The Effect of Core Stability Training on Deep Stabilizing... | NCT04554563

Studies
The Effect of Core Stability Training on Deep Stabilizing Muscles.

NCT04554563

Sponsor

Wroclaw University of Health and Sport Sciences

Status

Completed

Last Update Posted

Jan 12, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Low Back Pain, Mechanical
Low Back Pain
Low Back Pain, Postural

Interventions

Core stability training

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 12, 2020Actual

Primary Completion Date

Dec 20, 2020Actual

Completion Date

Jan 8, 2021Actual

First Submitted Date

Sep 12, 2020

First Submission Date that Met QC Criteria

Sep 12, 2020

First Posted Date

Sep 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2021

Last Update Posted Date

Jan 12, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tomasz Kuligowski, PHD., Assistant Professor, Wroclaw University of Health and Sport SciencesPrincipal Investigator

Lead Sponsor

Wroclaw University of Health and Sport SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Training group	Experimental	4-week core stability training	Other: Core stability training
Control group	No Intervention	Standard physical therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Core stability training	Other	20 sessions of specific core stability exercise with no external loading.	Training group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ultrasound	Non-invasive measure of the TrA and MF muscles	5 minutes
Pain level	Numeric Rating Scale. Picking the number on a scale from 0 to 10.	1 minute
Questionnaire	Oswestry Disability Index questionnaire - subjective disability measure throughout daily living activities.	5 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinika Fizjoterapii		Wroclaw	Lower Silesian Voivodeship	50-234	Poland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28160750	Background	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.
28459281	Background

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms