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The Effect of Core Stability Training on Deep Stabilizing Muscles.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04554563
Recruitment Status : Recruiting
First Posted : September 18, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Tomasz Kuligowski, University School of Physical Education in Wroclaw

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.


Condition or disease Intervention/treatment Phase
Low Back Pain, Mechanical Low Back Pain Low Back Pain, Postural Other: Core stability training Not Applicable

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:

  1. Training group (TG)
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Core Stability Training on the Transverse Abdomen and Multifidus Muscles Morphology in Young Non-specific Low Back Pain Individuals.
Actual Study Start Date : September 12, 2020
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : January 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Training group
4-week core stability training
Other: Core stability training
20 sessions of specific core stability exercise with no external loading.

No Intervention: Control group
Standard physical therapy



Primary Outcome Measures :
  1. Ultrasound [ Time Frame: 5 minutes ]
    Non-invasive measure of the TrA and MF muscles

  2. Pain level [ Time Frame: 1 minute ]
    Numeric Rating Scale. Picking the number on a scale from 0 to 10.

  3. Questionnaire [ Time Frame: 5 minutes ]
    Oswestry Disability Index questionnaire - subjective disability measure throughout daily living activities.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04554563


Contacts
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Contact: Tomasz Kuligowski, PHD +48782602862 tomasz.kuligowski@awf.wroc.pl

Locations
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Poland
Klinika Fizjoterapii Recruiting
Wrocław, Dolnośląskie, Poland, 50-234
Contact: Tomasz Kuligowski, PhD    +48782602862    tomasz.kuligowski@awf.wroc.pl   
Principal Investigator: Tomasz Kuligowski, PhD         
Sponsors and Collaborators
University School of Physical Education in Wroclaw
Publications:
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Responsible Party: Tomasz Kuligowski, PHD., Assistant Professor, University School of Physical Education in Wroclaw
ClinicalTrials.gov Identifier: NCT04554563    
Other Study ID Numbers: USG TrA MF
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tomasz Kuligowski, University School of Physical Education in Wroclaw:
low back pain
ultrasound
sonofeedback
core stability
lumbar spine
transverse abdomen
multifidus
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations