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Failed Back Surgery SyndromeFBSSNCT04268602

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

A study testing local anesthetic injection in people with Failed Back Surgery Syndrome and Pain, Chronic, run by Haydarpasa Numune Training and Research Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Failed Back Surgery Syndrome, Pain, Chronic
What is being tested?
local anesthetic injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
1 Sep 2020to 1 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Needle phobia.
  • Wound, infection, allergy, burn-type lesions in the area to be injected
  • Malignity history

About this study

Official title: The Effect of Intradermal Local Anesthetic Injection on Pain and Functionality in Failed Back Surgery Syndrome

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.

Read the 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.

Being tested
local anesthetic injection
Keywords
FBSS, Failed Back Surgery Syndrome, Chronic Pain, local anesthetic, Intradermal Injection
Medical subject headings
Failed Back Surgery Syndrome, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • local anesthetic injectionOther

    Also called exercise and transcutaneous electrical nerve stimulation

    1% lidocaine

Study groups in NCT04268602
Study groupRoleWhat they receive
Intervention GroupExperimentalintradermal 1% lidocain injection 4 cc+ exercise and transcutaneous electrical nerve stimulation
Receives: Other: local anesthetic injection
Control GroupNo interventionexercise and transcutaneous electrical nerve stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline, immediately after the intervention, 1 month

  2. Change in OSWESTRY Disability Index scores

    Low Back Pain Disability Questionnaire. Minimum-maximum scores are 0-100. Higher scores mean worse outcome

    Measured: baseline, immediately after the intervention, 1 month

Secondary outcomes (3)
  1. Change in Hospital anxiety and depression scores

    anxiety and depression evaluation. Minimum-maximum scores are 0-21. Higher scores mean worse outcome

    Measured: baseline, immediately after the intervention, 1 month

  2. change in modified schober test measurement

    measurement to asses the mobility of lumbar vertebrae (cm)

    Measured: baseline, immediately after the intervention, 1 month

  3. change in Lateral hand to ground test measurement

    measurement to asses the mobility of lumbar vertebrae (cm)

    Measured: baseline, immediately after the intervention, 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2020
  2. Study start1 Sep 2020 (estimated)
  3. Primary completion1 Mar 2021 (estimated)
  4. Study completion1 Jul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized controlled study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04268602
Sponsor's protocol ID
HNEAH-KAEK2019/23-757
Acronym
FBSS
Status last verified
Jul 2020
First submitted
10 Jan 2020
Last updated
30 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing local anesthetic injection in people with Failed Back Surgery Syndrome and Pain, Chronic, run by Haydarpasa Numune Training and Research Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visual Analog Pain Scale scores (time frame: baseline, immediately after the intervention, 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.

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