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NCT Number: NCT04119466

Stabilizing Training in Degenerative Disc Disease

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Extrusion of Migrated Disc Hernia Intervertebral Disc Degeneration Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Protrusion Spinal Diseases

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

theMedicine

Wroclaw, Lower Silesian Voivodeship, 50-305, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stabilizing training

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Wroclaw University of Health and Sport Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2019
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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