Trials / Completed
CompletedNCT04582812
Respiratory Training in Low Back Pain
Functional Correlations, Utility Model and Effectiveness of Respiratory Training in Low Back Pain: Health and Gender Education
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Universidad Complutense de Madrid · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training | Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training during 6 weeks |
| OTHER | Isolated inspiratory training | Isolated high-intensity inspiratory muscle training during 8 weeks |
Timeline
- Start date
- 2022-11-30
- Primary completion
- 2024-01-15
- Completion
- 2024-02-19
- First posted
- 2020-10-12
- Last updated
- 2024-02-20
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT04582812. Inclusion in this directory is not an endorsement.