Overview

This trial is active, not recruiting.

Conditions low back pain, spondylolisthesis
Treatments exercise intervention, exercise and e-stim
Sponsor University of Primorska
Start date June 2013
End date September 2014
Trial size 48 participants
Trial identifier NCT01985776, L5-4293(B))

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients will functional stabilisation exercise for the trunk.
exercise intervention
Functional stabilisation exercise for the trunk.
(Active Comparator)
Patients will receive exercise intervention and electrical stimulation simultaneously.
exercise and e-stim
Functional stabilisation exercise for the trunk and electrical stimulation at the same time.
(No Intervention)
Patients will not receive any treatment but could use compression belt as per usual.
(No Intervention)
Healthy asymptomatic participants who will not receive any treatment.

Primary Outcomes

Measure
Changes in measures of neuromuscular functions of the trunk
time frame: Change from baseline values at 9 weeks

Secondary Outcomes

Measure
Changes in Oswestry questionnaire
time frame: Change from baseline values at 9 weeks
Change in Posture
time frame: Change from baseline values at 9 weeks

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

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.

Additional Information

Official title Effects of Exercise Intervention on Patients With Low Back Pain Due to Spondylolytic Spondylolisthesis.
Principal investigator Nejc Sarabon, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by University of Primorska.