Ultrasonography Biofeedback for Diaphragm Training in Athletes With Lumbo-pelvic Pain
Primary Purpose
Ultrasonography, Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental
Active comparator
Sponsored by
About this trial
This is an interventional treatment trial for Ultrasonography
Eligibility Criteria
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 evaluated in centimeters by ultrasonography
Secondary Outcome Measures
Pressure pain threshold
Pressure pain threshold evaluated in kilograms / squared centimeter by algometer
Full Information
NCT ID
NCT04097392
First Posted
September 17, 2019
Last Updated
September 18, 2019
Sponsor
Universidad de León
1. Study Identification
Unique Protocol Identification Number
NCT04097392
Brief Title
Ultrasonography Biofeedback for Diaphragm Training in Athletes With Lumbo-pelvic Pain
Official Title
Effectiveness of Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumpo-pelvic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de León
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 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 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 (Anticipated)
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)
Experimental
Intervention Description
Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks
Intervention Type
Other
Intervention Name(s)
Active comparator
Intervention Description
Isolated high-intensity inspiratory muscle training during 8 weeks
Primary Outcome Measure Information:
Title
Diaphragm muscle thickness
Description
Diaphragm muscle thickness evaluated in centimeters by ultrasonography
Time Frame
Change from Baseline diaphragm muscle thickness at 8 weeks
Secondary Outcome Measure Information:
Title
Pressure pain threshold
Description
Pressure pain threshold evaluated in kilograms / squared centimeter by algometer
Time Frame
Change from Baseline pressure pain threshold 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
César Calvo Lobo, PhD
Phone
0034 913 94 15 36
Email
cescalvo@ucm.es
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
César Calvo Lobo, PhD
Phone
0034 913 94 15 36
Email
cescalvo@ucm.es
12. IPD Sharing Statement
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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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
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Ultrasonography Biofeedback for Diaphragm Training in Athletes With Lumbo-pelvic Pain
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