Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain
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ClinicalTrials.gov Identifier: NCT04097873 |
Recruitment Status :
Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : November 8, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ultrasonography Low Back Pain | Other: Diaphragm ultrasonography reeducation plus inspiratory training Other: Isolated inspiratory training | Not Applicable |
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 |
Estimated Study Start Date : | May 1, 2020 |
Estimated Primary Completion Date : | January 1, 2022 |
Estimated Study Completion Date : | May 1, 2022 |

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 |
- Diaphragm muscle thickness [ Time Frame: Change from Baseline diaphragm muscle thickness at 8 weeks ]Diaphragm muscle thickness in centimeters evaluated by ultrasonography
- 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

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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 |
Inclusion Criteria:
- Athletes with non-specific lumbopelvic pain during 6 weeks
Exclusion Criteria:
- Neural disorders
- Systemic disorders
- Cognitive disorders

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
Contact: César Calvo-Lobo, PhD | 0034 913 94 15 36 | cescalvo@ucm.es |
Spain | |
Universidad Complutense de Madrid | Not yet 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 |
Publications:
Responsible Party: | César Calvo Lobo, Principal Investigator, Universidad Complutense de Madrid |
ClinicalTrials.gov Identifier: | NCT04097873 History of Changes |
Other Study ID Numbers: |
Ultrasonography-PR65/19-UCM |
First Posted: | September 20, 2019 Key Record Dates |
Last Update Posted: | November 8, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Back Pain Low Back Pain Pelvic Pain |
Pain Neurologic Manifestations Signs and Symptoms |