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The Effect of Intradermal Local Anesthetic Injection in FBSS (Failed Back Surgery Syndrome) (FBSS)

Primary Purpose

Failed Back Surgery Syndrome, Pain, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
local anesthetic injection
Sponsored by
Haydarpasa Numune Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Failed Back Surgery Syndrome focused on measuring FBSS, Failed Back Surgery Syndrome, Chronic Pain, local anesthetic, Intradermal Injection

Eligibility Criteria

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

Inclusion Criteria:

  • Having been diagnosed with failed back surgery syndrome
  • 18-75 years of age
  • visual analogue pain score> 4 to be

Exclusion Criteria:

  • Mental problems
  • Having a disease affecting the central nervous system or peripheral nervous system
  • Fixation operation to the lumbar region
  • Physical therapy in the lumbar region within the last 3 months
  • Injection from the lumbar region in the last 3 months
  • Lidocaine allergy
  • Needle phobia.
  • Wound, infection, allergy, burn-type lesions in the area to be injected
  • Malignity history

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    intradermal 1% lidocain injection 4 cc+ exercise and transcutaneous electrical nerve stimulation

    exercise and transcutaneous electrical nerve stimulation

    Outcomes

    Primary Outcome Measures

    Change in Visual Analog Pain Scale scores
    Visual analog scale for measurement of pain. Minimum-maximum scores are 0-10. Higher scores mean worse outcome
    Change in OSWESTRY Disability Index scores
    Low Back Pain Disability Questionnaire. Minimum-maximum scores are 0-100. Higher scores mean worse outcome

    Secondary Outcome Measures

    Change in Hospital anxiety and depression scores
    anxiety and depression evaluation. Minimum-maximum scores are 0-21. Higher scores mean worse outcome
    change in modified schober test measurement
    measurement to asses the mobility of lumbar vertebrae (cm)
    change in Lateral hand to ground test measurement
    measurement to asses the mobility of lumbar vertebrae (cm)

    Full Information

    First Posted
    January 10, 2020
    Last Updated
    July 29, 2020
    Sponsor
    Haydarpasa Numune Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04268602
    Brief Title
    The Effect of Intradermal Local Anesthetic Injection in FBSS (Failed Back Surgery Syndrome)
    Acronym
    FBSS
    Official Title
    The Effect of Intradermal Local Anesthetic Injection on Pain and Functionality in Failed Back Surgery Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2021 (Anticipated)
    Study Completion Date
    July 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Haydarpasa Numune Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Failed Back Surgery Syndrome is described as chronic pain in the low back and/or legs after a spinal procedure. It is estimated that %10 - 40 of the patients who had spinal surgery will have Failed Back Surgery Syndrome. The aim of this study is to research whether intradermal injection of the local anesthetic on the operation scar area and the area in which pain referred to in patients with Failed Back Surgery Syndrome has effects on pain and functionality or not.
    Detailed Description
    The prevalence of low back pain is around 60% - 80% and its the 5th most common disease to seek medical help. 80% of patients who have an acute onset of low back pain whether treated or not relieved on symptoms, while unfortunately 10% of patients' low back pain will worsen end eventually progress to chronic low back pain. With the increase on the number of different techniques on spinal surgery, and an increase in the number of patients who had risk factors undergone spinal surgery caused an increase in the number of patients who had new complaints after surgery. The term Failed Back Surgery Syndrome describes new complaints or not enough ease on the complaints of a patient who had spinal surgery. Due to the variation of the criteria of assessment, it is noted that around 10% -40% of the patients who had spinal surgery will have Failed Back Surgery Syndrome. Failed Back Surgery Syndrome is commonly described as pain in low back and/or legs with difficulty in daily activities. Pain might be radicular or localized to the low back, it might be mechanic or neuropathic in nature. Some of the pathologies that cause Failed Back Surgery Syndrome are loss of height on the disc, arthrosis, spinal stenosis caused by the hypertrophy of the facet joints, recurrent disc herniation, arachnoiditis, central stenosis, epidural fibrosis, instability, pseudoarthrosis, and discitis. Rehabilitation is one of the vital parts of the treatment of Failed Back Surgery Syndrome. After a detailed patient history and a complete physical examination, clinicians should create a rehabilitation program that aims improvements on pain, functionality, quality of life and activities of daily living and is tailored for the patient. It is shown that patients who undergo rehabilitation programs had improvements in physical functionality, posture, and difficulties with walking. Other conservative treatments include cognitive behavioral therapy and noninvasive injection techniques. Literature shows that multifidus muscle is damaged and atrophied in the patients who had spinal surgery. Also, there is a correlation between functional impairment and atrophy. Usually, the muscles that control flexion and extension of the low back are weak in patients who have low back pain. Extensor muscles, especially the erector spinae muscle group are the posterior stabilisers of the vertebral colon. Loss of endurance and weakness of these muscles and low back pain have a correlation and strengthening these muscles will result in an improvement in low back pain. Injections of local anesthetics on chronic pain syndromes are being used successfully for a long time. There are some examples of successful interventions on pelvic pain, myofascial pain syndrome and nonspecific chronic low back pain in the literature. While surgery is the first line of treatment in cases where the cause is the compromise of the neural structures or spinal instability, the pain will increase with recurrent surgery in other causes. Ligaments of the intervertebral disc complex which are innervated by the nociceptive neurons, facet joints, and paravertebral muscles are thought to be the reason for pain in Failed Back Surgery Syndrome. In a systemic review that took place in 2015; the superiority of injections done with saline, a mixture of steroids and local anesthetics and steroids alone for facet joints and epidural injection procedure was investigated. Investigators demonstrated that injection with local anesthetics alone was effective in treatment. Another systemic review in 2019 showed that injection of local anesthetics was effective and was superior to botulinum toxin A in the treatment of myofascial pain. Intradermal injection of a drug is related to longer pharmacological effects compared to intramuscular and subcutaneous injections. Lidocaine antinociceptive, analgesic, anti-bacterial, anti-fungal, anti-viral, wound healing, releasing of endogen opioid effects were demonstrated. In the light of all the information above, the investigators wanted to research whether intradermal injection of the local anesthetic in patients with Failed Back Surgery Syndrome has effects on pain and functionality or not.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Failed Back Surgery Syndrome, Pain, Chronic
    Keywords
    FBSS, Failed Back Surgery Syndrome, Chronic Pain, local anesthetic, Intradermal Injection

