Clinical trial NCT05709054: The Effect of Manual Therapy Techniques on the Mobility of the Diaphragm in People With Asthma
Official title: The Effect of Manual Therapy Techniques on the Mobility of the Diaphragm in People With Asthma: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Diaphragm
Breathing retraining
Physiotherapy
Manual therapy
Lead sponsor: University of West Attica
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The mechanical alterations related to the overload of respiratory muscles observed in people with persistent asthma can lead to the development of musculoskeletal dysfunctions. Moreover, the produced lung hyperinflation and high lung volumes in the asthma crisis put the diaphragm at a disadvantage in terms of its length-tension curve and lowered its excursion and capacity to generate force. According to a preliminary study, manual therapy (MT) techniques can be used as adjunctive therapy in asthma treatment. The proposed protocol is the first randomized controlled clinical trial to assess MT's efficacy on the diaphragm's ZOA in conjunction with BRE in individuals with well controlled mild moderate and severe asthma. Many musculoskeletal and respiratory outcomes will be used to investigate the under-study therapies' impact.

Detailed description: The diaphragm produces a craniocaudal movement of its dome during contraction, making it the most crucial breathing muscle due to its unique anatomical structure and contribution to minute ventilation (60%-80%). Patients with (COPD) or asthma often develop diaphragmatic dysfunction (DD). This DD is related to the mechanical linkage between its various parts, placing it at a mechanical disadvantage to the muscle fibers. The capacity of the diaphragm to elevate and extend the lower rib cage at the level of the zone of apposition is impaired by this pathological change. This change increases the work of breathing and weakens the diaphragm. People with moderate or severe asthma may experience pulmonary overstretching, which can lead to functional issues. How physiotherapy may increase the mechanical efficiency of the thoracic cage and the effectiveness of the respiratory muscles during breathing has been the main focus of studies in recent decades. Although the use of specific diaphragm MT techniques does not yet have sufficient research documentation, recently published studies reported that there are indications to support their positive effect on pulmonary rehabilitation. The efficacy of diaphragm MT methods has not been investigated in adults with asthma, although it has been investigated in pediatric asthma. The effect of diaphragms MT techniques in combination with BRE has not been investigated. The present study hypothesizes that the combination of the mentioned physiotherapy techniques will contribute positively to the length-tension relationship and mobility of the diaphragm and chest expansion in patients with asthma. Secondary positive improvements are expected in the domain of functionality, (b) the feeling of dyspnea, (c) disease control and (d) abnormal respiratory pattern. The amplification of the above in people with asthma using respiratory standards and applying diaphragm mobilization techniques will contribute to better disease management.

Eligibility criteria: Inclusion Criteria:

* Aged 18 - 60 years
* Diagnosed with well controlled asthma (mild, moderate-severe) using spirometry
* No acute exacerbation in the last two months

Exclusion Criteria:

* Cardiopulmonary diseases
* Previous cardiothoracic or abdominal surgery
* Patients who have a recent history of the chest wall or abdominal trauma
* Patients with unstable hemodynamic parameters (arterial pressure \>140mmHg systolic and \>90mmHg for diastolic inability to understand the verbal commands necessary for the outcome assessments
* Pregnancy
* Neurological diseases
* Previous or parallel participation in interventional programs.

Primary outcomes:
measure: Diaphragmatic excursion assessment with Ultrasonography
timeFrame: Change from baseline up to 6 weeks and up to 3 months
measure: Chest wall expansion
timeFrame: Change from baseline up to 6 weeks and up to 3 months
Secondary outcomes:
measure: Nijmegen Questionnaire
timeFrame: Change from baseline up to 6 weeks and up to 3 months
measure: Asthma Control Test
timeFrame: Change from baseline up to 6 weeks and up to 3 months
measure: Sf-12v2 questionnaire
timeFrame: Change from baseline up to 6 weeks and up to 3 months
measure: Borg scale
timeFrame: Change from baseline up to 6 weeks and up to 3 months
Other outcomes:
Locations:
city: Ilion
country: Greece
facility: Dimitrios Tsimouris
state: Attiki
Study officials:
References:
citation: Nair A, Alaparthi GK, Krishnan S, Rai S, Anand R, Acharya V, Acharya P. Comparison of Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique on Diaphragmatic Excursion in Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial. Pulm Med. 2019 Jan 3;2019:6364376. doi: 10.1155/2019/6364376. eCollection 2019.
citation: Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.
citation: Greising SM, Ottenheijm CAC, O'Halloran KD, Barreiro E. Diaphragm plasticity in aging and disease: therapies for muscle weakness go from strength to strength. J Appl Physiol (1985). 2018 Aug 1;125(2):243-253. doi: 10.1152/japplphysiol.01059.2017. Epub 2018 Apr 19.
citation: Mergoni M, Rossi A. [Physiopathology of acute respiratory failure in COPD and asthma]. Minerva Anestesiol. 2001 Apr;67(4):198-205. Italian.
citation: Santino TA, Chaves GS, Freitas DA, Fregonezi GA, Mendonca KM. Breathing exercises for adults with asthma. Cochrane Database Syst Rev. 2020 Mar 25;3(3):CD001277. doi: 10.1002/14651858.CD001277.pub4.
citation: Grammatopoulou EP, Skordilis EK, Stavrou N, Myrianthefs P, Karteroliotis K, Baltopoulos G, Koutsouki D. The effect of physiotherapy-based breathing retraining on asthma control. J Asthma. 2011 Aug;48(6):593-601. doi: 10.3109/02770903.2011.587583. Epub 2011 Jun 13.
citation: Elnaggar RK, Shendy MA, Mahmoud MZ. Prospective Effects of Manual Diaphragmatic Release and Thoracic Lymphatic Pumping in Childhood Asthma. Respir Care. 2019 Nov;64(11):1422-1432. doi: 10.4187/respcare.06716. Epub 2019 Jul 23.
citation: Vetrugno L, Guadagnin GM, Barbariol F, Langiano N, Zangrillo A, Bove T. Ultrasound Imaging for Diaphragm Dysfunction: A Narrative Literature Review. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2525-2536. doi: 10.1053/j.jvca.2019.01.003. Epub 2019 Jan 4.
citation: Enrique Leonés-Macías, Irene Torres-Sánchez∗ , Irene Cabrera-Martos, Araceli Ortiz-Rubio, Laura López-López, Marie Carmen Valenza. Effects of manual therapy on the diaphragm in asthmatic patients: A randomized pilot study. International Journal of Osteopathic Medicine; International Journal of Osteopathic Medicine 29 (2018) 26-31DOI: 10.1016/j.ijosm.2018.07.006