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

Primary Purpose

Low Back Pain, Spondylolisthesis

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Exercise intervention
Exercise and e-stim
Sponsored by
University of Primorska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Exercise, Electric Stimulation

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Orthopaedic Hospital Valdoltra
  • University of Primorska, Science and Research Centre of Koper, Institute for Kinesiology Research
  • University Medical Centre Ljubljana
  • University Medical Centre Maribor

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

No Intervention

No Intervention

Arm Label

Exercise intervention

Exercise and e-stim

Patients control

Healthy control

Arm Description

Patients will functional stabilisation exercise for the trunk.

Patients will receive exercise intervention and electrical stimulation simultaneously.

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

Healthy asymptomatic participants who will not receive any treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in Oswestry questionnaire score
Oswestry Low Back Pain Questionnaire commolny used by clinicians and researchers to quantify disability for low back pain.
Change in Posture parameters
Angular and linear posture measures in frontal and sagittal plane.

Full Information

First Posted
October 30, 2013
Last Updated
February 7, 2018
Sponsor
University of Primorska
Collaborators
S2P, Science to Practice, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01985776
Brief Title
Effects of Exercise Intervention in Patients With Spondylolisthesis Related LBP
Acronym
EXER-SPO-TNC
Official Title
Effects of Exercise Intervention in Patients With Low Back Pain Due to Spondylolytic Spondylolisthesis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Primorska
Collaborators
S2P, Science to Practice, Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Spondylolisthesis
Keywords
Exercise, Electric Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise intervention
Arm Type
Active Comparator
Arm Description
Patients will functional stabilisation exercise for the trunk.
Arm Title
Exercise and e-stim
Arm Type
Active Comparator
Arm Description
Patients will receive exercise intervention and electrical stimulation simultaneously.
Arm Title
Patients control
Arm Type
No Intervention
Arm Description
Patients will not receive any treatment but could use compression belt as per usual.
Arm Title
Healthy control
Arm Type
No Intervention
Arm Description
Healthy asymptomatic participants who will not receive any treatment.
Intervention Type
Procedure
Intervention Name(s)
Exercise intervention
Intervention Description
Functional stabilisation exercise for the trunk.
Intervention Type
Procedure
Intervention Name(s)
Exercise and e-stim
Intervention Description
Functional stabilisation exercise for the trunk and electrical stimulation at the same time.
Primary Outcome Measure Information:
Title
Changes in measures of neuromuscular functions of the trunk
Description
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
Time Frame
Change from baseline values at 9 weeks
Secondary Outcome Measure Information:
Title
Changes in Oswestry questionnaire score
Description
Oswestry Low Back Pain Questionnaire commolny used by clinicians and researchers to quantify disability for low back pain.
Time Frame
Change from baseline values at 9 weeks
Title
Change in Posture parameters
Description
Angular and linear posture measures in frontal and sagittal plane.
Time Frame
Change from baseline values at 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nejc Sarabon, PhD
Organizational Affiliation
University of Primorska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic Hospital Valdoltra
City
Ankaran
ZIP/Postal Code
6280
Country
Slovenia
Facility Name
University of Primorska, Science and Research Centre of Koper, Institute for Kinesiology Research
City
Koper
ZIP/Postal Code
6000
Country
Slovenia
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
University Medical Centre Maribor
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia

12. IPD Sharing Statement

Links:
URL
http://www.slovenia-medical.com/en/about-us/medical-institutions/orthopaedic-hospital-valdoltra
Description
Orthopaedic Hospital Valdoltra

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Effects of Exercise Intervention in Patients With Spondylolisthesis Related LBP

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