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Degenerative Disc DiseaseNCT04119466

Stabilizing Training in Degenerative Disc Disease

A study testing Stabilizing training in people with Degenerative Disc Disease and Protrusion, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 35 years
What is being tested?
Stabilizing training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 sitePoland
Study dates
1 Sep 2019to 15 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • theMedicine

    Wroclaw, Lower Silesian Voivodeship, 50-305

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Being tested
Stabilizing training
Keywords
degenerative disc disease, stabilizing training, protrusion, extrusion
Medical subject headings
Intervertebral Disc Degeneration, Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stabilizing trainingBehavioural

    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.

Study groups in NCT04119466
Study groupRoleWhat they receive
Protrusion GroupExperimental20 session of stabilizing training based on the principles developed by Richardson over four weeks.
Receives: Behavioral: Stabilizing training
Extrusion GroupExperimental20 session of stabilizing training based on the principles developed by Richardson over four weeks.
Receives: Behavioral: Stabilizing training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 15 minutes

  2. 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.

    Measured: 15 minutes

Secondary outcomes (2)

  1. 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

    Measured: 10 minutes

  2. 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.

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2019
  2. Study start1 Sep 2019
  3. Primary completion15 Jan 2020
  4. Study completion15 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04119466
Sponsor's protocol ID
MED23/2019
Status last verified
Jan 2020
First submitted
6 Oct 2019
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26377578

  • 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.

    PubMed 23948426

  • 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.

    PubMed 17885181

  • 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.

    PubMed 24534392

  • 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.

    PubMed 21621724

  • 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.

    PubMed 18164468

  • 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.

    PubMed 24361346

Questions about this trial

What is this clinical trial studying?

A study testing Stabilizing training in people with Degenerative Disc Disease and Protrusion, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Oswestry Disability Index (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04119466, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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