Effects of Exercise Intervention in Patients With Spondylolisthesis Related LBP (EXER-SPO-TNC)

February 7, 2018 updated by: Nejc Sarabon, University of Primorska

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ankaran, Slovenia, 6280
        • Orthopaedic Hospital Valdoltra
      • Koper, Slovenia, 6000
        • University of Primorska, Science and Research Centre of Koper, Institute for Kinesiology Research
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana
      • Maribor, Slovenia, 2000
        • University Medical Centre Maribor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise intervention
Patients will functional stabilisation exercise for the trunk.
Procedure: Exercise intervention
Functional stabilisation exercise for the trunk.
Active Comparator: Exercise and e-stim
Patients will receive exercise intervention and electrical stimulation simultaneously.
Procedure: Exercise and e-stim
Functional stabilisation exercise for the trunk and electrical stimulation at the same time.
No Intervention: Patients control
Patients will not receive any treatment but could use compression belt as per usual.
No Intervention: Healthy control
Healthy asymptomatic participants who will not receive any treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in measures of neuromuscular functions of the trunk
Time Frame: 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
Change from baseline values at 9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Oswestry questionnaire score
Time Frame: 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 from baseline values at 9 weeks
Change in Posture parameters
Time Frame: Change from baseline values at 9 weeks
Angular and linear posture measures in frontal and sagittal plane.
Change from baseline values at 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Primorska

Collaborators

S2P, Science to Practice, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP-FVZ-ExerciseSpondylolisth

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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