Low Back PainLBP_DTNCT03600207
The Effect of Diaphragm Muscle Training on Chronic Low Back Pain
A study testing Complex training and Diaphragm training in people with Low Back Pain and Diaphragm, run by Szeged University at 1 site in Hungary.
Trial summary
Brief Summary: Low back pain is very common problem in all the developed countries and affects children to elderly. Based on the etiology the low back pain is divided into two type: nonspecific and specific low back pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Back Pain, Diaphragm
- What is being tested?
- Complex training and Diaphragm training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 4 Sep 2017to Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic low back pain
- Do not take part in other treatment
- Be able to learn the usage of diaphragm trainer
Who cannot join
- Balance problems with neurological cause
- Malignant tumor
- Serious organ disease
- Respiratory disease
- A previous surgical intervention which affected the trunk
- The patient is unable to cooperate
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
SZTE-Egészségtudományi és Szociális Képzési Kar
Szeged, 6726
Regina Finta, +3662546410, fintaregina@etszk.u-szeged.hu
About this study
Brief Summary: Low back pain is very common problem in all the developed countries and affects children to elderly. Based on the etiology the low back pain is divided into two type: nonspecific and specific low back pain. If the pathological reason is known it is defined as specific and if the reason for the pain is unknown it is defined as nonspecific low back pain. The postulated reason for nonspecific low back pain is the segmental instability of the lumbar spine. Diaphragm muscle has a role in maintaining the segmental stability. The aim of this study to reduce the severity of the low back pain with improving the stability of the lumbar spine by using diaphragm training.
Read the detailed description
The study is a randomized controlled trial. The participants are divided randomly into two groups. One of the groups take part in a complex training which contains stretching, strengthening, mobilizing exercises and proprioceptive training and this training is completed by diaphragm strengthening exercises. This group is defined as diaphragm training group. The members of the diaphragm training group use the POWERbreathe Medic Plus device. Opposed to the diaphragm training group the members of the control group take part only in the complex training without strengthening the diaphragm muscle. The pain intensity is assessed by Visual Analogue Scale and the diameter of the stabilizer muscles' belly is measured by B-mode ultrasound examination, using Zonare Z.One Ultrasound System (Mountain View, CA, USA). The thickness of the transversus abdominis muscle, the lumbar multifidus muscle and the diaphragm muscle is assessed in two different positions: during lying and during sitting position with weightlifting. The muscles are measured in two different states: a relaxed and a contracted state. Functional tests and a balance platform (NeuroCom) are used to measure the stability, and the function of the diaphragm is assessed by using a POWERbreathe KH2 device.
- Conditions
- Low Back Pain, Diaphragm
- Being tested
- Complex training, Diaphragm training
- Keywords
- Low Back Pain, Diaphragm
- 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.
Complex trainingOther
The training program contains stretching, mobilizing, strengthening exercises on the trunk and hip muscles and a proprioceptive training.
Diaphragm trainingOther
The training program contains strengthening exercises on the diaphragm muscle.
| Study group | Role | What they receive |
|---|---|---|
| Control group -complex training | Active comparator | complex training Receives: Other: Complex training |
| Experimental group -diaphragm training | Active comparator | diaphragm training Receives: Other: Complex training; Other: Diaphragm training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed by Visual Analogue Scale (followed by its scale information in the Description)
The severity of the pain is measured with Visual Analogue Scale (VAS) before and after the intervention. This is a semi-objective, self-report device that is used extensively to measure such complaints as pain. The sclale is a 10 cm line. The scale is anchored by 'no pain' (0 score) and 'worst imaginable pain' (score of 10). Therefore the higher values represent a worse outcome. When using the Visual Analogue Scale, the participants had to mark on a 10 cm long line the average severity of lumbar pain and we measured the distance of their mark from the zero point in cm-s.
Measured: 8 weeks
Thickness of the stabilizer muscles' belly
The thickness of the stabilizer muscles's belly is measured with an ultrasound examination (Zonare Z.One Ultrasound System). The assessed muscles are transversus abdominis muscle, diaphragm muscle and lumbar multifidus muscle before and after the intervention.
Measured: 8 weeks
Secondary outcomes (4)
Respiratory muscles' function
Respiratory muscles' function is measured with POWERbreathe KH2 device before and after the intervention.
Measured: 8 weeks
Limits of stability in sitting
It is measured by modified Functional and Lateral Reach Test before and after the intervention. Modified means the sitting position.
Measured: 8 weeks
Functional skills
The functional skills are measured by the standard Timed Up and Go Test, Four Square Step Test and Fingertip to Toe Test before and after the intervention.
