: A Systematic Review. Arch Phys Med Rehabil. 2021 Dec;102(12):2402-2415. doi: 10.1016/j.apmr.2021.03.031. Epub 2021 Apr 29.
Finta R, Nagy E, Bender T. The effect of diaphragm training on lumbar stabilizer muscles: a new concept for improving segmental stability in the case of low back pain. J Pain Res. 2018 Nov 28;11:3031-3045. doi: 10.2147/JPR.S181610. eCollection 2018.
Fitting JW. Sniff nasal inspiratory pressure: simple or too simple? Eur Respir J. 2006 May;27(5):881-3. doi: 10.1183/09031936.06.00007906. No abstract available.
Grimstone SK, Hodges PW. Impaired postural compensation for respiration in people with recurrent low back pain. Exp Brain Res. 2003 Jul;151(2):218-24. doi: 10.1007/s00221-003-1433-5. Epub 2003 May 21.
Heritier F, Rahm F, Pasche P, Fitting JW. Sniff nasal inspiratory pressure. A noninvasive assessment of inspiratory muscle strength. Am J Respir Crit Care Med. 1994 Dec;150(6 Pt 1):1678-83. doi: 10.1164/ajrccm.150.6.7952632.
Hershkovich O, Grevitt MP, Lotan R. Schober Test and Its Modifications Revisited-What Are We Actually Measuring? Computerized Tomography-Based Analysis. J Clin Med. 2022 Nov 22;11(23):6895. doi: 10.3390/jcm11236895.
Heuch I, Hagen K, Heuch I, Nygaard O, Zwart JA. The impact of body mass index on the prevalence of low back pain: the HUNT study. Spine (Phila Pa 1976). 2010 Apr 1;35(7):764-8. doi: 10.1097/BRS.0b013e3181ba1531.
Hides J, Gilmore C, Stanton W, Bohlscheid E. Multifidus size and symmetry among chronic LBP and healthy asymptomatic subjects. Man Ther. 2008 Feb;13(1):43-9. doi: 10.1016/j.math.2006.07.017. Epub 2006 Oct 27.
Hodges PW, Gandevia SC. Activation of the human diaphragm during a repetitive postural task. J Physiol. 2000 Jan 1;522 Pt 1(Pt 1):165-75. doi: 10.1111/j.1469-7793.2000.t01-1-00165.xm.
Hodges PW, Gandevia SC. Changes in intra-abdominal pressure during postural and respiratory activation of the human diaphragm. J Appl Physiol (1985). 2000 Sep;89(3):967-76. doi: 10.1152/jappl.2000.89.3.967.
Hodges PW, Cresswell AG, Daggfeldt K, Thorstensson A. Three dimensional preparatory trunk motion precedes asymmetrical upper limb movement. Gait Posture. 2000 Apr;11(2):92-101. doi: 10.1016/s0966-6362(99)00055-7.
Hodges PW, Gurfinkel VS, Brumagne S, Smith TC, Cordo PC. Coexistence of stability and mobility in postural control: evidence from postural compensation for respiration. Exp Brain Res. 2002 Jun;144(3):293-302. doi: 10.1007/s00221-002-1040-x. Epub 2002 Apr 13.
Hodges PW, van Dieen JH, Cholewicki J. Time to Reflect on the Role of Motor Control in Low Back Pain. J Orthop Sports Phys Ther. 2019 Jun;49(6):367-369. doi: 10.2519/jospt.2019.0104.
Iwai K, Nakazato K, Irie K, Fujimoto H, Nakajima H. Trunk muscle strength and disability level of low back pain in collegiate wrestlers. Med Sci Sports Exerc. 2004 Aug;36(8):1296-300. doi: 10.1249/01.mss.0000135791.27929.c1.
Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3.
Kocjan J, Adamek M, Gzik-Zroska B, Czyzewski D, Rydel M. Network of breathing. Multifunctional role of the diaphragm: a review. Adv Respir Med. 2017;85(4):224-232. doi: 10.5603/ARM.2017.0037.
