search
Back to results

Stabilizing Training in Degenerative Disc Disease

Primary Purpose

Degenerative Disc Disease, Protrusion, Extrusion of Migrated Disc

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Stabilizing training
Sponsored by
Wroclaw University of Health and Sport Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring degenerative disc disease, stabilizing training, protrusion, extrusion

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • theMedicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Protrusion Group

Extrusion Group

Arm Description

20 session of stabilizing training based on the principles developed by Richardson over four weeks.

20 session of stabilizing training based on the principles developed by Richardson over four weeks.

Outcomes

Primary Outcome Measures

The Oswestry Disability Index
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.
Range of motion evaluation
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.

Secondary Outcome Measures

The passive lumbar extension test
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
Straight leg raise test
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.

Full Information

First Posted
October 6, 2019
Last Updated
January 15, 2020
Sponsor
Wroclaw University of Health and Sport Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04119466
Brief Title
Stabilizing Training in Degenerative Disc Disease
Official Title
Stabilizing Training Effects in Relation With Progression Level in Young Degenerative Disc Disease Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
January 15, 2020 (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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Protrusion, Extrusion of Migrated Disc, Hernia
Keywords
degenerative disc disease, stabilizing training, protrusion, extrusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protrusion Group
Arm Type
Experimental
Arm Description
20 session of stabilizing training based on the principles developed by Richardson over four weeks.
Arm Title
Extrusion Group
Arm Type
Experimental
Arm Description
20 session of stabilizing training based on the principles developed by Richardson over four weeks.
Intervention Type
Behavioral
Intervention Name(s)
Stabilizing training
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Oswestry Disability Index
Description
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.
Time Frame
15 minutes
Title
Range of motion evaluation
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
The passive lumbar extension test
Description
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
Time Frame
10 minutes
Title
Straight leg raise test
Description
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.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Błażej Cieślik, PhD.
Organizational Affiliation
University School of Physical Education, Wroclaw, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tomasz Kuligowski, PhD.
Organizational Affiliation
University School of Physical Education, Wroclaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
theMedicine
City
Wrocław
State/Province
Lower Silesia
ZIP/Postal Code
50-305
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26377578
Citation
Altinkaya N, Cekinmez M. Lumbar multifidus muscle changes in unilateral lumbar disc herniation using magnetic resonance imaging. Skeletal Radiol. 2016 Jan;45(1):73-7. doi: 10.1007/s00256-015-2252-z. Epub 2015 Sep 16.
Results Reference
background
PubMed Identifier
23948426
Citation
Aluko A, DeSouza L, Peacock J. The effect of core stability exercises on variations in acceleration of trunk movement, pain, and disability during an episode of acute nonspecific low back pain: a pilot clinical trial. J Manipulative Physiol Ther. 2013 Oct;36(8):497-504.e1-3. doi: 10.1016/j.jmpt.2012.12.012. Epub 2013 Aug 12.
Results Reference
background
PubMed Identifier
17885181
Citation
Leone A, Guglielmi G, Cassar-Pullicino VN, Bonomo L. Lumbar intervertebral instability: a review. Radiology. 2007 Oct;245(1):62-77. doi: 10.1148/radiol.2451051359.
Results Reference
background
PubMed Identifier
24534392
Citation
Baek SO, Cho HK, Jung GS, Son SM, Cho YW, Ahn SH. Verification of an optimized stimulation point on the abdominal wall for transcutaneous neuromuscular electrical stimulation for activation of deep lumbar stabilizing muscles. Spine J. 2014 Sep 1;14(9):2178-83. doi: 10.1016/j.spinee.2014.02.016. Epub 2014 Feb 14.
Results Reference
background
PubMed Identifier
21621724
Citation
Capra F, Vanti C, Donati R, Tombetti S, O'Reilly C, Pillastrini P. Validity of the straight-leg raise test for patients with sciatic pain with or without lumbar pain using magnetic resonance imaging results as a reference standard. J Manipulative Physiol Ther. 2011 May;34(4):231-8. doi: 10.1016/j.jmpt.2011.04.010. Epub 2011 May 5.
Results Reference
background
PubMed Identifier
18164468
Citation
Dagenais S, Mayer J, Haldeman S, Borg-Stein J. Evidence-informed management of chronic low back pain with prolotherapy. Spine J. 2008 Jan-Feb;8(1):203-12. doi: 10.1016/j.spinee.2007.10.021.
Results Reference
background
PubMed Identifier
24361346
Citation
Daghighi MH, Pouriesa M, Maleki M, Fouladi DF, Pezeshki MZ, Mazaheri Khameneh R, Bazzazi AM. Migration patterns of herniated disc fragments: a study on 1,020 patients with extruded lumbar disc herniation. Spine J. 2014 Sep 1;14(9):1970-7. doi: 10.1016/j.spinee.2013.11.056. Epub 2013 Dec 18.
Results Reference
background

Learn more about this trial

Stabilizing Training in Degenerative Disc Disease

We'll reach out to this number within 24 hrs