Back to resultsHypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Chronic Nonspecific Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hypo-pressive abdominal exercise intervention
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic non-specific low back pain
Exclusion Criteria:
- Congenital diseases
- Rheumatic or neuro-muscular diseases
- Respiratory conditions
- Surgery
- Pregnancy
Sites / Locations
- Universidad Francisco de Vitoria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hypo-pressive abdominal exercise program
No training program
Arm Description
Outcomes
Primary Outcome Measures
Inspiratory muscle strength
Inspiratory muscle strength will be measured in % by a POWER-breathe device
Secondary Outcome Measures
Diaphragm muscle thickness
Diaphragm muscle thickness will be measured in mm by an ultrasound device
Pressure pain threshold
Pressure pain threshold will be measured in kg/cm2 by an algometer
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.
Full Information
NCT ID
NCT04750187
First Posted
February 7, 2021
Last Updated
May 18, 2021
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04750187
Brief Title
Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Chronic Nonspecific Low Back Pain
Official Title
Effects of Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Patients With Chronic Nonspecific Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypo-pressive abdominal exercise program
Arm Type
Experimental
Arm Title
No training program
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Hypo-pressive abdominal exercise intervention
Intervention Description
An 8-week hypo-pressive abdominal exercise program
Primary Outcome Measure Information:
Title
Inspiratory muscle strength
Description
Inspiratory muscle strength will be measured in % by a POWER-breathe device
Time Frame
Change from baseline inspiratory muscle strength at 8 weeks
Secondary Outcome Measure Information:
Title
Diaphragm muscle thickness
Description
Diaphragm muscle thickness will be measured in mm by an ultrasound device
Time Frame
Change from baseline diaphragm muscle thickness at 8 weeks
Title
Pressure pain threshold
Description
Pressure pain threshold will be measured in kg/cm2 by an algometer
Time Frame
Change from baseline pressure pain threshold at 8 weeks
Title
Disability
Description
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.
Time Frame
Change from baseline disability at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with chronic non-specific low back pain
Exclusion Criteria:
Congenital diseases
Rheumatic or neuro-muscular diseases
Respiratory conditions
Surgery
Pregnancy
Facility Information:
Facility Name
Universidad Francisco de Vitoria
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30954705
Citation
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.
Results Reference
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Learn more about this trial
Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Chronic Nonspecific Low Back Pain
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