Respiratory Training in Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Functional Correlations, Utility Model and Effectiveness of Respiratory Training in Low Back Pain: Health and Gender Education

Conditions
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Ultrasonography, Low Back Pain

Intervention / Treatment
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* Other: Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training
* Other: Isolated inspiratory training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with low back pain during 6 weeks Exclusion Criteria: Neural disorders Systemic disorders Cognitive disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training<br> | Other: Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training<br>* Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training during 6 weeks<br>|
| Active Comparator: Isolated high-intensity inspiratory muscle training<br> | Other: Isolated inspiratory training<br>* Isolated high-intensity inspiratory muscle training during 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm muscle thickness | Diaphragm muscle thickness in centimeters evaluated by ultrasonography | Change from Baseline diaphragm muscle thickness at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity: Visual Analogue Scale | Pain intensity scores evaluated by the Visual Analogue Scale from 0 (No pain) to 100 millimeters (Worst pain) | Change from Baseline pain intensity at 8 weeks | 
| Pressure pain threshold | Pressure pain threshold in kilograms / squared centimeter evaluated by algometer | 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) | 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) | Change from Baseline health-related quality of life scores at 8 weeks | 
| Respiratory parameters percentage | Respiratory parameters percentage evaluated by spirometry | Change from Baseline respiratory parameters percentage at 8 weeks |