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Comparison of Neural Mobilization Techniques to Standard Care Treatment in Patients With Lumbar Radiculitis

Primary Purpose

Radiculitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neural Mobilization
Standard Care
Sponsored by
Michalis Efstathiou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with low back pain and pain that radiates in the lower limb
  • Duration of symptoms > 6 weeks
  • Patients willing to be reassessed after 6 months
  • Patients willing to give written informed consent

Exclusion Criteria:

  • History of spinal surgery
  • History of surgery or injury in the lower limbs in the past 6 months
  • Signs and symptoms of central nervous system involvement
  • Nerve root blocks for the past 6 weeks
  • History of diabetes
  • History of polyneuropathies
  • History of vascular pathologies in the lower limbs
  • History of systemic pathologies
  • History of inflammatory arthropathies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Neural Mobilization Group

    Standard Care Group

    Arm Description

    Patients in this group will be treated with neural mobilization techniques.

    Patients in this group will be treated with standard care (ultrasound, exercise, TENS, massage)

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale (VAS) - Measure assessing change
    The VAS is a 100-point pain assessment scale ranging from 0 (no pain) to 100 (worst pain possible).

    Secondary Outcome Measures

    Roland Morris Disability Questionnaire (RMDQ) - Measure assessing change
    The questioner measures the level of patients' disability.
    Fear Avoidance and Beliefs Questionnaire (FABQ) - Measure assessing change
    The questioner evaluates fear-avoidance beliefs of patients with low back pain in the clinical setting.
    Handheld dynamometer - Measure assessing change
    Changes in Muscle Strength assessed with the handheld dynamometer

    Full Information

    First Posted
    October 19, 2016
    Last Updated
    May 2, 2017
    Sponsor
    Michalis Efstathiou
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02941133
    Brief Title
    Comparison of Neural Mobilization Techniques to Standard Care Treatment in Patients With Lumbar Radiculitis
    Official Title
    Effectiveness of Neural Mobilization Techniques Compared to Standard Care Treatment in Patients With Lumbar Radiculitis: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2017 (Anticipated)
    Primary Completion Date
    March 2020 (Anticipated)
    Study Completion Date
    March 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Michalis Efstathiou

    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
    The purpose of this study is to determine the effectiveness of neural mobilization techniques compared to standard care treatment in patients with lumbar radiculitis.
    Detailed Description
    Background: Radicular pain has been regarded as a distinct pain entity as its pathophysiology differs from that of somatic referred pain and nociceptive pain. Radicular lumbar pain describes sensitized nerve roots of the lumbar spine or peripheral nerve trunks that are capable of producing pain (usually below the knee) and/or other symptoms in the absence of true nerve tissue damage. This type of pain is evoked by ectopic discharges stemming from lumbar dorsal roots or their ganglions. The most common causes for this type of pain is the inflammatory environment that is produced by substances contained in the herniated material of injured lumbar intervertebral discs. It has been suggested that patients presenting with functional (e.g. mechanosensitivity) but not structural nerve root problems, can be identified through screening and further classified as a discrete group of patients that benefit from specific neural mobilization techniques. Neural mobilization techniques have gained considerable amount of attention amongst therapists and researchers for the assessment and treatment of painful conditions that occasionally involve a neural element in their pathophysiology such as lumbar radicular pain. Studies exploring the effect of neural mobilization techniques on patients with lumbar radicular pain have generally shown good results but they are lacking in adequate sample size and methodological quality. The aim of this study is to compare the effectiveness of neural mobilization techniques to standard care physiotherapy treatment (ultrasound, general exercises, massage therapy, transcutaneous electrical nerve stimulation) in patients with lumbar radiculitis. Participants: Patients with low back pain that radiates to the lower limb. Patients that satisfy the inclusion criteria will be screened and classified by another researcher into the distinct group of lumbar radiculitis. Another researcher will take baseline measurements and all patients of this sub-group will be randomly assigned to receive either neural mobilization or standard care physiotherapy treatment. Both groups will receive a total of 10 treatments twice per week for 5 weeks. Patients will be assessed using specific outcome measures prior to treatment (baseline), at 5 weeks (post treatment) and 6 months after treatment. Statistical analysis: Data will be analysed with the Statistical Package for the Social Sciences (SPSS), version 22. Intension to treat analysis will be applied. A two-way mixed-model analysis of variance will be used for outcome measures, with treatment groups (neural mobilization or standard care treatment) as the between-subject variable and time (baseline, 1 month follow up, six months follow up) as the within-subject variable. Comparison of baseline demographic characteristics will be analysed using the t-tests for continuous variables and the chi square tests for categorical variables.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Radiculitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Neural Mobilization Group
    Arm Type
    Experimental
    Arm Description
    Patients in this group will be treated with neural mobilization techniques.
    Arm Title
    Standard Care Group
    Arm Type
    Experimental
    Arm Description
    Patients in this group will be treated with standard care (ultrasound, exercise, TENS, massage)
    Intervention Type
    Other
    Intervention Name(s)
    Neural Mobilization
    Intervention Description
    Neural mobilization techniques aimed at the lumbar root that is affected
    Intervention Type
    Other
    Intervention Name(s)
    Standard Care
    Intervention Description
    Ultrasound - Transcutaneous electrical nerve stimulation (TENS) - Massage therapy - Strengthening exercises
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale (VAS) - Measure assessing change
    Description
    The VAS is a 100-point pain assessment scale ranging from 0 (no pain) to 100 (worst pain possible).
    Time Frame
    Change from baseline after 5 weeks and at 6 months
    Secondary Outcome Measure Information:
    Title
    Roland Morris Disability Questionnaire (RMDQ) - Measure assessing change
    Description
    The questioner measures the level of patients' disability.
    Time Frame
    Change from baseline after 5 weeks and at 6 months
    Title
    Fear Avoidance and Beliefs Questionnaire (FABQ) - Measure assessing change
    Description
    The questioner evaluates fear-avoidance beliefs of patients with low back pain in the clinical setting.
    Time Frame
    Change from baseline after 5 weeks and at 6 months
    Title
    Handheld dynamometer - Measure assessing change
    Description
    Changes in Muscle Strength assessed with the handheld dynamometer
    Time Frame
    Change from baseline after 5 weeks and at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with low back pain and pain that radiates in the lower limb Duration of symptoms > 6 weeks Patients willing to be reassessed after 6 months Patients willing to give written informed consent Exclusion Criteria: History of spinal surgery History of surgery or injury in the lower limbs in the past 6 months Signs and symptoms of central nervous system involvement Nerve root blocks for the past 6 weeks History of diabetes History of polyneuropathies History of vascular pathologies in the lower limbs History of systemic pathologies History of inflammatory arthropathies
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michalis Efstathiou, MSc
    Phone
    +35799931840
    Email
    efstathiou.m@unic.ac.cy
    First Name & Middle Initial & Last Name or Official Title & Degree
    Manos Stefanakis, PhD
    Phone
    +35796418779
    Email
    stefanakis.m@unic.ac.cy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michalis Efstathiou, MSc
    Organizational Affiliation
    University of Nicosia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    21116662
    Citation
    Schafer A, Hall T, Muller G, Briffa K. Outcomes differ between subgroups of patients with low back and leg pain following neural manual therapy: a prospective cohort study. Eur Spine J. 2011 Mar;20(3):482-90. doi: 10.1007/s00586-010-1632-2. Epub 2010 Dec 1.
    Results Reference
    result

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    Comparison of Neural Mobilization Techniques to Standard Care Treatment in Patients With Lumbar Radiculitis

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