The Effect of Core Stability Training on Deep Stabilizing Muscles.
Primary Purpose
Low Back Pain, Mechanical, Low Back Pain, Low Back Pain, Postural
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Core stability training
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain, Mechanical focused on measuring low back pain, ultrasound, sonofeedback, core stability, lumbar spine, transverse abdomen, multifidus
Eligibility Criteria
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
Sites / Locations
- Klinika Fizjoterapii
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training group
Control group
Arm Description
4-week core stability training
Standard physical therapy
Outcomes
Primary Outcome Measures
Ultrasound
Non-invasive measure of the TrA and MF muscles
Pain level
Numeric Rating Scale. Picking the number on a scale from 0 to 10.
Questionnaire
Oswestry Disability Index questionnaire - subjective disability measure throughout daily living activities.
Secondary Outcome Measures
Full Information
NCT ID
NCT04554563
First Posted
September 12, 2020
Last Updated
January 8, 2021
Sponsor
Wroclaw University of Health and Sport Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04554563
Brief Title
The Effect of Core Stability Training on Deep Stabilizing Muscles.
Official Title
The Effect of Core Stability Training on the Transverse Abdomen and Multifidus Muscles Morphology in Young Non-specific Low Back Pain Individuals.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 12, 2020 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
January 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw University of Health and Sport Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical, Low Back Pain, Low Back Pain, Postural
Keywords
low back pain, ultrasound, sonofeedback, core stability, lumbar spine, transverse abdomen, multifidus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training group
Arm Type
Experimental
Arm Description
4-week core stability training
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard physical therapy
Intervention Type
Other
Intervention Name(s)
Core stability training
Intervention Description
20 sessions of specific core stability exercise with no external loading.
Primary Outcome Measure Information:
Title
Ultrasound
Description
Non-invasive measure of the TrA and MF muscles
Time Frame
5 minutes
Title
Pain level
Description
Numeric Rating Scale. Picking the number on a scale from 0 to 10.
Time Frame
1 minute
Title
Questionnaire
Description
Oswestry Disability Index questionnaire - subjective disability measure throughout daily living activities.
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Klinika Fizjoterapii
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
50-234
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28160750
Citation
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.
Results Reference
background
PubMed Identifier
28459281
Citation
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.
Results Reference
background
PubMed Identifier
30568484
Citation
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.
Results Reference
background
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The Effect of Core Stability Training on Deep Stabilizing Muscles.
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