Low Back PainNCT04750187
Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Chronic Nonspecific Low Back Pain
A study testing Hypo-pressive abdominal exercise intervention in people with Low Back Pain, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The purpose of this study will be to assess the effects of an 8-week hypo-pressive abdominal exercise program on Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability in patients with non-specific chronic low back pain. A randomized clinical trial will be carried out. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Hypo-pressive abdominal exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2021to 18 May 2021
- 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 chronic non-specific low back pain
Who cannot join
- Congenital diseases
- Rheumatic or neuro-muscular diseases
- Respiratory conditions
- Surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Patients With Chronic Nonspecific Low Back Pain
The purpose of this study will be to assess the effects of an 8-week hypo-pressive abdominal exercise program on Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability in patients with non-specific chronic low back pain. A randomized clinical trial will be carried out. A total sample of 40 patients with non-specific chronic low back pain will be recruited and divided into 2 groups including an experimental group (n=20) which will receive an 8-week hypo-pressive abdominal exercise program and a control group (n=20) which will not receive any training program. Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability will be assessed.
- Conditions
- Low Back Pain
- Being tested
- Hypo-pressive abdominal exercise intervention
- 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.
Hypo-pressive abdominal exercise interventionOther
An 8-week hypo-pressive abdominal exercise program
| Study group | Role | What they receive |
|---|---|---|
| Hypo-pressive abdominal exercise program | Experimental | Not described Receives: Other: Hypo-pressive abdominal exercise intervention |
| No training program | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle strength
Inspiratory muscle strength will be measured in % by a POWER-breathe device
Measured: Change from baseline inspiratory muscle strength at 8 weeks
Secondary outcomes (3)
Diaphragm muscle thickness
Diaphragm muscle thickness will be measured in mm by an ultrasound device
Measured: Change from baseline diaphragm muscle thickness at 8 weeks
Pressure pain threshold
Pressure pain threshold will be measured in kg/cm2 by an algometer
Measured: Change from baseline pressure pain threshold at 8 weeks
Disability
Pain-related disability score will be measured by the Roland-Morris Disability Questionnaire. Total score ranges from 0 to 24. Higher scores represent higher levels of pain-related disability.
Measured: Change from baseline disability 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 posted11 Feb 2021
- Study start15 Feb 2021
- Primary completion15 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- 40 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
- NCT04750187
- Sponsor's protocol ID
- UFV_1/2021
- Status last verified
- May 2021
- First submitted
- 7 Feb 2021
- Last updated
- 19 May 2021
- 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 30954705
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Patients With Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT04750187
- Acronym / sponsor ID
- UFV_1/2021
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 11 Feb 2021 (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.
The purpose of this study will be to assess the effects of an 8-week hypo-pressive abdominal exercise program on Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability in patients with non-specific chronic low back pain. A randomized clinical trial will be carried out. A total sample of 40 patients with non-specific chronic low back pain will be recruited and divided into 2 groups including an experimental group (n=20) which will receive an 8-week hypo-pressive abdominal exercise program and a control group (n=20) which will not receive any training program. Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypo-pressive abdominal exercise program | Experimental | Other: Hypo-pressive abdominal exercise intervention |
| No training program | No intervention | – |
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 chronic non-specific low back pain
Key exclusion criteria (5 listed)
- Congenital diseases
- Rheumatic or neuro-muscular diseases
- Respiratory conditions
- Surgery
- Pregnancy
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 |
|---|---|---|
| Hypo-pressive abdominal exercise interventionAn 8-week hypo-pressive abdominal exercise program | Other | Hypo-pressive abdominal exercise program |
Primary outcome
Inspiratory muscle strength
Time frame: Change from baseline inspiratory muscle strength at 8 weeks
Inspiratory muscle strength will be measured in % by a POWER-breathe device
3 secondary outcomes
Diaphragm muscle thickness
Time frame: Change from baseline diaphragm muscle thickness 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
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 19 May 2021.
- 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.
- 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 Hypo-pressive abdominal exercise intervention in people with 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 5 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 19 May 2021. 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?
Inspiratory muscle strength (time frame: Change from baseline inspiratory muscle strength 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 NCT04750187, which also lists 1 linked publication.
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 19 May 2021.