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

Effectiveness of Ultrasonography Visual Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04097873
Enrollment
80
Registered
2019-09-20
Start date
2020-07-21
Completion date
2022-06-13
Last updated
2022-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Ultrasonography

Brief summary

Objective: To determine the effectiveness of diaphragm visual 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 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.

Interventions

OTHERDiaphragm ultrasonography reeducation plus inspiratory training

Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks

Isolated high-intensity inspiratory muscle training during 8 weeks

Sponsors

Universidad Complutense de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Athletes with non-specific lumbopelvic pain during 6 weeks

Exclusion criteria

* Neural disorders * Systemic disorders * Cognitive disorders

Design outcomes

Primary

MeasureTime frameDescription
Diaphragm muscle thicknessChange from Baseline diaphragm muscle thickness at 8 weeksDiaphragm muscle thickness in centimeters evaluated by ultrasonography

Secondary

MeasureTime frameDescription
Pain intensityChange from Baseline pain intensity at 8 weeksPain intensity scores evaluated by the Visual Analogue Scale from 0 (No pain) to 100 millimeters (Worst pain)
Pressure pain thresholdChange from Baseline pressure pain threshold at 8 weeksPressure pain threshold in kilograms / squared centimeter evaluated by algometer
DisabilityChange from Baseline disability at 8 weeksDisability scores evaluated by the self-reported Roland-Morris Disability Questionnaire from 0 (no disability) to 24 points (Maximum disability)
Health-related quality of life scoresChange from Baseline health-related quality of life scores at 8 weeksQuality 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)
Respiratory parameters percentageChange from Baseline respiratory parameters percentage at 8 weeksRespiratory parameters percentage evaluated by spirometry

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026