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Ultrasound and Peripheral Nerve Stimulator Guided Femoral Nerve Block

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Femoral nerve block with phenol
Sponsored by
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring nerve block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Traumatic etiology
  • Duration of spinal cord injury more than twelve months
  • Spasticity of hip flexor and/or knee extensor muscle
  • Use of any oral medications to reduce spasticity at stable doses for at least one month before first assessment
  • The patients have to accept to continue same dose until end of the last assessment
  • Medical clearance to participate

Exclusion Criteria:

  • Having established contracture of the knee/hip joint
  • Aged over 65 years
  • History of surgery for knee/hip disorders
  • Non-traumatic etiology

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    femoral nerve block

    Arm Description

    Outcomes

    Primary Outcome Measures

    Modified Ashworth Scale
    Scale measures muscle tone (spasticity). (min-max:0-4).Higher values represent a worse outcome.

    Secondary Outcome Measures

    Functional independence measure
    Scale measures level of independence on activities of daily life (min-max: 0-126) points).Motor subscale of FIM measure is used in this study (min-max:0-91). Higher values represent a better outcome.

    Full Information

    First Posted
    February 27, 2018
    Last Updated
    March 11, 2018
    Sponsor
    Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03468439
    Brief Title
    Ultrasound and Peripheral Nerve Stimulator Guided Femoral Nerve Block
    Official Title
    Short Term Effect of Ultrasound and Peripheral Nerve Stimulator Guided Femoral Nerve Block With Phenol on Outcomes in People With Traumatic Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    A pre-post descriptive study was performed to examine the immediate effects of ultrasound (US) guided femoral nerve block with phenol (UGFNBwP) in managing lower limb spasticity of individuals with traumatic spinal cord injury (SCI).
    Detailed Description
    Study Design: A pre-post descriptive study was performed. Objectives: To examine the immediate effects of ultrasound (US) guided femoral nerve block with phenol (UGFNBwP) in managing lower limb spasticity of individuals with traumatic spinal cord injury (SCI). Setting: Ankara, Turkey Methods: Nineteen patients with traumatic SCI presenting with lower extremity spasticity were treated with UGFNBwP. Modified Ashworth Scale (MAS) of hip flexion and knee extension, functional independence measure (FIM) motor subscale, difficulty of catheterization (DoC), hygiene score (HS), spasm frequency (SF), sleep quality (SQ) and patient satisfaction (PS) were measured in all patients prior to treatment, at first week and second month.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries
    Keywords
    nerve block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    femoral nerve block
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Femoral nerve block with phenol
    Primary Outcome Measure Information:
    Title
    Modified Ashworth Scale
    Description
    Scale measures muscle tone (spasticity). (min-max:0-4).Higher values represent a worse outcome.
    Time Frame
    up to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Functional independence measure
    Description
    Scale measures level of independence on activities of daily life (min-max: 0-126) points).Motor subscale of FIM measure is used in this study (min-max:0-91). Higher values represent a better outcome.
    Time Frame
    up to 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Traumatic etiology Duration of spinal cord injury more than twelve months Spasticity of hip flexor and/or knee extensor muscle Use of any oral medications to reduce spasticity at stable doses for at least one month before first assessment The patients have to accept to continue same dose until end of the last assessment Medical clearance to participate Exclusion Criteria: Having established contracture of the knee/hip joint Aged over 65 years History of surgery for knee/hip disorders Non-traumatic etiology

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Ultrasound and Peripheral Nerve Stimulator Guided Femoral Nerve Block

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