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized controlled study
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    intradermal 1% lidocain injection 4 cc+ exercise and transcutaneous electrical nerve stimulation
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    exercise and transcutaneous electrical nerve stimulation
    Intervention Type
    Other
    Intervention Name(s)
    local anesthetic injection
    Other Intervention Name(s)
    exercise and transcutaneous electrical nerve stimulation
    Intervention Description
    1% lidocaine
    Primary Outcome Measure Information:
    Title
    Change in Visual Analog Pain Scale scores
    Description
    Visual analog scale for measurement of pain. Minimum-maximum scores are 0-10. Higher scores mean worse outcome
    Time Frame
    baseline, immediately after the intervention, 1 month
    Title
    Change in OSWESTRY Disability Index scores
    Description
    Low Back Pain Disability Questionnaire. Minimum-maximum scores are 0-100. Higher scores mean worse outcome
    Time Frame
    baseline, immediately after the intervention, 1 month
    Secondary Outcome Measure Information:
    Title
    Change in Hospital anxiety and depression scores
    Description
    anxiety and depression evaluation. Minimum-maximum scores are 0-21. Higher scores mean worse outcome
    Time Frame
    baseline, immediately after the intervention, 1 month
    Title
    change in modified schober test measurement
    Description
    measurement to asses the mobility of lumbar vertebrae (cm)
    Time Frame
    baseline, immediately after the intervention, 1 month
    Title
    change in Lateral hand to ground test measurement
    Description
    measurement to asses the mobility of lumbar vertebrae (cm)
    Time Frame
    baseline, immediately after the intervention, 1 month

    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: Having been diagnosed with failed back surgery syndrome 18-75 years of age visual analogue pain score> 4 to be Exclusion Criteria: Mental problems Having a disease affecting the central nervous system or peripheral nervous system Fixation operation to the lumbar region Physical therapy in the lumbar region within the last 3 months Injection from the lumbar region in the last 3 months Lidocaine allergy Needle phobia. Wound, infection, allergy, burn-type lesions in the area to be injected Malignity history

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effect of Intradermal Local Anesthetic Injection in FBSS (Failed Back Surgery Syndrome)

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