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Completed

NCT Number: NCT01985776

Effects of Exercise Intervention in Patients With Spondylolisthesis Related LBP

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.

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Key information

Conditions

Low Back Pain Back Pain Behavior Bone Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Hospital Valdoltra, Ankaran, Slovenia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise intervention

Procedure

Functional stabilisation exercise for the trunk.

Exercise and e-stim

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Change in Posture parameters

    Time frame: Change from baseline values at 9 weeks

    Angular and linear posture measures in frontal and sagittal plane.

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Collaborators

  • S2P, Science to Practice, Ltd.

Registry information

Official study title

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

Acronym: EXER-SPO-TNC

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 15, 2013
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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