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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diaphragm biofeedback reeducation plus inspiratory training | Experimental |
| |
| Isolated high-intensity inspiratory muscle training | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaphragm ultrasonography reeducation plus inspiratory training | Other | Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diaphragm muscle thickness | Diaphragm muscle thickness in centimeters evaluated by ultrasonography | Change from Baseline diaphragm muscle thickness at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain intensity scores evaluated by the Visual Analogue Scale from 0 (No pain) to 100 millimeters (Worst pain) | Change from Baseline pain intensity at 8 weeks |
| Pressure pain threshold |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Complutense de Madrid | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30954705 | Background | 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. | |
| 30545067 |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Isolated inspiratory training | Other | Isolated high-intensity inspiratory muscle training during 8 weeks |
|
Pressure pain threshold in kilograms / squared centimeter evaluated by algometer
| Change from Baseline pressure pain threshold at 8 weeks |
| Disability | Disability scores evaluated by the self-reported Roland-Morris Disability Questionnaire from 0 (no disability) to 24 points (Maximum disability) | Change from Baseline disability at 8 weeks |
| 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) | Change from Baseline health-related quality of life scores at 8 weeks |
| Respiratory parameters percentage | Respiratory parameters percentage evaluated by spirometry | Change from Baseline respiratory parameters percentage at 8 weeks |
| 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. |
| 28272251 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |