Low Back PainEXER-SPO-TNCNCT01985776
Effects of Exercise Intervention in Patients With Spondylolisthesis Related LBP
A study testing Exercise intervention and Exercise and e-stim in people with Low Back Pain and Spondylolisthesis, run by University of Primorska at 4 sites in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Low Back Pain, Spondylolisthesis
- What is being tested?
- Exercise intervention and Exercise and e-stim
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesSlovenia
- Study dates
- Jun 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Slovenia4 sites
Orthopaedic Hospital Valdoltra
Ankaran, 6280
University of Primorska, Science and Research Centre of Koper, Institute for Kinesiology Research
Koper, 6000
University Medical Centre Ljubljana
Ljubljana, 1000
University Medical Centre Maribor
Maribor, 2000
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain, Spondylolisthesis
- Being tested
- Exercise intervention, Exercise and e-stim
- Keywords
- Exercise, Electric Stimulation
- Medical subject headings
- Low Back Pain, Spondylolisthesis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionProcedure or surgery
Functional stabilisation exercise for the trunk.
Exercise and e-stimProcedure or surgery
Functional stabilisation exercise for the trunk and electrical stimulation at the same time.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Active comparator | Patients will functional stabilisation exercise for the trunk. Receives: Procedure: Exercise intervention |
| Exercise and e-stim | Active comparator | Patients will receive exercise intervention and electrical stimulation simultaneously. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline values at 9 weeks
Secondary outcomes (2)
Changes in Oswestry questionnaire score
Oswestry Low Back Pain Questionnaire commolny used by clinicians and researchers to quantify disability for low back pain.
Measured: Change from baseline values at 9 weeks
Change in Posture parameters
Angular and linear posture measures in frontal and sagittal plane.
Measured: Change from baseline values at 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- S2P, Science to Practice, Ltd.
- Responsible party
- Principal investigator, Nejc Sarabon, University of Primorska
- Investigators
- Nejc Sarabon, PhD, Principal investigator, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985776
- Sponsor's protocol ID
- UP-FVZ-ExerciseSpondylolisth
- Acronym
- EXER-SPO-TNC
- Status last verified
- Feb 2018
- First submitted
- 30 Oct 2013
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Intervention in Patients With Low Back Pain Due to Spondylolytic Spondylolisthesis
- ClinicalTrials.gov ID
- NCT01985776
- Acronym / sponsor ID
- EXER-SPO-TNC / UP-FVZ-ExerciseSpondylolisth
- Conditions
- Low Back Pain, Spondylolisthesis
- Keywords
- Exercise, Electric Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- S2P, Science to Practice, Ltd.
- Study start
- Jun 2013 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Active comparator | Procedure: Exercise interventionPatients will functional stabilisation exercise for the trunk. |
| Exercise and e-stim | Active comparator | Procedure: Exercise and e-stimPatients will receive exercise intervention and electrical stimulation simultaneously. |
| 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionFunctional stabilisation exercise for the trunk. | Procedure or surgery | Exercise intervention |
| Exercise and e-stimFunctional stabilisation exercise for the trunk and electrical stimulation at the same time. | Procedure or surgery | Exercise and e-stim |
Primary outcome
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
2 secondary outcomes
Changes in Oswestry questionnaire score
Time frame: Change from baseline values at 9 weeks
Change in Posture parameters
Time frame: Change from baseline values at 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nejc Sarabon, PhD principal investigator
University of Primorska
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention and Exercise and e-stim in people with Low Back Pain and Spondylolisthesis, run by University of Primorska at 4 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in measures of neuromuscular functions of the trunk (time frame: Change from baseline values at 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.