Low Back Pain, MechanicalNCT04554563
The Effect of Core Stability Training on Deep Stabilizing Muscles.
A study testing Core stability training in people with Low Back Pain, Mechanical and Low Back Pain, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial summary
Non-specific low back pain is the most cause of adult disability throughout life. Its prevalence widens in young adults. Background of this pathology can be multifactorial. One of the most common is poor core stability and overloading of the local tissues as a result. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Low Back Pain, Mechanical, Low Back Pain, Low Back Pain, Postural
- What is being tested?
- Core stability training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 12 Sep 2020to 8 Jan 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- low back pain
- age from 18 to 30 years old
- written consent of the participants
Who cannot join
- injuries of the spine
- fractures of the spine
- surgery interventions in the spine region prior to the study
- psychiatric disorders
- neurologic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Core Stability Training on the Transverse Abdomen and Multifidus Muscles Morphology in Young Non-specific Low Back Pain Individuals.
Non-specific low back pain is the most cause of adult disability throughout life. Its prevalence widens in young adults. Background of this pathology can be multifactorial. One of the most common is poor core stability and overloading of the local tissues as a result.
Among treatment methods stabilizing training is commonly used with good effects. This form of therapy affects the transverse abdomen and multifidus muscles. To assess these structures several methods can be applied, e.g. sonofeedback.
Our hypothesis claims that the core muscles morphology will change over the training process duration, in result, the analgesic effect will be achieved.
Read the detailed description
Non-specific low back pain is the most cause of adult disability throughout life. Its prevalence widens in young adults. Background of this pathology can be multifactorial. One of the most common is poor core stability and overloading of the local tissues as a result.
Among treatment methods stabilizing training is commonly used with good effects. This form of therapy affects the transverse abdomen (TrA) and multifidus (MF) muscles. To assess these structures several methods can be applied, e.g. sonofeedback.
All participants will be randomly divided into two groups:
- Training group (TG)
- Control group (CG)
Outcome measure:
Pre- and post-therapy outcome measure will be done. It will include:
- ultrasound (sonofeedback) of the TrA and MF
- Oswestry Disability Index questionnaire (ODI)
- subjective pain scale - Numeric Rating Scale (NRS)
Intervention:
Core stability training including 4 exercise positions, each of 15 repetitions, 4 sets. Once a day, 5 times a week, 20 sessions in total (4 weeks).
Our hypothesis claims that the core muscles morphology will change over the training process duration, in result, the analgesic effect will be achieved.
- Being tested
- Core stability training
- Keywords
- low back pain, ultrasound, sonofeedback, core stability, lumbar spine, transverse abdomen, multifidus
- 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.
Core stability trainingOther
20 sessions of specific core stability exercise with no external loading.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | 4-week core stability training Receives: Other: Core stability training |
| Control group | No intervention | Standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound
Non-invasive measure of the TrA and MF muscles
Measured: 5 minutes
Pain level
Numeric Rating Scale. Picking the number on a scale from 0 to 10.
Measured: 1 minute
Questionnaire
Oswestry Disability Index questionnaire - subjective disability measure throughout daily living activities.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start12 Sep 2020
- Primary completion20 Dec 2020
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies 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
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Kuligowski, Wroclaw University of Health and Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554563
- Sponsor's protocol ID
- USG TrA MF
- Status last verified
- Jan 2021
- First submitted
- 12 Sep 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Masse-Alarie H, Beaulieu LD, Preuss R, Schneider C. Repetitive peripheral magnetic neurostimulation of multifidus muscles combined with motor training influences spine motor control and chronic low back pain. Clin Neurophysiol. 2017 Mar;128(3):442-453. doi: 10.1016/j.clinph.2016.12.020. Epub 2016 Dec 28.
PubMed 28160750Hides JA, Walsh JC, Smith MMF, Mendis MD. Self-Managed Exercises, Fitness and Strength Training, and Multifidus Muscle Size in Elite Footballers. J Athl Train. 2017 Jul;52(7):649-655. doi: 10.4085/1062-6050-52.3.13. Epub 2017 May 1.
PubMed 28459281Finta R, Nagy E, Bender T. The effect of diaphragm training on lumbar stabilizer muscles: a new concept for improving segmental stability in the case of low back pain. J Pain Res. 2018 Nov 28;11:3031-3045. doi: 10.2147/JPR.S181610. eCollection 2018.