Kolar P, Sulc J, Kyncl M, Sanda J, Neuwirth J, Bokarius AV, Kriz J, Kobesova A. Stabilizing function of the diaphragm: dynamic MRI and synchronized spirometric assessment. J Appl Physiol (1985). 2010 Oct;109(4):1064-71. doi: 10.1152/japplphysiol.01216.2009. Epub 2010 Aug 12.
Krismer M, van Tulder M; Low Back Pain Group of the Bone and Joint Health Strategies for Europe Project. Strategies for prevention and management of musculoskeletal conditions. Low back pain (non-specific). Best Pract Res Clin Rheumatol. 2007 Feb;21(1):77-91. doi: 10.1016/j.berh.2006.08.004.
Langevin HM, Stevens-Tuttle D, Fox JR, Badger GJ, Bouffard NA, Krag MH, Wu J, Henry SM. Ultrasound evidence of altered lumbar connective tissue structure in human subjects with chronic low back pain. BMC Musculoskelet Disord. 2009 Dec 3;10:151. doi: 10.1186/1471-2474-10-151.
Licciardone JC, Moore S, Fix K, Blair LG, Ta K. Osteopathic manipulative treatment of patients with chronic low back pain in the United States: a retrospective cohort study. J Osteopath Med. 2023 Feb 3;123(5):259-267. doi: 10.1515/jom-2022-0212. eCollection 2023 May 1.
Lizier DT, Perez MV, Sakata RK. Exercises for treatment of nonspecific low back pain. Rev Bras Anestesiol. 2012 Nov-Dec;62(6):838-46. doi: 10.1016/S0034-7094(12)70183-6.
Ludington E, Dexter F. Statistical analysis of total labor pain using the visual analog scale and application to studies of analgesic effectiveness during childbirth. Anesth Analg. 1998 Sep;87(3):723-7. doi: 10.1097/00000539-199809000-00045. No abstract available.
Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
Marti-Salvador M, Hidalgo-Moreno L, Domenech-Fernandez J, Lison JF, Arguisuelas MD. Osteopathic Manipulative Treatment Including Specific Diaphragm Techniques Improves Pain and Disability in Chronic Nonspecific Low Back Pain: A Randomized Trial. Arch Phys Med Rehabil. 2018 Sep;99(9):1720-1729. doi: 10.1016/j.apmr.2018.04.022. Epub 2018 May 19.
Mrus JM, Yi MS, Freedberg KA, Wu AW, Zackin R, Gorski H, Tsevat J. Utilities derived from visual analog scale scores in patients with HIV/AIDS. Med Decis Making. 2003 Sep-Oct;23(5):414-21. doi: 10.1177/0272989X03256884.
Muehlbacher M, Nickel MK, Kettler C, Tritt K, Lahmann C, Leiberich PK, Nickel C, Krawczyk J, Mitterlehner FO, Rother WK, Loew TH, Kaplan P. Topiramate in treatment of patients with chronic low back pain: a randomized, double-blind, placebo-controlled study. Clin J Pain. 2006 Jul-Aug;22(6):526-31. doi: 10.1097/.ajp.0000192516.58578.a4.
Myles PS, Troedel S, Boquest M, Reeves M. The pain visual analog scale: is it linear or nonlinear? Anesth Analg. 1999 Dec;89(6):1517-20. doi: 10.1097/00000539-199912000-00038.
Nason LK, Walker CM, McNeeley MF, Burivong W, Fligner CL, Godwin JD. Imaging of the diaphragm: anatomy and function. Radiographics. 2012 Mar-Apr;32(2):E51-70. doi: 10.1148/rg.322115127.
Nava S, Ambrosino N, Crotti P, Fracchia C, Rampulla C. Recruitment of some respiratory muscles during three maximal inspiratory manoeuvres. Thorax. 1993 Jul;48(7):702-7. doi: 10.1136/thx.48.7.702.
Nguyen C, Boutron I, Zegarra-Parodi R, Baron G, Alami S, Sanchez K, Daste C, Boisson M, Fabre L, Krief P, Krief G, Lefevre-Colau MM, Rannou F. Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2021 May 1;181(5):620-630. doi: 10.1001/jamainternmed.2021.0005.
Panjabi MM. The stabilizing system of the spine. Part I. Function, dysfunction, adaptation, and enhancement. J Spinal Disord. 1992 Dec;5(4):383-9; discussion 397. doi: 10.1097/00002517-199212000-00001.
