Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Chronic Nonspecific Low Back Pain

Low Back Pain Clinical Trial

Official title:

Effects of Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Patients With Chronic Nonspecific Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750187
• Other study ID #: UFV_1/2021
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: May 18, 2021

Study information

• Verified date: May 2021
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study will be to assess the effects of an 8-week hypo-pressive abdominal exercise program on Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability in patients with non-specific chronic low back pain. A randomized clinical trial will be carried out. A total sample of 40 patients with non-specific chronic low back pain will be recruited and divided into 2 groups including an experimental group (n=20) which will receive an 8-week hypo-pressive abdominal exercise program and a control group (n=20) which will not receive any training program. Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 18, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with chronic non-specific low back pain

Exclusion Criteria:

• Congenital diseases

• Rheumatic or neuro-muscular diseases

• Respiratory conditions

• Surgery

• Pregnancy

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Hypo-pressive abdominal exercise intervention
An 8-week hypo-pressive abdominal exercise program

Locations

Country	Name	City	State
Spain	Universidad Francisco de Vitoria	Pozuelo De Alarcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Calvo-Lobo C, Almazán-Polo J, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-López P, Rodríguez-Sanz D, López-López D. Ultrasonography comparison of diaphragm thickness and excursion between athletes with and without lumbopelvic pain. Phys Ther Sport. 2019 May;37:128-137. doi: 10.1016/j.ptsp.2019.03.015. Epub 2019 Mar 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory muscle strength	Inspiratory muscle strength will be measured in % by a POWER-breathe device	Change from baseline inspiratory muscle strength at 8 weeks
Secondary	Diaphragm muscle thickness	Diaphragm muscle thickness will be measured in mm by an ultrasound device	Change from baseline diaphragm muscle thickness at 8 weeks
Secondary	Pressure pain threshold	Pressure pain threshold will be measured in kg/cm2 by an algometer	Change from baseline pressure pain threshold at 8 weeks
Secondary	Disability	Pain-related disability score will be measured by the Roland-Morris Disability Questionnaire. Total score ranges from 0 to 24. Higher scores represent higher levels of pain-related disability.	Change from baseline disability at 8 weeks