Effects of Exercise Intervention on Patients With Low Back Pain Due to Spondylolytic Spondylolisthesis. (ExerciseLBP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nejc Sarabon, University of Primorska
ClinicalTrials.gov Identifier:
NCT01985776
First received: October 30, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Low Back Pain
Spondylolisthesis
Procedure: Exercise intervention
Procedure: Exercise and e-stim

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Exercise Intervention on Patients With Low Back Pain Due to Spondylolytic Spondylolisthesis.

Resource links provided by NLM:


Further study details as provided by University of Primorska:

Primary Outcome Measures:
  • Changes in measures of neuromuscular functions of the trunk [ Time Frame: Change from baseline values at 9 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: Change from baseline values at 9 weeks ] [ Designated as safety issue: No ]
  • Change in Posture [ Time Frame: Change from baseline values at 9 weeks ] [ Designated as safety issue: No ]
    Angular and linear posture measures in frontal and sagittal plane.


Estimated Enrollment: 48
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985776

Locations
Slovenia
Orthopaedic Hospital Valdoltra
Ankaran, Slovenia, 6280
University of Primorska, Science and Research Centre of Koper, Institute for Kinesiology Research
Koper, Slovenia, 6000
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
University Medical Centre Maribor
Maribor, Slovenia, 2000
Sponsors and Collaborators
University of Primorska
Investigators
Principal Investigator: Nejc Sarabon, PhD University of Primorska
  More Information

Additional Information:
No publications provided

Responsible Party: Nejc Sarabon, Dr. Nejc Sarabon, University of Primorska
ClinicalTrials.gov Identifier: NCT01985776     History of Changes
Other Study ID Numbers: L5-4293(B))
Study First Received: October 30, 2013
Last Updated: June 5, 2014
Health Authority: Slovenia: Ethics Committee

Keywords provided by University of Primorska:
Exercise
Electric Stimulation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Spondylolisthesis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014