Low Back Pain Clinical Trial
Official title:
Effectiveness of Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumpo-pelvic Pain
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.
| Status | Not yet recruiting |
| Enrollment | 80 |
| Est. completion date | May 1, 2022 |
| Est. primary completion date | January 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Athletes with non-specific lumbopelvic pain during 6 weeks Exclusion Criteria: - Neural disorders - Systemic disorders - Cognitive disorders |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Universidad Complutense de Madrid | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad de León |
Spain,
Calvo-Lobo C, Almazán-Polo J, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-López P, Rodríguez-Sanz D, López-López 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. — View Citation
Calvo-Lobo C, Diez-Vega I, Martínez-Pascual B, Fernández-Martínez S, de la Cueva-Reguera M, Garrosa-Martín G, Rodríguez-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. — View Citation
Calvo-Lobo C, Painceira-Villar R, López-López D, García-Paz V, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-López P. Tarsal Tunnel Mechanosensitivity Is Increased in Patients with Asthma: A Case-Control Study. J Clin Med. 2018 Dec 12;7(12). pii: E541. doi: 10.3390/jcm7120541. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diaphragm muscle thickness | Diaphragm muscle thickness evaluated in centimeters by ultrasonography | Change from Baseline diaphragm muscle thickness at 8 weeks | |
| Secondary | Pressure pain threshold | Pressure pain threshold evaluated in kilograms / squared centimeter by algometer | Change from Baseline pressure pain threshold at 8 weeks |
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