The Effect of Central Sensitization in Radicular Pain in Patients With Failed Low Back Surgery Syndrome

NCT06508918 | Completed

• 1 other identifier: 03.03.2023.375
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

The Effect of Central Sensitization in Radicular Pain in Patients with Failed Low Back Surgery Syndrome on Treatment Success of Ultrasound-Guided Caudal Epidural Steroid Injection

Conditions

Herniated Disc; Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale /NRS

  At least 50 percent improvement in Numeric Rating Scale (NRS more than fifty percent reduction indicates greater improvement. The nrs score is scored from 0 to 100. Higher scores are associated with more pain.)

  3rd months

Secondary Outcomes (5)

• Improvements in Douleur Neuropathique 4 Questions

  3rd month

• Improvements in Beck's Depression Inventory

  3rd month

• Improvements in Oswestry Disability Index

  3rd month

• Improvements in Central Sensitization inventory

  3rd month

• Improvements in Pressure Pain Thresold values

  3rd month

Study Arms (2)

group 1 (with central sensitization)

Group: group 1 (with central sensitization) 8 mg betamethasone, 3 cc bupivacaine, 5 cc serum will be injected in the neck, and caudal force pressure, pressure pain thresholds will be evaluated with a manual algometer, accompanied by ultrasonography. Group: group 2 (without central sensitization) 8 mg betamethasone, 3 cc bupivacaine, 5 cc serum will be injected in the neck, and caudal force pressure, pressure pain thresholds will be evaluated with a manual algometer, accompanied by ultrasonography.

Drug: Betametasona

group 2 (without central sensitization)

Group: group 1 (with central sensitization) 8 mg betamethasone, 3 cc bupivacaine, 5 cc serum will be injected in the neck, and caudal force pressure, pressure pain thresholds will be evaluated with a manual algometer, accompanied by ultrasonography. Group: group 2 (without central sensitization) 8 mg betamethasone, 3 cc bupivacaine, 5 cc serum will be injected in the neck, and caudal force pressure, pressure pain thresholds will be evaluated with a manual algometer, accompanied by ultrasonography.

Drug: Betametasona

Interventions

Betametasona DRUG

pressure pain threshold values of the most painful area will be recorded with a manual algometer

Also known as: baseline brand algometer

group 1 (with central sensitization); group 2 (without central sensitization)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients between the ages of 18-75 who have had unsuccessful back surgery and who have had low back and leg pain for at least 6 months that started in the same region before the surgery

You may qualify if:

• years old
• Meeting the diagnostic criteria for failed back surgery syndrome
• Radicular pain that begins any time after surgery and lasts for at least 6 months
• Epidural fibrosis and/or disc herniation at the L5 and/or S1 vertebral level on contrast-enhanced MR imaging
• Nrs equal to or greater than 4
• Conservative methods are ineffective
• Volunteer

You may not qualify if:

• Acute or chronic uncontrolled medical illness
• Lumbar localization pathologies
• Isolated axial low back pain
• History of lumbar stabilization or non-microdiscectomy lumbar surgery
• History of adverse statements against local anesthesia or steroids being pregnant or breastfeeding
• Stories on the injectables to be administered bleeding diet
• Not wanting to participate in the research

Sponsors & Collaborators

• Marmara University: lead

Study Sites (2)

Mamara Üniversitesi Tıp Fakültesi

Istanbul, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Failed Back Surgery Syndrome

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Savaş Şencan

  Marmara Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: July 18, 2024
• Study Start: April 15, 2023
• Primary Completion: July 15, 2023
• Study Completion: May 15, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

TU (2)