Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT06375018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-05
First Post:
2024-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the Diaphragm Stretching Technique on Nonspecific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-02', 'studyFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in level of inspiratory capacity immediately after intervention', 'timeFrame': 'Immediately after the intervention', 'description': 'Assessment instruments to assess the degree of disability resulting from low back pain include the respiratory pressure meter.'}, {'measure': 'Change in the level of disability derived from low back pain immediately after the intervention', 'timeFrame': 'Immediately after the intervention', 'description': 'Assessment instruments to evaluate the degree of disability resulting from low back pain include the Visual Analogue Scale. In this scale, a higher score indicates a greater level of pain, correlating with a worse outcome. Conversely, a lower score indicates less pain, corresponding to a better outcome.'}, {'measure': 'Change in the level of functionality of the lumbar spine immediately after the intervention', 'timeFrame': 'Immediately after the intervention', 'description': 'Assessment instruments to assess the degree of disability resulting from low back pain include the Schober test.'}, {'measure': 'Change in the level of functionality of the lumbar spine immediately after the intervention', 'timeFrame': 'Immediately after the intervention', 'description': 'Assessment instruments to assess the degree of disability resulting from low back pain include the measurement of the distance from the hands to the floor after forward flexion of the trunk while standing with knee extension (also known as the Finger Tip Test).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diaphragm', 'Low Back Pain', 'Osteopathy', 'Osteopathic Medicine', 'Stretching Technique', 'Young Adults'], 'conditions': ['Nonspecific Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '16023475', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11744772', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30137842', 'type': 'BACKGROUND', 'citation': '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/'}, {'pmid': '11182126', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33932362', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30568484', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16707389', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12759796', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7952632', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36498470', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20228714', 'type': 'BACKGROUND', 'citation': 'Heuch I, Hagen K, Heuch I, Nygaard O, Zwart JA. 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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.'}, {'pmid': '36732038', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23176991', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9728862', 'type': 'BACKGROUND', 'citation': 'Ludington E, Dexter F. Statistical analysis of total labor pain using the visual analog scale and application to studies of analgesic effectiveness during childbirth. 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Epub 2004 Nov 18.'}, {'pmid': '7785009', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20227641', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12221346', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34768502', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25139243', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23516397', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28532878', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22630613', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11805632', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to analyze the efficacy of diaphragm stretching technique on symptomatology in young adults with nonspecific low back pain.', 'detailedDescription': 'Nonspecific low back pain occurs when there is an imbalance in the lower back between functional load and the ability to perform daily tasks. It is characterized as such when there is no specific and well-determined diagnosis and there are no structural changes.\n\nThe 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.\n\nThere 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.\n\nThis study aims to evaluate the effectiveness of diaphragm stretching techniques on symptoms experienced by young adults with non-specific low back pain.\n\nIn 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nonspecific low back pain;\n* Age between 18 and 30.\n\nExclusion Criteria:\n\n* Serious cardiovascular and cardiorespiratory causes;\n* Spinal pathologies and injuries to the lumbar spine;\n* Cancer patients;\n* Pacemaker or implant carriers;\n* Pregnant women or volunteers suspected of being pregnant.'}, 'identificationModule': {'nctId': 'NCT06375018', 'briefTitle': 'Effect of the Diaphragm Stretching Technique on Nonspecific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Escola Superior de Tecnologia da Saúde do Porto'}, 'officialTitle': 'Effect of the Diaphragm Stretching Technique on Symptomatology in Young Adults With Nonspecific Low Back Pain: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OST1_011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': '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.', 'interventionNames': ['Other: Placebo Technique']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': '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.', 'interventionNames': ['Other: Diaphragm Stretching']}], 'interventions': [{'name': 'Placebo Technique', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Control group']}, {'name': 'Diaphragm Stretching', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4200-072', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Escola Superior de Saúde do Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'centralContacts': [{'name': 'Natália MO Campelo, PhD', 'role': 'CONTACT', 'email': 'nmc@ess.ipp.pt', 'phone': '+35122 206 1000'}], 'overallOfficials': [{'name': 'Natália MO Campelo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Escola Superior de Saúde do Porto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Escola Superior de Tecnologia da Saúde do Porto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Natália Maria Oliveira Campelo', 'investigatorAffiliation': 'Escola Superior de Tecnologia da Saúde do Porto'}}}}