- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04554563
The Effect of Core Stability Training on Deep Stabilizing Muscles.
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dolnośląskie
-
Wrocław, Dolnośląskie, Poland, 50-234
- Klinika Fizjoterapii
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- low back pain
- age from 18 to 30 years old
- written consent of the participants
Exclusion Criteria:
- injuries of the spine
- fractures of the spine
- surgery interventions in the spine region prior to the study
- psychiatric disorders
- neurologic disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training group
4-week core stability training
|
20 sessions of specific core stability exercise with no external loading.
|
No Intervention: Control group
Standard physical therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasound
Time Frame: 5 minutes
|
Non-invasive measure of the TrA and MF muscles
|
5 minutes
|
Pain level
Time Frame: 1 minute
|
Numeric Rating Scale.
Picking the number on a scale from 0 to 10.
|
1 minute
|
Questionnaire
Time Frame: 5 minutes
|
Oswestry Disability Index questionnaire - subjective disability measure throughout daily living activities.
|
5 minutes
|
Collaborators and Investigators
Publications and helpful links
General 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.
- Hides 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.
- Finta 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USG TrA MF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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