Position-Induced Opening of the Intervertebral Foramen is Efficient to Treat an Acute Lumbosacral Radiculopathy Caused by Disc Herniation
Primary Purpose
Radiculopathy Lumbar, Disk Herniated Lumbar, Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen
Sponsored by
About this trial
This is an interventional treatment trial for Radiculopathy Lumbar
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Age older than 60
- Degenerative lumbar stenosis
- Spondylolisthesis
- Vertebrae fractures
- Tumor metastasis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control group
Arm Description
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.
Pharmacological treatment with steroid antiinflammatory drugs - dexamethasone, nonsteroid antiinflammatory drugs and pain killers - tramadol.
Outcomes
Primary Outcome Measures
Visual analogue pain scale for low back pain (LBP) Visual analogue scale for radiculopathy
Pain descriptor
Straight leg raise
Nerve mobility test for lower lumbar nerve roots and n. ischiadicus
EuroQol questionnaire
General health condition questionnaire
Oswestry questionnaire
ADLs specific questionnaire for LBP and lumbosacral radiculopathy
Secondary Outcome Measures
Full Information
NCT ID
NCT04276519
First Posted
February 10, 2020
Last Updated
February 17, 2020
Sponsor
General Hospital Sveti Duh
1. Study Identification
Unique Protocol Identification Number
NCT04276519
Brief Title
Position-Induced Opening of the Intervertebral Foramen is Efficient to Treat an Acute Lumbosacral Radiculopathy Caused by Disc Herniation
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
July 1, 2016 (Actual)
Study Completion Date
July 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital Sveti Duh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy Lumbar, Disk Herniated Lumbar, Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group and a control group. Prospective, randomised, clinical study.
Masking
Participant
Masking Description
Participants didn't know in which group they were allocated.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Pharmacological treatment with steroid antiinflammatory drugs - dexamethasone, nonsteroid antiinflammatory drugs and pain killers - tramadol.
Intervention Type
Procedure
Intervention Name(s)
Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen
Intervention Description
Opening of the mechanical interface of the nerve root, neurodynamics
Primary Outcome Measure Information:
Title
Visual analogue pain scale for low back pain (LBP) Visual analogue scale for radiculopathy
Description
Pain descriptor
Time Frame
Change from baseline pain subjectively reported value by Visual Analogic Scale compared to same values at discharge (mean value 8 days)
Title
Straight leg raise
Description
Nerve mobility test for lower lumbar nerve roots and n. ischiadicus
Time Frame
Change from baseline nerve mobility objectively reported value by straight leg raise compared to same values at discharge (mean value 8 days)
Title
EuroQol questionnaire
Description
General health condition 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)
Title
Oswestry questionnaire
Description
ADLs specific questionnaire for LBP and lumbosacral radiculopathy
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Age older than 60
Degenerative lumbar stenosis
Spondylolisthesis
Vertebrae fractures
Tumor metastasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Marcinko Budincevic
Organizational Affiliation
Clinic of Neurology, Sveti Duh Clinical Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.kbsd.hr/
Description
Holy Spirit Clinical Hospital
URL
http://www.neurodynamicsolutions.com/
Description
Clinical neurodynamics
Learn more about this trial
Position-Induced Opening of the Intervertebral Foramen is Efficient to Treat an Acute Lumbosacral Radiculopathy Caused by Disc Herniation
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