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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
General Hospital Sveti Duh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculopathy Lumbar

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 20 - 60
  2. Lumbar disc herniation proved by MRI
  3. Lumbosacral radiculopathy with symptoms of radicular pain, sensation dysfunction, and motor dysfunction proved by EMG diagnostics.

Exclusion Criteria:

  1. Age older than 60
  2. Degenerative lumbar stenosis
  3. Spondylolisthesis
  4. Vertebrae fractures
  5. 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

    First Posted
    February 10, 2020
    Last Updated
    February 17, 2020
    Sponsor
    General Hospital Sveti Duh
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    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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