Functional Correlations, Utility Model and Effectiveness of Respiratory Training in Low Back Pain: Health and Gender Education
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ultrasonography
- Sponsor
- Universidad Complutense de Madrid
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Diaphragm muscle thickness
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
César Calvo Lobo
Principal Investigator
Universidad Complutense de Madrid
Eligibility Criteria
Inclusion Criteria
- •Patients with low back pain during 6 weeks
Exclusion Criteria
- •Neural disorders
- •Systemic disorders
- •Cognitive disorders
Outcomes
Primary Outcomes
Diaphragm muscle thickness
Time Frame: Change from Baseline diaphragm muscle thickness at 8 weeks
Diaphragm muscle thickness in centimeters evaluated by ultrasonography
Secondary Outcomes
- Pressure pain threshold(Change from Baseline pressure pain threshold at 8 weeks)
- Health-related quality of life scores(Change from Baseline health-related quality of life scores at 8 weeks)
- Pain intensity: Visual Analogue Scale(Change from Baseline pain intensity at 8 weeks)
- Disability(Change from Baseline disability at 8 weeks)
- Respiratory parameters percentage(Change from Baseline respiratory parameters percentage at 8 weeks)