Clinical trial NCT01985776: Effects of Exercise Intervention in Patients With Spondylolisthesis Related LBP
Official title: Effects of Exercise Intervention in Patients With Low Back Pain Due to Spondylolytic Spondylolisthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Spondylolisthesis
Keywords: Exercise
Electric Stimulation
Lead sponsor: University of Primorska
Sponsor class: OTHER
Collaborators: name: S2P, Science to Practice, Ltd.
First posted: 2013-11-15
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in measures of neuromuscular functions of the trunk
timeFrame: Change from baseline values at 9 weeks
Secondary outcomes:
measure: Changes in Oswestry questionnaire score
timeFrame: Change from baseline values at 9 weeks
measure: Change in Posture parameters
timeFrame: Change from baseline values at 9 weeks
Other outcomes:
Locations:
city: Ankaran
country: Slovenia
facility: Orthopaedic Hospital Valdoltra
city: Koper
country: Slovenia
facility: University of Primorska, Science and Research Centre of Koper, Institute for Kinesiology Research
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Maribor
country: Slovenia
facility: University Medical Centre Maribor
Study officials:
affiliation: University of Primorska
name: Nejc Sarabon, PhD
role: PRINCIPAL_INVESTIGATOR
References: