Effect of Osteopathic Manual Techniques on the Diaphragm Muscle and Its Repercussions

NCT04399993 | Not Yet Recruiting DMC

• 1 other identifier: OST1- 001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Determining the effects of an intervention plan on the diaphragm related to the center of gravity and range of motion in the lumbar spine (static and dynamic) in healthy individuals is an area that lacks evidence and proper studies. Has such, the investigators consider this a interesting topic to study, therefore it is intended to improve the knowledge on this area.

Conditions

Healthy

Keywords

Osteopathy; Diaphragm; Center of Pressure; Range of Motion; Thoracolumbar

Outcome Measures

Primary Outcomes (1)

• Change from Baseline of Center of gravity immediately after the intervention

  To obtain the center of gravity measurements, it will be used the system Qualisys Track Manager. First, it will be placed in the subject spheric markers on the spinous processes of T12, L3 and S2 and both anterior and posterior superior iliac spines. The cameras will be arranged to cover the area to the test, which it will be performed in a hard surface with the help of reflector-markers that will evaluate the movements. The data will be collected twice, with the eyes open and closed. They'll be standing in the platform for 90 seconds each time and the data will be collected at the 30, 60 and 90 seconds. The software is going to be used to convert the data in coordinates in the x, y and z axis, which it will allow to analyse the tridimensional kinematics of the lumbar spine Through the intrinsical board of Qualysis Track Manager it will be evaluated the relation of the center of pressure with the vertical projection of the center of mass through the distance between both.

  Immediately after the intervention

Secondary Outcomes (1)

• Change from Baseline in Range of Movement of the lumbar spine immediately after the intervention

  Immediately after the intervention

Study Arms (2)

Intervention Protocol in Diaphragm

EXPERIMENTAL

In each volunteer, after a brief questionnaire, it will be measured the center of gravity and the range of movement of the lumbar spine before the technique. Each volunteer will stay in supine position with arms along their body, in which their legs may be either extended or flexed. Next, the researcher will perform the intervention protocol in Diaphragm. Then, all the measurements described before, will be repeated by the assessor right after the technique.

Other: Intervention Protocol in Diaphragm

Sham Technique

SHAM COMPARATOR

In each volunteer, after a brief questionnaire, it will be measured the center of gravity and the range of movement of the lumbar spine before the technique. Each volunteer will stay in supine position with arms along their body, in which their legs may be either extended or flexed. Next, the researcher will perform the Sham technique. Then, all the measurements described before, will be repeated by the assessor right after the technique.

Other: Sham technique

Interventions

Intervention Protocol in Diaphragm OTHER

The protocol consists of three techniques. The two first techniques will be applied for 10 respiratory cycles. Muscle Stretching Technique: the researcher will perform a cephalic traction on the inferior costal border with the ulnar border during the inspiratory phase. Phrenic-center inhibition technique: the researcher, with a hand on the sternum to caudal and other hand on the umbilical region to cranial, will approach his hands on the horizontal plane, when the volunteer exales. Functional diaphragm technique: the researcher will perform a vertical pressure on the diaphragm for 5 minutes and will search for the facilitated parameters and maintain them until the release of all the periarticular elements.

Intervention Protocol in Diaphragm

Sham technique OTHER

In the sham group a manual contact without any therapeutic intention will be performed, in a distant region of the diaphragm (for example on the trapezius muscle). This contact will be maintained during the same amount of time as for the treatment group.

Sham Technique

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages between 18 and 30 years old;
• Both genders;

You may not qualify if:

• Treatments with manual therapy in the last three months or more than three times in the previous year;
• Lumbar spine pathology (infection, spinal fracture or more severe neurological impairment, such as cauda equina syndrome) and respiratory pathologies;
• Psychiatric illness;
• Recent history of trauma;
• History of cancer;
• Systemic inflammatory conditions;
• Recent history of spinal surgery;
• Abdominal pain at the time of the intervention;
• Body mass index (BMI) equal to or greater than 31kg / m2, due to the difficulty in accessing the diaphragm;
• All of those that acquired a higher knowledge within the area of manual therapy, which may compromise its validation.

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Sites (1)

Escola Superior de Saúde do Politécnico do Porto

Porto, 4200-072, Portugal

Location

Related Publications (18)

• Licciardone JC, Kearns CM, Minotti DE. Outcomes of osteopathic manual treatment for chronic low back pain according to baseline pain severity: results from the OSTEOPATHIC Trial. Man Ther. 2013 Dec;18(6):533-40. doi: 10.1016/j.math.2013.05.006. Epub 2013 Jun 10.

  PMID: 23759340 BACKGROUND

• Acute low back problems in adults: assessment and treatment. Agency for Health Care Policy and Research. Clin Pract Guidel Quick Ref Guide Clin. 1994 Dec;(14):iii-iv, 1-25.

  PMID: 7987418 BACKGROUND

• 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.

  PMID: 22411950 BACKGROUND

• Grams ST, von Saltiel R, Mayer AF, Schivinski CI, de S Nobre LF, Nobrega IS, Jacomino ME, Paulin E. Assessment of the reproducibility of the indirect ultrasound method of measuring diaphragm mobility. Clin Physiol Funct Imaging. 2014 Jan;34(1):18-25. doi: 10.1111/cpf.12058. Epub 2013 Jun 4.

  PMID: 23730805 BACKGROUND

• van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A; COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract available.

  PMID: 16550447 BACKGROUND

• 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.

  PMID: 29787734 BACKGROUND

• Savigny P, Watson P, Underwood M; Guideline Development Group. Early management of persistent non-specific low back pain: summary of NICE guidance. BMJ. 2009 Jun 4;338:b1805. doi: 10.1136/bmj.b1805. No abstract available.

  PMID: 19502217 BACKGROUND

• Rubinstein SM, van Middelkoop M, Assendelft WJ, de Boer MR, van Tulder MW. Spinal manipulative therapy for chronic low-back pain: an update of a Cochrane review. Spine (Phila Pa 1976). 2011 Jun;36(13):E825-46. doi: 10.1097/BRS.0b013e3182197fe1.

  PMID: 21593658 BACKGROUND

• Hagg O, Fritzell P, Nordwall A; Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003 Feb;12(1):12-20. doi: 10.1007/s00586-002-0464-0. Epub 2002 Oct 24.

  PMID: 12592542 BACKGROUND

• Bagheri R, Ebrahimi Takamjani I, Dadgoo M, Ahmadi A, Sarrafzadeh J, Pourahmadi MR, Jafarpisheh AS. Gender-Related Differences in Reliability of Thorax, Lumbar, and Pelvis Kinematics During Gait in Patients With Non-specific Chronic Low Back Pain. Ann Rehabil Med. 2018 Apr;42(2):239-249. doi: 10.5535/arm.2018.42.2.239. Epub 2018 Apr 30.

  PMID: 29765877 BACKGROUND

• Shahbazi Moheb Seraj M, Sarrafzadeh J, Maroufi N, Ebrahimi Takamjani I, Ahmadi A, Negahban H. The Ratio of Lumbar to Hip Motion during the Trunk Flexion in Patients with Mechanical Chronic Low Back Pain According to O'Sullivan Classification System: A Cross-sectional Study. Arch Bone Jt Surg. 2018 Nov;6(6):560-569.

  PMID: 30637313 BACKGROUND

• Wu G, Siegler S, Allard P, Kirtley C, Leardini A, Rosenbaum D, Whittle M, D'Lima DD, Cristofolini L, Witte H, Schmid O, Stokes I; Standardization and Terminology Committee of the International Society of Biomechanics. ISB recommendation on definitions of joint coordinate system of various joints for the reporting of human joint motion--part I: ankle, hip, and spine. International Society of Biomechanics. J Biomech. 2002 Apr;35(4):543-8. doi: 10.1016/s0021-9290(01)00222-6.

  PMID: 11934426 BACKGROUND

• Masani K, Vette AH, Kouzaki M, Kanehisa H, Fukunaga T, Popovic MR. Larger center of pressure minus center of gravity in the elderly induces larger body acceleration during quiet standing. Neurosci Lett. 2007 Jul 18;422(3):202-6. doi: 10.1016/j.neulet.2007.06.019. Epub 2007 Jun 17.

  PMID: 17611029 BACKGROUND

• Doyle RJ, Hsiao-Wecksler ET, Ragan BG, Rosengren KS. Generalizability of center of pressure measures of quiet standing. Gait Posture. 2007 Feb;25(2):166-71. doi: 10.1016/j.gaitpost.2006.03.004. Epub 2006 Apr 19.

  PMID: 16624560 BACKGROUND

• Qualisys, A. B., & Gothenburg, S. (2011). Qualisys track manager. New York: User Manual.

  BACKGROUND

• Zemková, E. (2011). Assessment of balance in sport: Science and reality. Serbian Journal of Sports Sciences, (4).

  BACKGROUND

• Donlon, T., Franklin, B., Machamer, C., Mogelnicki, C., Verneus, J., & Taber, C. (2018). FMS Squat Assessment and 2D Video Motion Analysis as Screening Indicators of Low Back Pain: A Cross Sectional Case-Study.

  BACKGROUND

• Souchard, P. E. (1989). O diafragma. Summus editorial.

  BACKGROUND

MeSH Terms

Interventions

Contraceptive Devices, Female

Intervention Hierarchy (Ancestors)

Contraceptive Devices; Equipment and Supplies

Study Officials

• Natália MO Campelo, PhD

  Escola Superior de Saúde do Politécnico do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

+351 938674365; ncampelo.estsp.ipp@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The volunteers will be allocated randomly using a website called radom.org, which ensures that neither neither the volunteer nor the assessor will know the final allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

PT (1)