Perez AM, Fernandez-Carnero S, Sicilia-Gomez-de-Parada C, Cuenca-Zaldivar N, Naranjo-Cinto F, Pecos-Martin D, Gallego-Izquierdo T, Nunez-Nagy S. Diaphragmatic Activation Correlated with Lumbar Multifidus Muscles and Thoracolumbar Fascia by B-Mode and M-Mode Ultrasonography in Subjects with and without Non-Specific Low Back Pain: A Pilot Study. Medicina (Kaunas). 2023 Feb 8;59(2):315. doi: 10.3390/medicina59020315.
Romer LM, Polkey MI. Exercise-induced respiratory muscle fatigue: implications for performance. J Appl Physiol (1985). 2008 Mar;104(3):879-88. doi: 10.1152/japplphysiol.01157.2007. Epub 2007 Dec 20.
American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
Stanton TR, Latimer J, Maher CG, Hancock MJ. How do we define the condition 'recurrent low back pain'? A systematic review. Eur Spine J. 2010 Apr;19(4):533-9. doi: 10.1007/s00586-009-1214-3. Epub 2009 Nov 18.
Stokes IA, Gardner-Morse MG, Henry SM. Intra-abdominal pressure and abdominal wall muscular function: Spinal unloading mechanism. Clin Biomech (Bristol). 2010 Nov;25(9):859-66. doi: 10.1016/j.clinbiomech.2010.06.018. Epub 2010 Jul 23.
Stokes M, Rankin G, Newham DJ. Ultrasound imaging of lumbar multifidus muscle: normal reference ranges for measurements and practical guidance on the technique. Man Ther. 2005 May;10(2):116-26. doi: 10.1016/j.math.2004.08.013. Epub 2004 Nov 18.
Uldry C, Fitting JW. Maximal values of sniff nasal inspiratory pressure in healthy subjects. Thorax. 1995 Apr;50(4):371-5. doi: 10.1136/thx.50.4.371.
van Middelkoop M, Rubinstein SM, Verhagen AP, Ostelo RW, Koes BW, van Tulder MW. Exercise therapy for chronic nonspecific low-back pain. Best Pract Res Clin Rheumatol. 2010 Apr;24(2):193-204. doi: 10.1016/j.berh.2010.01.002.
Verbeek JH, van der Weide WE, van Dijk FJ. Early occupational health management of patients with back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1844-51; discussion 1851. doi: 10.1097/00007632-200209010-00006.
Vicente-Campos D, Sanchez-Jorge S, Terron-Manrique P, Guisard M, Collin M, Castano B, Rodriguez-Sanz D, Becerro-de-Bengoa-Vallejo R, Chicharro JL, Calvo-Lobo C. The Main Role of Diaphragm Muscle as a Mechanism of Hypopressive Abdominal Gymnastics to Improve Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial. J Clin Med. 2021 Oct 27;10(21):4983. doi: 10.3390/jcm10214983.
Vleeming A, Schuenke MD, Danneels L, Willard FH. The functional coupling of the deep abdominal and paraspinal muscles: the effects of simulated paraspinal muscle contraction on force transfer to the middle and posterior layer of the thoracolumbar fascia. J Anat. 2014 Oct;225(4):447-62. doi: 10.1111/joa.12227. Epub 2014 Aug 20.
Vostatek P, Novak D, Rychnovsky T, Rychnovska S. Diaphragm postural function analysis using magnetic resonance imaging. PLoS One. 2013;8(3):e56724. doi: 10.1371/journal.pone.0056724. Epub 2013 Mar 14.
Wallden M. The diaphragm - More than an inspired design. J Bodyw Mov Ther. 2017 Apr;21(2):342-349. doi: 10.1016/j.jbmt.2017.03.013. Epub 2017 Apr 6. No abstract available.
Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27.
Winkelstein BA, Weinstein JN, DeLeo JA. The role of mechanical deformation in lumbar radiculopathy: an in vivo model. Spine (Phila Pa 1976). 2002 Jan 1;27(1):27-33. doi: 10.1097/00007632-200201010-00009.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OST1_011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.