search
Back to results

Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain

Primary Purpose

Ultrasonography, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
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:

  • Athletes with non-specific lumbopelvic 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

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
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
September 18, 2019
Last Updated
June 13, 2022
Sponsor
Universidad Complutense de Madrid
search

1. Study Identification

Unique Protocol Identification Number
NCT04097873
Brief Title
Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain
Official Title
Effectiveness of Ultrasonography Visual Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
April 13, 2022 (Actual)
Study Completion Date
June 13, 2022 (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
Objective: To determine the effectiveness of diaphragm visual biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in athletes with lumbo-pelvic pain. Methods: A single blinded randomized clinical trial will be carried out. A total sample of 80 athletes with lumbo-pelvic 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 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
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
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)
Diaphragm ultrasonography reeducation plus inspiratory training
Intervention Description
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
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: Athletes with non-specific lumbopelvic 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

Learn more about this trial

Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain

We'll reach out to this number within 24 hrs