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

Not Applicable

Completed

• Conditions: Low Back Pain

• Registration Number: NCT04750187
• Lead Sponsor: Universidad Complutense de Madrid

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-07
• Study First Submitted QC: 2021-02-07
• Study First Posted: 2021-02-11
• Study Start: 2021-02-15
• Status Verified: 2021-05
• Primary Completion: 2021-05-15
• Study Completion: 2021-05-18
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with chronic non-specific low back pain

Exclusion Criteria

• Congenital diseases
• Rheumatic or neuro-muscular diseases
• Respiratory conditions
• Surgery
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Inspiratory muscle strength	Change from baseline inspiratory muscle strength at 8 weeks	Inspiratory muscle strength will be measured in % by a POWER-breathe device

Secondary Outcome Measures

Name	Time	Method
Pressure pain threshold	Change from baseline pressure pain threshold at 8 weeks	Pressure pain threshold will be measured in kg/cm2 by an algometer
Disability	Change from baseline disability at 8 weeks	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.
Diaphragm muscle thickness	Change from baseline diaphragm muscle thickness at 8 weeks	Diaphragm muscle thickness will be measured in mm by an ultrasound device

Trial Locations

Locations (1)

Universidad Francisco de Vitoria; 🇪🇸 Pozuelo De Alarcón, Madrid, Spain