Radiculopathy LumbarNCT04276519
Position-Induced Opening of the Intervertebral Foramen is Efficient to Treat an Acute Lumbosacral Radiculopathy Caused by Disc Herniation
A study testing Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen in people with Radiculopathy Lumbar and Disk Herniated Lumbar, run by General Hospital Sveti Duh.
Trial summary
Efficiency of the conservative mechanical lumbosacral nerve root decompression, as an adjunct to pharmacological treatment, in the case of acute lumbosacral radiculopathy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Radiculopathy Lumbar, Disk Herniated Lumbar, Low Back Pain
- What is being tested?
- Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 Jul 2016
- 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
- Age between 20 - 60
- Lumbar disc herniation proved by MRI
- Lumbosacral radiculopathy with symptoms of radicular pain, sensation dysfunction, and motor dysfunction proved by EMG diagnostics.
Who cannot join
- Age older than 60
- Degenerative lumbar stenosis
- Spondylolisthesis
- Vertebrae fractures
- Tumor metastasis
About this study
Official title: Randomized Controlled Trial to Investigate the Feasibility of a New Protocol for Treatment of Acute Low Back Pain and Sciatica From Lumbar Radiculopathy and Intervertebral Disc Herniation: Non-invasive Position-Induced Opening of the Intervertebral Foramen
Efficiency of the conservative mechanical lumbosacral nerve root decompression, as an adjunct to pharmacological treatment, in the case of acute lumbosacral radiculopathy.
Read the detailed description
Non-invasive Position-Induced Opening of the Intervertebral Foramen in sidelying position, as an adjunct to pharmacological treatment, was used in the case of acute lumbosacral radiculopathy.
20 examinees were split into two groups, 10 in the experimental and 10 in the control group. Experimental group was given positional opening of the intervert. foramen, together with pharmacological treatment - steroid antiinflammatory drug - dexamethasone, nonsteroid antiinflammatory drugs and pain killers while control group was given just the same pharmacological treatment and recommended rest.
Measured dependent variables were:
- Visual analogue pain scale (VAS) for the low back and radiculopathy, separately
- Straight leg raise in supine position - nerve mobility test
- EuroQol questionnaire - general health condition questionnaire
- Oswestry questionnaire - activities of daily living (ADL) specific questionnaire for low back pain and lumbosacral radiculopathies Inclusive criteria were: Age between 20 - 60, lumbar disc herniation recognized by the MRI, lumbosacral radiculopathy with symptoms such as radicular pain, sensation dysfunctions or motor dysfunctions, recognized by electromyography (EMG) diagnostics.
Exclusive criteria: age more than 60, degenerative lumbar stenosis, spondylolisthesis, vertebra fractures, tumours.
Conclusion: Physiotherapy with a positional, mechanical decompression of the compressed lumbosacral nerve root, as an adjunct to pharmacological treatment, is proved to be efficient with the lumbosacral radiculopathy. It is recommended to be applied since the first day of a patient admittance in the hospital if there is a position that can reduce the pain.
- Conditions
- Radiculopathy Lumbar, Disk Herniated Lumbar, Low Back Pain
- Being tested
- Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramenProcedure or surgery
Opening of the mechanical interface of the nerve root, neurodynamics
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Physiotherapeutic non-invasive position-induced opening of the intervertebral foramen and pharmacological treatment with steroid antiinflammatory drugs - dexamethasone, nonsteroid antiinflammatory drugs and pain killers - tramadol. Receives: Procedure: Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen |
| Control group | Active comparator | Pharmacological treatment with steroid antiinflammatory drugs - dexamethasone, nonsteroid antiinflammatory drugs and pain killers - tramadol. Receives: Procedure: Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain scale for low back pain (LBP) Visual analogue scale for radiculopathy
Pain descriptor
Measured: Change from baseline pain subjectively reported value by Visual Analogic Scale compared to same values at discharge (mean value 8 days)
Straight leg raise
Nerve mobility test for lower lumbar nerve roots and n. ischiadicus
Measured: Change from baseline nerve mobility objectively reported value by straight leg raise compared to same values at discharge (mean value 8 days)
EuroQol questionnaire
General health condition questionnaire
Measured: Change from baseline general health condition subjectively reported value by EuroQol questionnaire compared to same values at discharge (mean value 8 days)
Oswestry questionnaire
ADLs specific questionnaire for LBP and lumbosacral radiculopathy
Measured: Change from baseline activity of daily living specific questionnaire for low back pain and lumbosacral radiculopathy subjectively reported value by Oswestry questionnaire compared to same values at discharge (mean value 8 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Apr 2016
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiculopathy LumbarStudies 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
- Parallel groups
- Model description
- Experimental group and a control group. Prospective, randomised, clinical study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Sveti Duh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinisa Poznic, General Hospital Sveti Duh
- Investigators
- Anita Marcinko Budincevic, Study chair, Clinic of Neurology, Sveti Duh Clinical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276519
- Sponsor's protocol ID
- 01-2748
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Investigate the Feasibility of a New Protocol for Treatment of Acute Low Back Pain and Sciatica From Lumbar Radiculopathy and Intervertebral Disc Herniation: Non-invasive Position-Induced Opening of the Intervertebral Foramen
- ClinicalTrials.gov ID
- NCT04276519
- Acronym / sponsor ID
- 01-2748
- Conditions
- Radiculopathy Lumbar, Disk Herniated Lumbar, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- General Hospital Sveti DuhUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 19 Feb 2020 (actual)
- 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.
