Respiratory Training in Low Back Pain

NCT04582812 | Completed

• 1 other identifier: LBP-RT
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasonography; Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Diaphragm muscle thickness

  Diaphragm muscle thickness in centimeters evaluated by ultrasonography

  Change from Baseline diaphragm muscle thickness at 8 weeks

Secondary Outcomes (5)

• Pain intensity: Visual Analogue Scale

  Change from Baseline pain intensity at 8 weeks

• Pressure pain threshold

  Change from Baseline pressure pain threshold at 8 weeks

• Disability

  Change from Baseline disability at 8 weeks

• Health-related quality of life scores

  Change from Baseline health-related quality of life scores at 8 weeks

• Respiratory parameters percentage

  Change from Baseline respiratory parameters percentage at 8 weeks

Study Arms (2)

Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training

EXPERIMENTAL

Other: Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training

Isolated high-intensity inspiratory muscle training

ACTIVE COMPARATOR

Other: Isolated inspiratory training

Interventions

Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training OTHER

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

Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training

Isolated inspiratory training OTHER

Isolated high-intensity inspiratory muscle training during 8 weeks

Isolated high-intensity inspiratory muscle training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with low back pain during 6 weeks

You may not qualify if:

• Neural disorders
• Systemic disorders
• Cognitive disorders

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

Related Publications (4)

• 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.

  PMID: 30954705 BACKGROUND

• 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.

  PMID: 30545067 BACKGROUND

• 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.

  PMID: 28272251 BACKGROUND

• 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.

  PMID: 32823967 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 12, 2020
• Study Start: November 30, 2022
• Primary Completion: January 15, 2024
• Study Completion: February 19, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

ES (1)