Clinical trial NCT04097873: Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain
Official title: Effectiveness of Ultrasonography Visual Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasonography
Low Back Pain
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Athletes with non-specific lumbopelvic pain during 6 weeks

Exclusion Criteria:

* Neural disorders
* Systemic disorders
* Cognitive disorders

Primary outcomes:
measure: Diaphragm muscle thickness
timeFrame: Change from Baseline diaphragm muscle thickness at 8 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: Change from Baseline pain intensity at 8 weeks
measure: Pressure pain threshold
timeFrame: Change from Baseline pressure pain threshold at 8 weeks
measure: Disability
timeFrame: Change from Baseline disability at 8 weeks
measure: Health-related quality of life scores
timeFrame: Change from Baseline health-related quality of life scores at 8 weeks
measure: Respiratory parameters percentage
timeFrame: Change from Baseline respiratory parameters percentage at 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.