NCT01985776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

October 30, 2013

Last Update Submit

February 7, 2018

Conditions

Low Back PainSpondylolisthesis

Keywords

ExerciseElectric Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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

    Change from baseline values at 9 weeks

Secondary Outcomes (2)

  • Changes in Oswestry questionnaire score

    Change from baseline values at 9 weeks

  • Change in Posture parameters

    Change from baseline values at 9 weeks

Study Arms (4)

Exercise intervention

ACTIVE COMPARATOR

Patients will functional stabilisation exercise for the trunk.

Procedure: Exercise intervention

Exercise and e-stim

ACTIVE COMPARATOR

Patients will receive exercise intervention and electrical stimulation simultaneously.

Procedure: Exercise and e-stim

Patients control

NO INTERVENTION

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

Healthy control

NO INTERVENTION

Healthy asymptomatic participants who will not receive any treatment.

Interventions

Exercise interventionPROCEDURE

Functional stabilisation exercise for the trunk.

Exercise intervention
Exercise and e-stimPROCEDURE

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

Exercise and e-stim

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Orthopaedic Hospital Valdoltra

Ankaran, 6280, Slovenia

Location

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

Koper, 6000, Slovenia

Location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

University Medical Centre Maribor

Maribor, 2000, Slovenia

Location

MeSH Terms

Conditions

Low Back PainSpondylolisthesisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nejc Sarabon, PhD

    University of Primorska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr. Sc.

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 15, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

SL(4)