Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Chronic Nonspecific Low Back Pain
Effects of Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Patients With Chronic Nonspecific Low Back Pain
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable low-back-pain
Started Feb 2021
Shorter than P25 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2021
CompletedFirst Posted
Study publicly available on registry
February 11, 2021
CompletedStudy Start
First participant enrolled
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2021
CompletedMay 19, 2021
May 1, 2021
3 months
February 7, 2021
May 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Diaphragm muscle thickness
Change from baseline diaphragm muscle thickness at 8 weeks
Pressure pain threshold
Change from baseline pressure pain threshold at 8 weeks
Disability
Change from baseline disability at 8 weeks
Study Arms (2)
Hypo-pressive abdominal exercise program
EXPERIMENTALNo training program
NO INTERVENTIONInterventions
An 8-week hypo-pressive abdominal exercise program
Eligibility Criteria
You may qualify if:
- Patients with chronic non-specific low back pain
You may not qualify if:
- Congenital diseases
- Rheumatic or neuro-muscular diseases
- Respiratory conditions
- Surgery
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Francisco de Vitoria
Pozuelo de Alarcón, Madrid, 28223, Spain
Related Publications (1)
Calvo-Lobo C, Almazan-Polo J, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-Lopez P, Rodriguez-Sanz D, Lopez-Lopez 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.
PMID: 30954705BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 7, 2021
First Posted
February 11, 2021
Study Start
February 15, 2021
Primary Completion
May 15, 2021
Study Completion
May 18, 2021
Last Updated
May 19, 2021
Record last verified: 2021-05