Ultrasonography Biofeedback for Diaphragm Training in Athletes With Lumbo-pelvic Pain

NCT ID: NCT04097392

Last Updated: 2019-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2022-05-01

Brief Summary

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Objective: To determine the effectiveness of diaphragm biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in athletes with lumbo-pelvic pain. Methods: A single blinded randomized clinical trial will be carried out. A total sample of 80 athletes with lumbo-pelvic 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 diaphragm 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.

Detailed Description

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Conditions

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Ultrasonography Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diaphragm biofeedback reeducation plus inspiratory training

Group Type EXPERIMENTAL

Experimental

Intervention Type OTHER

Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks

Isolated high-intensity inspiratory muscle training

Group Type ACTIVE_COMPARATOR

Active comparator

Intervention Type OTHER

Isolated high-intensity inspiratory muscle training during 8 weeks

Interventions

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Experimental

Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks

Intervention Type OTHER

Active comparator

Isolated high-intensity inspiratory muscle training during 8 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Athletes with non-specific lumbopelvic pain during 6 weeks

Exclusion Criteria

* Neural disorders
* Systemic disorders
* Cognitive disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de León

OTHER

Sponsor Role lead

Responsible Party

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César Calvo Lobo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad Complutense de Madrid

Madrid, , Spain

Site Status

Countries

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Spain

Central Contacts

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César Calvo Lobo, PhD

Role: CONTACT

0034 913 94 15 36

Facility Contacts

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César Calvo Lobo, PhD

Role: primary

0034 913 94 15 36

References

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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.

Reference Type BACKGROUND
PMID: 30954705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30545067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28272251 (View on PubMed)

Other Identifiers

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UCM PR65/19

Identifier Type: -

Identifier Source: org_study_id

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