EuroPainClinics® Study I (Prospective Trial) (EPCSI)

EuroPainClinics® Study I (Prospective Randomized Double Blinded Trial)

In this prospective multi-centre double-blind trial the effect of the X-ray examinations controlled periradicular therapy should be examined in (approximately 300) adult patients with low back pain pain caused by foraminal stenosis radiculopathy or spinal stenosis.

A periradicular therapy (PRT) is a special radiological, low-risk therapy for chronic back pain caused by wear and tear of the cervical, thoracic, and lumbar spine or a herniated disc or disc bulge. Partially pain might also radiate to the hips or extremities and cause radicular symptoms.

Study Overview

• Status: Terminated
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Other: periradicular therapy (PRT)

Detailed Description

Controlled periradicular therapy (PRT) is a microinvasive interventional pain release procedure. Advantage of targeted pain therapy is exact administration of effective drugs to the nerve root in the area of the thoracic, lumbar or sacral spines. It is used like as effective treatment in the patients with radicular pain caused by foraminal stenosis radiculopathy or spinal stenosis.

Spinal stenosis is the narrowing of spaces in the spine which causes pressure on the spinal cord and nerves. Discogenic radicular irritation syndrome is usually caused by protrusion of intervertebral disc or prolapsed disc. The most common is lumbar and sacral radiculopathy which could by exactly verified by CT or magnetic resonance imaging. The biggest profit with the best response on this therapy has patients who are resistant for physiotherapy or per oral medicament therapy.

Intervertebral space verification is provided by X-ray examination imaging. Than in this place is Tuohy needle inserted. Position of Tuohy needle is verified by application of low dose of contrast. When the right position of needle is secured than effective drugs are administered: local anesthetic - Bupivacaine 0,25% (1-2ml) together with corticosteroid injection -Depo-Medrol (40mg). PRT involves several medicable effects: anaesthetic - positive effect on pain transmission in nerve fibers, antichemical - limitation of chemical products from sequestered discs, Anti-edematous - reduction of root nerve oedema, antiphlogistic - inhibition of phospholipase A2, antifibrotic - reduction of scar production.

Trial will compare groups of patients after fulfilment inclusion criteria's who will undergo microinvasive interventional pain release procedure - PRT.

The first group of patients will undergo PRT procedure in the intervertebral space responsible for skin dermatome were the pain is radiating.

Second group of patients will undergo double PRT procedure in the intervertebral space responsible for skin dermatome where the pain is radiating and also in the intervertebral space above where usually is disc lesion responsible for origin of pain localized. After first visit in ambulance patients will be about study informed. After agreement patient will be in to the study involved. Specific unique nine digits number will be assigned to each patient. Then patients will be randomized in to groups by special evaluated software created especially for this study. Patients will agree that about type of PRT (one level or two levels) will be informed until the end of the study. This way will be patients blinded.

Second examination will be provided after 6 months. Patients will be in the beginning introduced to doctor only by their unique number. Doctor will be blinded and he will not dispose with information about microinvasive procedure and will examine patient. Data which will be collected: (Visual analogue scale, pain radiating dermatome, global pain scale, changes in analgesics drugs consumption). All acquired information will be noted in to the special anonymous protocol. Also patients will anonymously fulfill Oswestry Low Back Disability Questionnaire. The third examination will be provided after 12 months same way. Patients will be in the beginning introduced to doctor only by their unique number. Doctor will be blinded and he will not dispose with information about microinvasive procedure and will examine patient. Data which will be collected: (Visual analogue scale, dermatome where pain is radiating, global pain scale, changes in analgesics drugs consumption). All acquired information will be noted in to the special anonymous protocol. Also patients will anonymously fulfill Oswestry Low Back Disability Questionnaire (ODI). If the patient will need to a see a doctor in the reason of deterioration of pain feeling and if the ODI will not increase more than 10% against patient's origin ODI value than one PRT is allowed in the spinal space responding to a pain radiating dermatome during first six months after patients inclusion to trial. Under the same conditions another PRT is allowed during next six months.

When ODI will increase more than 10% against patient's origin ODI value and more than 1 PRT during six month interval will be needed, than patient will be excluded from the study.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia
    • Czech Republic
  • Czech Republic
    • Praha, Czech Republic, Czechia
      • Algesiology ambulance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age of 18 years or older
• Written informed consent
• Herniated disc, nerve compression, radicular syndromes (vertebrogenic algic syndrome)
• magnetic resonance examination evidence of intervertebral disc herniation
• Pain radiating to the lower limbs
• Disc lesion one level higher than dermatome with pain symptoms

Exclusion Criteria:

• Patients not capable of consenting
• pregnant women or women of child-bearing potential
• Previous spine operations
• Protrusion of more than one intervertebral disc
• Cauda equine syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 1x periradicular therapy in one intervertebral space, corresponding with pain radiating dermatome	Other: periradicular therapy (PRT); RTG controlled periradicular therapy (PRT) is a microinvasive interventional pain release procedure. Advantage of targeted pain therapy is exact administration of effective drugs to the nerve root in the area of the thoracic, lumbar or sacral spines.
Experimental: Group B; 2x periradicular therapy in two intervertebral spaces, the first corresponding with pain radiating dermatome the second according magnetic resonance visualization where stenosis is situated	Other: periradicular therapy (PRT); RTG controlled periradicular therapy (PRT) is a microinvasive interventional pain release procedure. Advantage of targeted pain therapy is exact administration of effective drugs to the nerve root in the area of the thoracic, lumbar or sacral spines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain as assessed by the Visual analogue scale	All acquired information will be noted in to the special anonymous protocol	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain progress as assessed by global pain scale	All acquired information will be noted in to the special anonymous protocol	3 years
Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids	All acquired information will be noted in to the special anonymous protocol	3 years
Pain localization as assessed by note of radiating dermatome as neurologic examination	All acquired information will be noted in to the special anonymous protocol	3 years
Number of extra PRT procedures		3 years

Collaborators and Investigators

• Sponsor: Europainclinics z.ú.
• Investigators: Study Chair: Juraj Mláka, MD PhD, R-Clinic jmlaka@gmail.com

Publications and helpful links

Helpful Links

• website

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Low Back Pain Pain; Periradicular therapy; Spinal Stenosis with neurologic changes
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: 74/EK/15