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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 : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
César Calvo Lobo, Universidad Complutense de Madrid

Tracking Information
First Submitted Date  ICMJE September 18, 2019
First Posted Date  ICMJE September 20, 2019
Last Update Posted Date November 8, 2019
Estimated Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
Diaphragm muscle thickness [ Time Frame: Change from Baseline diaphragm muscle thickness at 8 weeks ]
Diaphragm muscle thickness in centimeters evaluated by ultrasonography
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04097873 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • 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)
  • Pressure pain threshold [ Time Frame: Change from Baseline pressure pain threshold at 8 weeks ]
    Pressure pain threshold in kilograms / squared centimeter evaluated by algometer
  • 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)
  • 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)
  • Respiratory parameters percentage [ Time Frame: Change from Baseline respiratory parameters percentage at 8 weeks ]
    Respiratory parameters percentage evaluated by spirometry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain
Official Title  ICMJE Effectiveness of Ultrasonography Visual Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ultrasonography
  • Low Back Pain
Intervention  ICMJE
  • Other: Diaphragm ultrasonography reeducation plus inspiratory training
    Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks
  • Other: Isolated inspiratory training
    Isolated high-intensity inspiratory muscle training during 8 weeks
Study Arms  ICMJE
  • Experimental: Diaphragm biofeedback reeducation plus inspiratory training
    Intervention: Other: Diaphragm ultrasonography reeducation plus inspiratory training
  • Active Comparator: Isolated high-intensity inspiratory muscle training
    Intervention: Other: Isolated inspiratory training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Athletes with non-specific lumbopelvic pain during 6 weeks

Exclusion Criteria:

  • Neural disorders
  • Systemic disorders
  • Cognitive disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: César Calvo-Lobo, PhD 0034 913 94 15 36 cescalvo@ucm.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04097873
Other Study ID Numbers  ICMJE Ultrasonography-PR65/19-UCM
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party César Calvo Lobo, Universidad Complutense de Madrid
Study Sponsor  ICMJE Universidad Complutense de Madrid
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidad Complutense de Madrid
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP