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

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ClinicalTrials.gov Identifier: NCT04268602
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Duygu Geler Külcü, Haydarpasa Numune Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Pain, Chronic Other: local anesthetic injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled study
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effect of Intradermal Local Anesthetic Injection on Pain and Functionality in Failed Back Surgery Syndrome
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : July 1, 2021

Arm Intervention/treatment
Experimental: Intervention Group
intradermal 1% lidocain injection 4 cc+ exercise and transcutaneous electrical nerve stimulation
Other: local anesthetic injection
1% lidocaine
Other Name: exercise and transcutaneous electrical nerve stimulation

No Intervention: Control Group
exercise and transcutaneous electrical nerve stimulation



Primary Outcome Measures :
  1. Change in Visual Analog Pain Scale scores [ Time Frame: baseline, immediately after the intervention, 1 month ]
    Visual analog scale for measurement of pain. Minimum-maximum scores are 0-10. Higher scores mean worse outcome

  2. Change in OSWESTRY Disability Index scores [ Time Frame: baseline, immediately after the intervention, 1 month ]
    Low Back Pain Disability Questionnaire. Minimum-maximum scores are 0-100. Higher scores mean worse outcome


Secondary Outcome Measures :
  1. Change in Hospital anxiety and depression scores [ Time Frame: baseline, immediately after the intervention, 1 month ]
    anxiety and depression evaluation. Minimum-maximum scores are 0-21. Higher scores mean worse outcome

  2. change in modified schober test measurement [ Time Frame: baseline, immediately after the intervention, 1 month ]
    measurement to asses the mobility of lumbar vertebrae (cm)

  3. change in Lateral hand to ground test measurement [ Time Frame: baseline, immediately after the intervention, 1 month ]
    measurement to asses the mobility of lumbar vertebrae (cm)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Duygu Geler Külcü, Clinical Professor Dr, Head of Physical Medicine and Rehabilitation Department, Haydarpasa Numune Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04268602    
Other Study ID Numbers: HNEAH-KAEK2019/23-757
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Duygu Geler Külcü, Haydarpasa Numune Training and Research Hospital:
FBSS
Failed Back Surgery Syndrome
Chronic Pain
local anesthetic
Intradermal Injection
Additional relevant MeSH terms:
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Syndrome
Chronic Pain
Failed Back Surgery Syndrome
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Postoperative Complications
Back Pain
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents