search
Back to results

Respiratory Training in Low Back Pain

Primary Purpose

Ultrasonography, Low Back Pain

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training
Isolated inspiratory training
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ultrasonography

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with low back pain during 6 weeks

Exclusion Criteria:

  • Neural disorders
  • Systemic disorders
  • Cognitive disorders

Sites / Locations

  • Universidad Complutense de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training

Isolated high-intensity inspiratory muscle training

Arm Description

Outcomes

Primary Outcome Measures

Diaphragm muscle thickness
Diaphragm muscle thickness in centimeters evaluated by ultrasonography

Secondary Outcome Measures

Pain intensity: Visual Analogue Scale
Pain intensity scores evaluated by the Visual Analogue Scale from 0 (No pain) to 100 millimeters (Worst pain)
Pressure pain threshold
Pressure pain threshold in kilograms / squared centimeter evaluated by algometer
Disability
Disability scores evaluated by the self-reported Roland-Morris Disability Questionnaire from 0 (no disability) to 24 points (Maximum disability)
Health-related quality of life scores
Quality of life scores evaluated by the self-reported Medical Outcomes Study Short-Form 36 questionnaire from 0 (lowest health-related quality of life) to 100 (highest health-related quality of life)
Respiratory parameters percentage
Respiratory parameters percentage evaluated by spirometry

Full Information

First Posted
October 3, 2020
Last Updated
March 23, 2023
Sponsor
Universidad Complutense de Madrid
search

1. Study Identification

Unique Protocol Identification Number
NCT04582812
Brief Title
Respiratory Training in Low Back Pain
Official Title
Functional Correlations, Utility Model and Effectiveness of Respiratory Training in Low Back Pain: Health and Gender Education
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

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
Objective: To determine the effectiveness of bilateral and simultaneous diaphragm visual biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in patients with low back pain. Methods: A single blinded randomized clinical trial will be carried out. A total sample of 96 patients with low back pain will be recruited and randomized into 2 groups: one group will be treated by isolated high-intensity inspiratory muscle training during 8 weeks, and another group will be treated with bilateral and simultaneous diaphragm visual biofeedback reeducation by ultrasonography during 6 weeks in conjunction with high-intensity inspiratory muscle training during 8 weeks. Outcome measurements will be diaphragm muscle thickness evaluated by ultrasonography (main outcome measurement), pain intensity, pressure pain threshold, disability, quality of life and respiratory parameters by spirometry, which will be assessed before and after intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultrasonography, Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training
Arm Type
Experimental
Arm Title
Isolated high-intensity inspiratory muscle training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training
Intervention Description
Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training during 6 weeks
Intervention Type
Other
Intervention Name(s)
Isolated inspiratory training
Intervention Description
Isolated high-intensity inspiratory muscle training during 8 weeks
Primary Outcome Measure Information:
Title
Diaphragm muscle thickness
Description
Diaphragm muscle thickness in centimeters evaluated by ultrasonography
Time Frame
Change from Baseline diaphragm muscle thickness at 8 weeks
Secondary Outcome Measure Information:
Title
Pain intensity: Visual Analogue Scale
Description
Pain intensity scores evaluated by the Visual Analogue Scale from 0 (No pain) to 100 millimeters (Worst pain)
Time Frame
Change from Baseline pain intensity at 8 weeks
Title
Pressure pain threshold
Description
Pressure pain threshold in kilograms / squared centimeter evaluated by algometer
Time Frame
Change from Baseline pressure pain threshold at 8 weeks
Title
Disability
Description
Disability scores evaluated by the self-reported Roland-Morris Disability Questionnaire from 0 (no disability) to 24 points (Maximum disability)
Time Frame
Change from Baseline disability at 8 weeks
Title
Health-related quality of life scores
Description
Quality of life scores evaluated by the self-reported Medical Outcomes Study Short-Form 36 questionnaire from 0 (lowest health-related quality of life) to 100 (highest health-related quality of life)
Time Frame
Change from Baseline health-related quality of life scores at 8 weeks
Title
Respiratory parameters percentage
Description
Respiratory parameters percentage evaluated by spirometry
Time Frame
Change from Baseline respiratory parameters percentage 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 low back pain during 6 weeks Exclusion Criteria: Neural disorders Systemic disorders Cognitive disorders
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
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
background
PubMed Identifier
30545067
Citation
Calvo-Lobo C, Painceira-Villar R, Lopez-Lopez D, Garcia-Paz V, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-Lopez P. Tarsal Tunnel Mechanosensitivity Is Increased in Patients with Asthma: A Case-Control Study. J Clin Med. 2018 Dec 12;7(12):541. doi: 10.3390/jcm7120541.
Results Reference
background
PubMed Identifier
28272251
Citation
Calvo-Lobo C, Diez-Vega I, Martinez-Pascual B, Fernandez-Martinez S, de la Cueva-Reguera M, Garrosa-Martin G, Rodriguez-Sanz D. Tensiomyography, sonoelastography, and mechanosensitivity differences between active, latent, and control low back myofascial trigger points: A cross-sectional study. Medicine (Baltimore). 2017 Mar;96(10):e6287. doi: 10.1097/MD.0000000000006287.
Results Reference
background
PubMed Identifier
32823967
Citation
Almazan-Polo J, Lopez-Lopez D, Romero-Morales C, Rodriguez-Sanz D, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Bravo-Aguilar M, Calvo-Lobo C. Quantitative Ultrasound Imaging Differences in Multifidus and Thoracolumbar Fasciae between Athletes with and without Chronic Lumbopelvic Pain: A Case-Control Study. J Clin Med. 2020 Aug 14;9(8):2647. doi: 10.3390/jcm9082647.
Results Reference
background

Learn more about this trial

Respiratory Training in Low Back Pain

We'll reach out to this number within 24 hrs