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Respiratory Training in Low Back Pain

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ClinicalTrials.gov Identifier: NCT04582812
Recruitment Status : Not yet recruiting
First Posted : October 12, 2020
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
César Calvo Lobo, Universidad Complutense de Madrid

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ultrasonography Low Back Pain Other: Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training Other: Isolated inspiratory training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Correlations, Utility Model and Effectiveness of Respiratory Training in Low Back Pain: Health and Gender Education
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training Other: Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training
Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training during 6 weeks
Active Comparator: Isolated high-intensity inspiratory muscle training Other: Isolated inspiratory training
Isolated high-intensity inspiratory muscle training during 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Diaphragm muscle thickness [ Time Frame: Change from Baseline diaphragm muscle thickness at 8 weeks ]
    Diaphragm muscle thickness in centimeters evaluated by ultrasonography


Secondary Outcome Measures :
  1. Pain intensity: Visual Analogue Scale [ Time Frame: 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)

  2. Pressure pain threshold [ Time Frame: Change from Baseline pressure pain threshold at 8 weeks ]
    Pressure pain threshold in kilograms / squared centimeter evaluated by algometer

  3. Disability [ Time Frame: 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)

  4. Health-related quality of life scores [ Time Frame: 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)

  5. Respiratory parameters percentage [ Time Frame: Change from Baseline respiratory parameters percentage at 8 weeks ]
    Respiratory parameters percentage evaluated by spirometry


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with low back pain during 6 weeks

Exclusion Criteria:

  • Neural disorders
  • Systemic disorders
  • Cognitive disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582812


Contacts
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Contact: César Calvo-Lobo, PhD 0034 913 94 15 36 cescalvo@ucm.es

Locations
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Spain
Universidad Complutense de Madrid
Madrid, Spain, 28040
Contact: César Calvo Lobo, PhD    0034 913 94 15 36    cescalvo@ucm.es   
Principal Investigator: César Calvo Lobo, PhD         
Principal Investigator: David Rodríguez Sanz, PhD         
Sub-Investigator: Ricardo Becerro de Bengoa Vallejo, PhD         
Sub-Investigator: Jose Lopez Chicharro, PhD         
Sponsors and Collaborators
Universidad Complutense de Madrid
More Information
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Publications:

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Responsible Party: César Calvo Lobo, Principal Investigator, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT04582812    
Other Study ID Numbers: LBP-RT
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations