Stabilizing Training in Degenerative Disc Disease

January 15, 2020 updated by: Błażej Cieślik, University School of Physical Education in Wroclaw

Stabilizing Training Effects in Relation With Progression Level in Young Degenerative Disc Disease Individuals

This study evaluates efficacy of stabilizing training of deep core muscles in the lumbar spine in degenerative disc disease subjects, considering the progression level of degenerative disc disease: protrusion or extrusion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Degenerative disc disease (DDD) is one of the causes of low back pain, and contributes to increasing the socio-economic problem. Depending on the reason for the dysfunction, various classifications describing the level of advancement are used. Literature on the subject commonly uses the division into protrusion and extrusion of the intervertebral disc, as approved by the American Society of Neuroradiology.

Stabilizing training is one of the forms of conservative treatment of lumbar pain, alongside manual treatment or techniques from the field of chiropractics or physiotherapy. It is thought that the proper stabilization of this region of the body is crucial for coping with pain.

Therefore, the aim of the study was to assess the effectiveness of stabilizing training of deep core muscles in the lumbar spine in subjects in the age of 20-35 years, considering the progression level of degenerative disc disease: protrusion or extrusion, on the basis of the clinical condition.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Lower Silesia
      • Wrocław, Lower Silesia, Poland, 50-305
        • theMedicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

All the subjects undergo imaging examination in the form of MRI, whose results will be interpreted by a radiologist. Each person will be classified according to the current damage to the intervertebral disc as recommended by the American Society of Neuroradiology: protrusion or extrusion of the intervertebral disc.

Inclusion Criteria:

  • disc disease located in the lumbar region of the spine confirmed by the MRI
  • subacute stage of the disease
  • age 20-35 years

Exclusion Criteria:

  • advanced degenerative-deformatory changes of the spine
  • previous fracture of the spine
  • neurologic deficits in lower limbs or pelvis
  • spondylolisthesis
  • transitional vertebra
  • rheumatic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Protrusion Group
20 session of stabilizing training based on the principles developed by Richardson over four weeks.
Behavioral: Stabilizing training
The training will include the activation of the lumbar multifidus muscle (m. multifudus) and the transverse abdominal muscle (m. transversus abdominis). The performance of the individual stages of the training will be based on Richardson's methodology. One session will comprise 4 sets in which the patient will be asked to do pelvic tilts (draw-in) with simultaneous full exhalation, thus activating the aforementioned muscle groups in different positions: a) prone b) supine with lower extremities flexed c) quadruped d) standing back to the wall. The subjects will perform 3 series consisting of 10 repeats, each of which will last ca. 10 seconds.
Experimental: Extrusion Group
20 session of stabilizing training based on the principles developed by Richardson over four weeks.
Behavioral: Stabilizing training
The training will include the activation of the lumbar multifidus muscle (m. multifudus) and the transverse abdominal muscle (m. transversus abdominis). The performance of the individual stages of the training will be based on Richardson's methodology. One session will comprise 4 sets in which the patient will be asked to do pelvic tilts (draw-in) with simultaneous full exhalation, thus activating the aforementioned muscle groups in different positions: a) prone b) supine with lower extremities flexed c) quadruped d) standing back to the wall. The subjects will perform 3 series consisting of 10 repeats, each of which will last ca. 10 seconds.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Oswestry Disability Index
Time Frame: 15 minutes

The Oswestry Disability Index (ODI) is a valid and reliable assessment tool used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten sections concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. After completing, the score is calculated by by summing scores from all sections (total maximum points=50). Total results are calculated as a percentage. The higher the score, the subject's condition is worse.

The results are interpreted as follows:

0% to 20%: minimal disability 21%-40%: moderate disability 41%-60%: severe disability 61%-80%: crippled 81%-100%:These patients are either bed-bound or exaggerating their symptoms.
15 minutes
Range of motion evaluation
Time Frame: 15 minutes
Range of motion will be evaluated SpinalMouse®. It is a non-invasive device used for assessing spinal mobility, whose reliability has been confirmed by studies. The measurement records the flexion and extension range of motion, and the test measure the total mobility from maximal flexion to maximal extension. Three measurements will be taken, and for statistical purposes their mean value will be calculated.
15 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The passive lumbar extension test
Time Frame: 10 minutes
The passive lumbar extension test (PLE) is a tool for assessing the instability in the lumbar section of the spine. It is is the most suitable test for detecting lumbar instability, thanks to its excellent diagnostic accuracy, and good reliability
10 minutes
Straight leg raise test
Time Frame: 10 minutes
Straight leg raise (SLR) test is considered by researchers to be sensitive and specific in diagnosing damage to the peripheral nervous system. The subject's lower limb with the knee extended was passively raised until potential symptoms were triggered, although not more than 60° of flexion in the hip joint, which, according to Kapandji, causes the maximum stretching of nerve structures.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University School of Physical Education in Wroclaw

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Błażej Cieślik, PhD., University School of Physical Education, Wroclaw, Poland
  • Principal Investigator: Tomasz Kuligowski, PhD., University School of Physical Education, Wroclaw, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MED23/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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