NCT04119466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

October 6, 2019

Last Update Submit

January 15, 2020

Conditions

Degenerative Disc DiseaseProtrusionExtrusion of Migrated DiscHernia

Keywords

degenerative disc diseasestabilizing trainingprotrusionextrusion

Outcome Measures

Primary Outcomes (2)

  • 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.

    15 minutes

  • 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.

    15 minutes

Secondary Outcomes (2)

  • The passive lumbar extension test

    10 minutes

  • Straight leg raise test

    10 minutes

Study Arms (2)

Protrusion Group

EXPERIMENTAL

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

Behavioral: Stabilizing training

Extrusion Group

EXPERIMENTAL

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

Behavioral: Stabilizing training

Interventions

Stabilizing trainingBEHAVIORAL

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.

Extrusion GroupProtrusion Group

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

theMedicine

Wroclaw, Lower Silesian Voivodeship, 50-305, Poland

Location

Related Publications (7)

  • 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.

    PMID: 26377578BACKGROUND

  • 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.

    PMID: 23948426BACKGROUND

  • 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.

    PMID: 17885181BACKGROUND

  • 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.

    PMID: 24534392BACKGROUND

  • 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.

    PMID: 21621724BACKGROUND

  • 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.

    PMID: 18164468BACKGROUND

  • 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.

    PMID: 24361346BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc DegenerationHernia

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Błażej Cieślik, PhD.

    University School of Physical Education, Wroclaw, Poland

    PRINCIPAL INVESTIGATOR

  • Tomasz Kuligowski, PhD.

    University School of Physical Education, Wroclaw, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 6, 2019

First Posted

October 8, 2019

Study Start

September 1, 2019

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)