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

NCT04268602 | Unknown

• 1 other identifier: HNEAH-KAEK2019/23-757
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Failed Back Surgery Syndrome; Pain, Chronic

Keywords

FBSS; Failed Back Surgery Syndrome; Chronic Pain; local anesthetic; Intradermal Injection

Outcome Measures

Primary Outcomes (2)

• 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

  baseline, immediately after the intervention, 1 month

• Change in OSWESTRY Disability Index scores

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

  baseline, immediately after the intervention, 1 month

Secondary Outcomes (3)

• Change in Hospital anxiety and depression scores

  baseline, immediately after the intervention, 1 month

• change in modified schober test measurement

  baseline, immediately after the intervention, 1 month

• change in Lateral hand to ground test measurement

  baseline, immediately after the intervention, 1 month

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: local anesthetic injection

Control Group

NO INTERVENTION

exercise and transcutaneous electrical nerve stimulation

Interventions

local anesthetic injection OTHER

1% lidocaine

Also known as: exercise and transcutaneous electrical nerve stimulation

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Chronic Pain

Interventions

Anesthetics, Local; Exercise; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor Dr, Head of Physical Medicine and Rehabilitation Department

Model Details: randomized controlled study

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: February 13, 2020
• Study Start: September 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share