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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097873
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
César Calvo Lobo, Universidad Complutense de Madrid

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ultrasonography Low Back Pain Other: Diaphragm ultrasonography reeducation plus inspiratory training Other: Isolated inspiratory training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Ultrasonography Visual Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain
Actual Study Start Date : July 21, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Diaphragm biofeedback reeducation plus inspiratory training Other: Diaphragm ultrasonography reeducation plus inspiratory training
Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks
Active Comparator: Isolated high-intensity inspiratory muscle training Other: Isolated inspiratory training
Isolated high-intensity inspiratory muscle training during 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Diaphragm muscle thickness [ Time Frame: Change from Baseline diaphragm muscle thickness at 8 weeks ]
    Diaphragm muscle thickness in centimeters evaluated by ultrasonography


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: Change from Baseline pain intensity at 8 weeks ]
    Pain intensity scores evaluated by the Visual Analogue Scale from 0 (No pain) to 100 millimeters (Worst pain)

  2. Pressure pain threshold [ Time Frame: Change from Baseline pressure pain threshold at 8 weeks ]
    Pressure pain threshold in kilograms / squared centimeter evaluated by algometer

  3. Disability [ Time Frame: Change from Baseline disability at 8 weeks ]
    Disability scores evaluated by the self-reported Roland-Morris Disability Questionnaire from 0 (no disability) to 24 points (Maximum disability)

  4. Health-related quality of life scores [ Time Frame: Change from Baseline health-related quality of life scores at 8 weeks ]
    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)

  5. Respiratory parameters percentage [ Time Frame: Change from Baseline respiratory parameters percentage at 8 weeks ]
    Respiratory parameters percentage evaluated by spirometry


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Athletes with non-specific lumbopelvic pain during 6 weeks

Exclusion Criteria:

  • Neural disorders
  • Systemic disorders
  • Cognitive disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097873


Contacts
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Contact: César Calvo-Lobo, PhD 0034 913 94 15 36 cescalvo@ucm.es

Locations
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Spain
Universidad Complutense de Madrid Recruiting
Madrid, Spain, 28040
Contact: César Calvo Lobo, PhD    913941536    cescalvo@ucm.es   
Principal Investigator: César Calvo Lobo, PhD         
Sub-Investigator: José Luis López Chicharro, PhD         
Sponsors and Collaborators
Universidad Complutense de Madrid
More Information
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Publications:

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Responsible Party: César Calvo Lobo, Principal Investigator, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT04097873    
Other Study ID Numbers: Ultrasonography-PR65/19-UCM
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Low Back Pain
Pelvic Pain
Back Pain
 Pain
Neurologic Manifestations
Signs and Symptoms