Efficiency of the conservative mechanical lumbosacral nerve root decompression, as an adjunct to pharmacological treatment, in the case of acute lumbosacral radiculopathy.
Detailed description
Non-invasive Position-Induced Opening of the Intervertebral Foramen in sidelying position, as an adjunct to pharmacological treatment, was used in the case of acute lumbosacral radiculopathy.
20 examinees were split into two groups, 10 in the experimental and 10 in the control group. Experimental group was given positional opening of the intervert. foramen, together with pharmacological treatment - steroid antiinflammatory drug - dexamethasone, nonsteroid antiinflammatory drugs and pain killers while control group was given just the same pharmacological treatment and recommended rest.
Measured dependent variables were:
- Visual analogue pain scale (VAS) for the low back and radiculopathy, separately
- Straight leg raise in supine position - nerve mobility test
- EuroQol questionnaire - general health condition questionnaire
- Oswestry questionnaire - activities of daily living (ADL) specific questionnaire for low back pain and lumbosacral radiculopathies Inclusive criteria were: Age between 20 - 60, lumbar disc herniation recognized by the MRI, lumbosacral radiculopathy with symptoms such as radicular pain, sensation dysfunctions or motor dysfunctions, recognized by electromyography (EMG) diagnostics.
Exclusive criteria: age more than 60, degenerative lumbar stenosis, spondylolisthesis, vertebra fractures, tumours.
Conclusion: Physiotherapy with a positional, mechanical decompression of the compressed lumbosacral nerve root, as an adjunct to pharmacological treatment, is proved to be efficient with the lumbosacral radiculopathy. It is recommended to be applied since the first day of a patient admittance in the hospital if there is a position that can reduce the pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental group and a control group. Prospective, randomised, clinical study.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramenPhysiotherapeutic non-invasive position-induced opening of the intervertebral foramen and pharmacological treatment with steroid antiinflammatory drugs - dexamethasone, nonsteroid antiinflammatory drugs and pain killers - tramadol. |
| Control group | Active comparator | Procedure: Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramenPharmacological treatment with steroid antiinflammatory drugs - dexamethasone, nonsteroid antiinflammatory drugs and pain killers - tramadol. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 20 - 60
- Lumbar disc herniation proved by MRI
- Lumbosacral radiculopathy with symptoms of radicular pain, sensation dysfunction, and motor dysfunction proved by EMG diagnostics.
Key exclusion criteria (5 listed)
- Age older than 60
- Degenerative lumbar stenosis
- Spondylolisthesis
- Vertebrae fractures
- Tumor metastasis
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 |
|---|---|---|
| Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramenOpening of the mechanical interface of the nerve root, neurodynamics | Procedure or surgery | Control group, Experimental |
Primary outcome
Visual analogue pain scale for low back pain (LBP) Visual analogue scale for radiculopathy
Time frame: Change from baseline pain subjectively reported value by Visual Analogic Scale compared to same values at discharge (mean value 8 days)
Pain descriptor
Straight leg raise
Time frame: Change from baseline nerve mobility objectively reported value by straight leg raise compared to same values at discharge (mean value 8 days)
Nerve mobility test for lower lumbar nerve roots and n. ischiadicus
EuroQol questionnaire
Time frame: Change from baseline general health condition subjectively reported value by EuroQol questionnaire compared to same values at discharge (mean value 8 days)
General health condition questionnaire
Oswestry questionnaire
Time frame: Change from baseline activity of daily living specific questionnaire for low back pain and lumbosacral radiculopathy subjectively reported value by Oswestry questionnaire compared to same values at discharge (mean value 8 days)
ADLs specific questionnaire for LBP and lumbosacral radiculopathy
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 19 Feb 2020.
- Holy Spirit Clinical HospitalLink provided by the sponsor.
- Clinical neurodynamicsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Radiculopathy Lumbar
Active, not recruiting
Comparative Effects of Kinetic Control Training and Neural Mobilization in Lumbar Radiculopathy
Lumbar Radiculopathy
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Recruiting
Comparative Effect Between Mulligan Leg Raise and Spinal Mobilization With Limb Movement in Lumbar Radiculopathy
Lumbar Radiculopathy
Not yet recruiting
Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial
Unilateral S1 Nerve Root Pain
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.
Anita Marcinko Budincevic study chair
Clinic of Neurology, Sveti Duh Clinical Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen in people with Radiculopathy Lumbar and Disk Herniated Lumbar, run by General Hospital Sveti Duh.
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 3 inclusion and 5 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 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual analogue pain scale for low back pain (LBP) Visual analogue scale for radiculopathy (time frame: Change from baseline pain subjectively reported value by Visual Analogic Scale compared to same values at discharge (mean value 8 days)). The study lists 4 primary outcomes in all. 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 19 Feb 2020.