PubMed 30568484
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Core Stability Training on the Transverse Abdomen and Multifidus Muscles Morphology in Young Non-specific Low Back Pain Individuals.
- ClinicalTrials.gov ID
- NCT04554563
- Acronym / sponsor ID
- USG TrA MF
- Keywords
- low back pain, ultrasound, sonofeedback, core stability, lumbar spine, transverse abdomen, multifidus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 18 Sep 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.
Non-specific low back pain is the most cause of adult disability throughout life. Its prevalence widens in young adults. Background of this pathology can be multifactorial. One of the most common is poor core stability and overloading of the local tissues as a result.
Among treatment methods stabilizing training is commonly used with good effects. This form of therapy affects the transverse abdomen and multifidus muscles. To assess these structures several methods can be applied, e.g. sonofeedback.
Our hypothesis claims that the core muscles morphology will change over the training process duration, in result, the analgesic effect will be achieved.
Detailed description
Non-specific low back pain is the most cause of adult disability throughout life. Its prevalence widens in young adults. Background of this pathology can be multifactorial. One of the most common is poor core stability and overloading of the local tissues as a result.
Among treatment methods stabilizing training is commonly used with good effects. This form of therapy affects the transverse abdomen (TrA) and multifidus (MF) muscles. To assess these structures several methods can be applied, e.g. sonofeedback.
All participants will be randomly divided into two groups:
- Training group (TG)
- Control group (CG)
Outcome measure:
Pre- and post-therapy outcome measure will be done. It will include:
- ultrasound (sonofeedback) of the TrA and MF
- Oswestry Disability Index questionnaire (ODI)
- subjective pain scale - Numeric Rating Scale (NRS)
Intervention:
Core stability training including 4 exercise positions, each of 15 repetitions, 4 sets. Once a day, 5 times a week, 20 sessions in total (4 weeks).
Our hypothesis claims that the core muscles morphology will change over the training process duration, in result, the analgesic effect will be achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Core stability training4-week core stability training |
| Control group | No intervention | –Standard physical therapy |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- low back pain
- age from 18 to 30 years old
- written consent of the participants
Key exclusion criteria (5 listed)
- injuries of the spine
- fractures of the spine
- surgery interventions in the spine region prior to the study
- psychiatric disorders
- neurologic 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 |
|---|---|---|
| Core stability training20 sessions of specific core stability exercise with no external loading. | Other | Training group |
Primary outcome
Ultrasound
Time frame: 5 minutes
Non-invasive measure of the TrA and MF muscles
Pain level
Time frame: 1 minute
Numeric Rating Scale. Picking the number on a scale from 0 to 10.
Questionnaire
Time frame: 5 minutes
Oswestry Disability Index questionnaire - subjective disability measure throughout daily living activities.
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 12 Jan 2021.
- Background: PubMed 28160750Masse-Alarie H, Beaulieu LD, Preuss R, Schneider C. Repetitive peripheral magnetic neurostimulation of multifidus muscles combined with motor training influences spine motor control and chronic low back pain. Clin Neurophysiol. 2017 Mar;128(3):442-453. doi: 10.1016/j.clinph.2016.12.020. Epub 2016 Dec 28.
- Background: PubMed 28459281Hides JA, Walsh JC, Smith MMF, Mendis MD. Self-Managed Exercises, Fitness and Strength Training, and Multifidus Muscle Size in Elite Footballers. J Athl Train. 2017 Jul;52(7):649-655. doi: 10.4085/1062-6050-52.3.13. Epub 2017 May 1.
- Background: PubMed 30568484Finta R, Nagy E, Bender T. The effect of diaphragm training on lumbar stabilizer muscles: a new concept for improving segmental stability in the case of low back pain. J Pain Res. 2018 Nov 28;11:3031-3045. doi: 10.2147/JPR.S181610. eCollection 2018.
- Individual participant dataSharing planned: No
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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 Core stability training in people with Low Back Pain, Mechanical and Low Back Pain, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
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 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 12 Jan 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 Poland. 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?
Ultrasound (time frame: 5 minutes). The study lists 3 primary outcomes in all. 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 NCT04554563, which also lists 3 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 12 Jan 2021.