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Completed

NCT Number: NCT04582812

Respiratory Training in Low Back Pain

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.

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Key information

Conditions

Ultrasonography Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Complutense de Madrid

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with low back pain during 6 weeks

Exclusion criteria

  • Neural disorders
  • Systemic disorders
  • Cognitive disorders

Treatment and study plan

Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training

Other

Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training during 6 weeks

Isolated inspiratory training

Other

Isolated high-intensity inspiratory muscle training during 8 weeks

Primary outcomes

  1. Diaphragm muscle thickness

    Time frame: Change from Baseline diaphragm muscle thickness at 8 weeks

    Diaphragm muscle thickness in centimeters evaluated by ultrasonography

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2020
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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