Respiratory Training in Low Back Pain

February 19, 2024 updated by: César Calvo Lobo, Universidad Complutense de Madrid

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Universidad Complutense de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with low back pain during 6 weeks

Exclusion Criteria:

  • Neural disorders
  • Systemic disorders
  • Cognitive disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Isolated high-intensity inspiratory muscle training
Other: Isolated inspiratory training
Isolated high-intensity inspiratory muscle training during 8 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragm muscle thickness
Time Frame: Change from Baseline diaphragm muscle thickness at 8 weeks
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
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)
Change from Baseline pain intensity at 8 weeks
Pressure pain threshold
Time Frame: Change from Baseline pressure pain threshold at 8 weeks
Pressure pain threshold in kilograms / squared centimeter evaluated by algometer
Change from Baseline pressure pain threshold at 8 weeks
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)
Change from Baseline disability at 8 weeks
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)
Change from Baseline health-related quality of life scores at 8 weeks
Respiratory parameters percentage
Time Frame: Change from Baseline respiratory parameters percentage at 8 weeks
Respiratory parameters percentage evaluated by spirometry
Change from Baseline respiratory parameters percentage at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2022

Primary Completion (Actual)

January 15, 2024

Study Completion (Actual)

February 19, 2024

Study Registration Dates

First Submitted

October 3, 2020

First Submitted That Met QC Criteria

October 8, 2020

First Posted (Actual)

October 12, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBP-RT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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