Effects of Exercise Intervention in Patients With Spondylolisthesis Related LBP

Low Back Pain Clinical Trial

— EXER-SPO-TNC  

Official title:

Effects of Exercise Intervention in Patients With Low Back Pain Due to Spondylolytic Spondylolisthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985776
• Other study ID #: UP-FVZ-ExerciseSpondylolisth
• Status: Completed
• Phase: N/A
• First received: October 30, 2013
• Last updated: February 7, 2018
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2018
• Source: University of Primorska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Spondylolisthesis

Intervention

Procedure:
• Exercise intervention
Functional stabilisation exercise for the trunk.
• Exercise and e-stim
Functional stabilisation exercise for the trunk and electrical stimulation at the same time.

Locations

Country	Name	City	State
Slovenia	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Primorska	S2P, Ltd.

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in measures of neuromuscular functions of the trunk	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	Change from baseline values at 9 weeks
Secondary	Changes in Oswestry questionnaire score	Oswestry Low Back Pain Questionnaire commolny used by clinicians and researchers to quantify disability for low back pain.	Change from baseline values at 9 weeks
Secondary	Change in Posture parameters	Angular and linear posture measures in frontal and sagittal plane.	Change from baseline values at 9 weeks

External Links

•   Orthopaedic Hospital Valdoltra