Effects of Exercise Intervention in Patients With Spondylolisthesis Related LBP (EXER-SPO-TNC)
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|ClinicalTrials.gov Identifier: NCT01985776|
Recruitment Status : Completed
First Posted : November 15, 2013
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Spondylolisthesis||Procedure: Exercise intervention Procedure: Exercise and e-stim||Not Applicable|
Low back pain is known to affect a considerable portion (> 75%) of the society, causing enormous financial burden for the healthcare systems.
Exercise interventions incorporated into low back pain patients rehabilitation protocols are known as successful treatment strategies, but ore often focused on strength training and not on functional stabilization. Spondylolytic spondylolisthesis is one of the most known types of spine instabilities. To date, no studies examined the effects of exercise intervention on patients with low back pain due to spondylolytic spondylolisthesis. Research will be carried out as a cross-sectional study, where patients with spondylolytic spondylolisthesis will be randomly arranged in one controlled and two experimental groups. For the forth group healthy asymptomatic participants will be recruited.
Exercise intervention will last 12 weeks with a frequency of three times a week and duration of 60 minutes per training unit. Exercise intervention will include congregated set of trunk stabilisation exercises, starting with simple isometric tasks. Dynamic and more complex movements will be added progressively to achieve whole body tasks involving fast and sudden movements.
Neuromuscular functions of the trunk will be measured before and after the intervention.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Exercise Intervention in Patients With Low Back Pain Due to Spondylolytic Spondylolisthesis|
|Actual Study Start Date :||June 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: Exercise intervention
Patients will functional stabilisation exercise for the trunk.
Procedure: Exercise intervention
Functional stabilisation exercise for the trunk.
Active Comparator: Exercise and e-stim
Patients will receive exercise intervention and electrical stimulation simultaneously.
Procedure: Exercise and e-stim
Functional stabilisation exercise for the trunk and electrical stimulation at the same time.
No Intervention: Patients control
Patients will not receive any treatment but could use compression belt as per usual.
No Intervention: Healthy control
Healthy asymptomatic participants who will not receive any treatment.
- Changes in measures of neuromuscular functions of the trunk [ Time Frame: Change from baseline values at 9 weeks ]
Set of tests that objectively evaluate the neuromuscular functions of the trunk.
- Ability to reposition the trunk position during forward bent
- Maximal voluntary contraction during trunk flexion, extension and lateral flexion
- Muscle endurance during isometric trunk extension.
- Trunk's muscles activation during sudden loading and fast arm movement
- Single leg stance
- Leg symmetry during squat
- Hip and spine flexibility
- Changes in Oswestry questionnaire score [ Time Frame: Change from baseline values at 9 weeks ]Oswestry Low Back Pain Questionnaire commolny used by clinicians and researchers to quantify disability for low back pain.
- Change in Posture parameters [ Time Frame: Change from baseline values at 9 weeks ]Angular and linear posture measures in frontal and sagittal plane.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985776
|Orthopaedic Hospital Valdoltra|
|Ankaran, Slovenia, 6280|
|University of Primorska, Science and Research Centre of Koper, Institute for Kinesiology Research|
|Koper, Slovenia, 6000|
|University Medical Centre Ljubljana|
|Ljubljana, Slovenia, 1000|
|University Medical Centre Maribor|
|Maribor, Slovenia, 2000|
|Principal Investigator:||Nejc Sarabon, PhD||University of Primorska|