UltrasonographyNCT04582812
Respiratory Training in Low Back Pain
A study testing Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training and Isolated inspiratory training in people with Ultrasonography and Low Back Pain, run by Universidad Complutense de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ultrasonography, Low Back Pain
- What is being tested?
- Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training and Isolated inspiratory training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2022to 19 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with low back pain during 6 weeks
Who cannot join
- Neural disorders
- Systemic disorders
- Cognitive disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Correlations, Utility Model and Effectiveness of Respiratory Training in Low Back Pain: Health and Gender Education
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
- Being tested
- Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training, Isolated inspiratory training
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory trainingOther
Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training during 6 weeks
Isolated inspiratory trainingOther
Isolated high-intensity inspiratory muscle training during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training | Experimental | Not described Receives: Other: Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training |
| Isolated high-intensity inspiratory muscle training | Active comparator | Not described Receives: Other: Isolated inspiratory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm muscle thickness
Diaphragm muscle thickness in centimeters evaluated by ultrasonography
Measured: Change from Baseline diaphragm muscle thickness at 8 weeks
Secondary outcomes (5)
Pain intensity: Visual Analogue Scale
Pain intensity scores evaluated by the Visual Analogue Scale from 0 (No pain) to 100 millimeters (Worst pain)
Measured: Change from Baseline pain intensity at 8 weeks
Pressure pain threshold
Pressure pain threshold in kilograms / squared centimeter evaluated by algometer
Measured: Change from Baseline pressure pain threshold at 8 weeks
Disability
Disability scores evaluated by the self-reported Roland-Morris Disability Questionnaire from 0 (no disability) to 24 points (Maximum disability)
Measured: Change from Baseline disability at 8 weeks
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)
Measured: Change from Baseline health-related quality of life scores at 8 weeks
Respiratory parameters percentage
Respiratory parameters percentage evaluated by spirometry
Measured: Change from Baseline respiratory parameters percentage at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start30 Nov 2022
- Primary completion15 Jan 2024
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Calvo Lobo, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582812
- Sponsor's protocol ID
- LBP-RT
- Status last verified
- Feb 2024
- First submitted
- 3 Oct 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30954705Calvo-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.
PubMed 30545067Calvo-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.
PubMed 28272251Almazan-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.
PubMed 32823967
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Correlations, Utility Model and Effectiveness of Respiratory Training in Low Back Pain: Health and Gender Education
- ClinicalTrials.gov ID
- NCT04582812
- Acronym / sponsor ID
- LBP-RT
- Conditions
- Ultrasonography, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with low back pain during 6 weeks
Key exclusion criteria (3 listed)
- Neural disorders
- Systemic disorders
- Cognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory trainingBilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training during 6 weeks | Other | Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training |
| Isolated inspiratory trainingIsolated high-intensity inspiratory muscle training during 8 weeks | Other | Isolated high-intensity inspiratory muscle training |
Primary outcome
Diaphragm muscle thickness
Time frame: Change from Baseline diaphragm muscle thickness at 8 weeks
Diaphragm muscle thickness in centimeters evaluated by ultrasonography
5 secondary outcomes
Pain intensity: Visual Analogue Scale
Time frame: Change from Baseline pain intensity at 8 weeks
Pressure pain threshold
Time frame: Change from Baseline pressure pain threshold at 8 weeks
Disability
Time frame: Change from Baseline disability at 8 weeks
Health-related quality of life scores
Time frame: Change from Baseline health-related quality of life scores at 8 weeks
Respiratory parameters percentage
Time frame: Change from Baseline respiratory parameters percentage at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 30954705Calvo-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.
- Background: PubMed 30545067Calvo-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.
- Background: PubMed 28272251Calvo-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.
- Background: PubMed 32823967Almazan-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training and Isolated inspiratory training in people with Ultrasonography and Low Back Pain, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm muscle thickness (time frame: Change from Baseline diaphragm muscle thickness at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04582812, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.