Low Back Pain, Ultrasonography
Conditions
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.
Interventions
OTHERBilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training
Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training during 6 weeks
Isolated high-intensity inspiratory muscle training during 8 weeks
Sponsors
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with low back pain during 6 weeks
Exclusion criteria
* Neural disorders * Systemic disorders * Cognitive disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragm muscle thickness | Change from Baseline diaphragm muscle thickness at 8 weeks | Diaphragm muscle thickness in centimeters evaluated by ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity: Visual Analogue Scale | Change from Baseline pain intensity at 8 weeks | Pain intensity scores evaluated by the Visual Analogue Scale from 0 (No pain) to 100 millimeters (Worst pain) |
| Pressure pain threshold | Change from Baseline pressure pain threshold at 8 weeks | Pressure pain threshold in kilograms / squared centimeter evaluated by algometer |
| Disability | Change from Baseline disability at 8 weeks | Disability scores evaluated by the self-reported Roland-Morris Disability Questionnaire from 0 (no disability) to 24 points (Maximum disability) |
| Health-related quality of life scores | Change from Baseline health-related quality of life scores at 8 weeks | 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) |
| Respiratory parameters percentage | Change from Baseline respiratory parameters percentage at 8 weeks | Respiratory parameters percentage evaluated by spirometry |
Countries
Spain
Outcome results
None listed