Effects of Exercise Intervention in Patients With Spondylolisthesis Related LBP

NCT ID: NCT01985776

Last Updated: 2018-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain Spondylolisthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise intervention

Patients will functional stabilisation exercise for the trunk.

Group Type ACTIVE_COMPARATOR

Exercise intervention

Intervention Type PROCEDURE

Functional stabilisation exercise for the trunk.

Exercise and e-stim

Patients will receive exercise intervention and electrical stimulation simultaneously.

Group Type ACTIVE_COMPARATOR

Exercise and e-stim

Intervention Type PROCEDURE

Functional stabilisation exercise for the trunk and electrical stimulation at the same time.

Patients control

Patients will not receive any treatment but could use compression belt as per usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthy control

Healthy asymptomatic participants who will not receive any treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise intervention

Functional stabilisation exercise for the trunk.

Intervention Type PROCEDURE

Exercise and e-stim

Functional stabilisation exercise for the trunk and electrical stimulation at the same time.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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S2P, Science to Practice, Ltd.

OTHER

Sponsor Role collaborator

University of Primorska

OTHER

Sponsor Role lead

Responsible Party

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Nejc Sarabon

Assoc. Prof. Dr. Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nejc Sarabon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Primorska

Locations

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Orthopaedic Hospital Valdoltra

Ankaran, , Slovenia

Site Status

University of Primorska, Science and Research Centre of Koper, Institute for Kinesiology Research

Koper, , Slovenia

Site Status

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status

University Medical Centre Maribor

Maribor, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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UP-FVZ-ExerciseSpondylolisth

Identifier Type: -

Identifier Source: org_study_id

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