Measured: 8 week
Balance and stability
The balance and the stability of the participants is measured with a force platform (NeuroCom Basic Balance Master) using CTSIB and Unilateral Stance protocol before and after the intervention.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start4 Sep 2017
- Primary completion30 Sep 2018
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamás Bender, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600207
- Sponsor's protocol ID
- LBP_DT_001
- Acronym
- LBP_DT
- Status last verified
- Dec 2018
- First submitted
- 21 Jun 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diaphragm Muscle Training on Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03600207
- Acronym / sponsor ID
- LBP_DT / LBP_DT_001
- Conditions
- Low Back Pain, Diaphragm
- Keywords
- Low Back Pain, Diaphragm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- Apr 2021 (estimated)
- First posted
- 26 Jul 2018 (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.
Brief Summary: Low back pain is very common problem in all the developed countries and affects children to elderly. Based on the etiology the low back pain is divided into two type: nonspecific and specific low back pain. If the pathological reason is known it is defined as specific and if the reason for the pain is unknown it is defined as nonspecific low back pain. The postulated reason for nonspecific low back pain is the segmental instability of the lumbar spine. Diaphragm muscle has a role in maintaining the segmental stability. The aim of this study to reduce the severity of the low back pain with improving the stability of the lumbar spine by using diaphragm training.
Detailed description
The study is a randomized controlled trial. The participants are divided randomly into two groups. One of the groups take part in a complex training which contains stretching, strengthening, mobilizing exercises and proprioceptive training and this training is completed by diaphragm strengthening exercises. This group is defined as diaphragm training group. The members of the diaphragm training group use the POWERbreathe Medic Plus device. Opposed to the diaphragm training group the members of the control group take part only in the complex training without strengthening the diaphragm muscle. The pain intensity is assessed by Visual Analogue Scale and the diameter of the stabilizer muscles' belly is measured by B-mode ultrasound examination, using Zonare Z.One Ultrasound System (Mountain View, CA, USA). The thickness of the transversus abdominis muscle, the lumbar multifidus muscle and the diaphragm muscle is assessed in two different positions: during lying and during sitting position with weightlifting. The muscles are measured in two different states: a relaxed and a contracted state. Functional tests and a balance platform (NeuroCom) are used to measure the stability, and the function of the diaphragm is assessed by using a POWERbreathe KH2 device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group -complex training | Active comparator | Other: Complex trainingcomplex training |
| Experimental group -diaphragm training | Active comparator | Other: Complex training, Other: Diaphragm trainingdiaphragm training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic low back pain
- Do not take part in other treatment
- Be able to learn the usage of diaphragm trainer
Key exclusion criteria (6 listed)
- Balance problems with neurological cause
- Malignant tumor
- Serious organ disease
- Respiratory disease
- A previous surgical intervention which affected the trunk
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 |
|---|---|---|
| Complex trainingThe training program contains stretching, mobilizing, strengthening exercises on the trunk and hip muscles and a proprioceptive training. | Other | Control group -complex training, Experimental group -diaphragm training |
| Diaphragm trainingThe training program contains strengthening exercises on the diaphragm muscle. | Other | Experimental group -diaphragm training |
Primary outcome
Pain assessed by Visual Analogue Scale (followed by its scale information in the Description)
Time frame: 8 weeks
The severity of the pain is measured with Visual Analogue Scale (VAS) before and after the intervention. This is a semi-objective, self-report device that is used extensively to measure such complaints as pain. The sclale is a 10 cm line. The scale is anchored by 'no pain' (0 score) and 'worst imaginable pain' (score of 10). Therefore the higher values represent a worse outcome. When using the Visual Analogue Scale, the participants had to mark on a 10 cm long line the average severity of lumbar pain and we measured the distance of their mark from the zero point in cm-s.
Thickness of the stabilizer muscles' belly
Time frame: 8 weeks
The thickness of the stabilizer muscles's belly is measured with an ultrasound examination (Zonare Z.One Ultrasound System). The assessed muscles are transversus abdominis muscle, diaphragm muscle and lumbar multifidus muscle before and after the intervention.
4 secondary outcomes
Respiratory muscles' function
Time frame: 8 weeks
Limits of stability in sitting
Time frame: 8 weeks
Functional skills
Time frame: 8 week
Balance and stability
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex training and Diaphragm training in people with Low Back Pain and Diaphragm, run by Szeged University at 1 site in Hungary.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Dec 2018. 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamás Bender, Prof. (+36 14388581, bender.tamas@irgalmas.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessed by Visual Analogue Scale (followed by its scale information in the Description) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2018.