Objective: To determine the effectiveness of bilateral and simultaneous diaphragm visual biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in patients with low back pain. Methods: A single blinded randomized clinical trial will be carried out. A total sample of 96 patients with low back 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 bilateral and simultaneous 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training during 6 weeks
Isolated high-intensity inspiratory muscle training during 8 weeks
Universidad Complutense de Madrid
Madrid, Spain
Diaphragm muscle thickness
Diaphragm muscle thickness in centimeters evaluated by ultrasonography
Time frame: Change from Baseline diaphragm muscle thickness at 8 weeks
Pain intensity: Visual Analogue Scale
Pain intensity scores evaluated by the Visual Analogue Scale from 0 (No pain) to 100 millimeters (Worst pain)
Time frame: Change from Baseline pain intensity at 8 weeks
Pressure pain threshold
Pressure pain threshold in kilograms / squared centimeter evaluated by algometer
Time frame: 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)
Time frame: 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)
Time frame: Change from Baseline health-related quality of life scores at 8 weeks
Respiratory parameters percentage
Respiratory parameters percentage evaluated by spirometry
Time frame: Change from Baseline respiratory parameters percentage at 8 weeks
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