Respiratory Training in Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582812
• Other study ID #: LBP-RT
• Status: Completed
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: February 19, 2024

Study information

• Verified date: February 2024
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 19, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with low back pain during 6 weeks

Exclusion Criteria:

• Neural disorders

• Systemic disorders

• Cognitive disorders

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Ultrasonography

Intervention

Other:
• Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training
Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training during 6 weeks
• Isolated inspiratory training
Isolated high-intensity inspiratory muscle training during 8 weeks

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Almazan-Polo J, Lopez-Lopez D, Romero-Morales C, Rodriguez-Sanz D, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Bravo-Aguilar M, Calvo-Lobo C. Quantitative Ultrasound Imaging Differences in Multifidus and Thoracolumbar Fasciae between Athletes with and without Chronic Lumbopelvic Pain: A Case-Control Study. J Clin Med. 2020 Aug 14;9(8):2647. doi: 10.3390/jcm9082647. — View Citation

Calvo-Lobo C, Almazan-Polo J, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-Lopez P, Rodriguez-Sanz D, Lopez-Lopez D. Ultrasonography comparison of diaphragm thickness and excursion between athletes with and without lumbopelvic pain. Phys Ther Sport. 2019 May;37:128-137. doi: 10.1016/j.ptsp.2019.03.015. Epub 2019 Mar 28. — View Citation

Calvo-Lobo C, Diez-Vega I, Martinez-Pascual B, Fernandez-Martinez S, de la Cueva-Reguera M, Garrosa-Martin G, Rodriguez-Sanz D. Tensiomyography, sonoelastography, and mechanosensitivity differences between active, latent, and control low back myofascial trigger points: A cross-sectional study. Medicine (Baltimore). 2017 Mar;96(10):e6287. doi: 10.1097/MD.0000000000006287. — View Citation

Calvo-Lobo C, Painceira-Villar R, Lopez-Lopez D, Garcia-Paz V, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-Lopez P. Tarsal Tunnel Mechanosensitivity Is Increased in Patients with Asthma: A Case-Control Study. J Clin Med. 2018 Dec 12;7(12):541. doi: 10.3390/jcm7120541. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm muscle thickness	Diaphragm muscle thickness in centimeters evaluated by ultrasonography	Change from Baseline diaphragm muscle thickness at 8 weeks
Secondary	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
Secondary	Pressure pain threshold	Pressure pain threshold in kilograms / squared centimeter evaluated by algometer	Change from Baseline pressure pain threshold at 8 weeks
Secondary	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
Secondary	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
Secondary	Respiratory parameters percentage	Respiratory parameters percentage evaluated by spirometry	Change from Baseline respiratory parameters percentage at 8 weeks