Effects of Exercise Intervention in Patients With Spondylolisthesis Related LBP

Not Applicable

Completed

• Conditions: Low Back Pain; Spondylolisthesis
• Interventions: Procedure: Exercise intervention; Procedure: Exercise and e-stim

• Registration Number: NCT01985776
• Lead Sponsor: University of Primorska

Brief Summary

The first purpose of this study is to define parameters of the trunk neuromuscular functions that are pathologically altered in patients with low back pain due to spondylolytic spondylolisthesis. The second and also the main purpose of the study is to examine the effects of exercise intervention on patients with low back pain due to spondylolytic spondylolisthesis. Our overall hypothesis is that specific exercise intervention will improve neuromuscular functions of the trunk in patients with low back pain due to spondylolytic spondylolisthesis.

Detailed Description

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-15
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-07
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Low back pain presence for at least three months.
• Age between 20 and 60 years.
• Isthmic Spondylolisthesis (1st and 2nd level according to Meyerding) at L5/S1 and L4/L5.
• Body mass index below 30.
• without neurological pathological conditions.

Exclusion Criteria

• Intermittent claudication pain.
• History of operational treatment of the lumbar spine.
• Traumatic, oncological, infectional pathology of the spine
• Degenerative stenosis of the lumbar spinal canal.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Exercise intervention	Exercise intervention	Patients will functional stabilisation exercise for the trunk.
Exercise and e-stim	Exercise and e-stim	Patients will receive exercise intervention and electrical stimulation simultaneously.

Primary Outcome Measures

Name	Time	Method
Changes in measures of neuromuscular functions of the trunk	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

Secondary Outcome Measures

Name	Time	Method
Changes in Oswestry questionnaire score	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	Change from baseline values at 9 weeks	Angular and linear posture measures in frontal and sagittal plane.

Trial Locations

Locations (4)

Orthopaedic Hospital Valdoltra; 🇸🇮 Ankaran, Slovenia

University of Primorska, Science and Research Centre of Koper, Institute for Kinesiology Research; 🇸🇮 Koper, Slovenia

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia

University Medical Centre Maribor; 🇸🇮 Maribor, Slovenia