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
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
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
NCT ID
NCT04268602
First Posted
January 10, 2020
Last Updated
July 29, 2020
Sponsor
Haydarpasa Numune Training and Research Hospital
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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