NCT04097392

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

September 17, 2019

Last Update Submit

September 18, 2019

Conditions

UltrasonographyLow Back Pain

Outcome Measures

Primary Outcomes (1)

  • Diaphragm muscle thickness

    Diaphragm muscle thickness evaluated in centimeters by ultrasonography

    Change from Baseline diaphragm muscle thickness at 8 weeks

Secondary Outcomes (1)

  • Pressure pain threshold

    Change from Baseline pressure pain threshold at 8 weeks

Study Arms (2)

Diaphragm biofeedback reeducation plus inspiratory training

EXPERIMENTAL
Other: Experimental

Isolated high-intensity inspiratory muscle training

ACTIVE COMPARATOR
Other: Active comparator

Interventions

ExperimentalOTHER

Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks

Diaphragm biofeedback reeducation plus inspiratory training
Active comparatorOTHER

Isolated high-intensity inspiratory muscle training during 8 weeks

Isolated high-intensity inspiratory muscle training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Athletes with non-specific lumbopelvic pain during 6 weeks

You may not qualify if:

  • Neural disorders
  • Systemic disorders
  • Cognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

Related Publications (3)

  • 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: 30954705BACKGROUND

  • 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: 30545067BACKGROUND

  • 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: 28272251BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

César Calvo Lobo, PhD

CONTACT

0034 913 94 15 36cescalvo@ucm.es

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

September 17, 2019

First Posted

September 20, 2019

Study Start

May 1, 2020

Primary Completion

January 1, 2022

Study Completion

May 1, 2022

Last Updated

September 20, 2019

Record last verified: 2019-09

Locations

ES(1)