EuroPainClinics® Study I (Prospective Trial)

NCT02464553 | Terminated DMC

• 1 other identifier: 74/EK/15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lumbar Spinal Stenosis

Keywords

Low Back Pain Pain; Periradicular therapy; Spinal Stenosis with neurologic changes

Outcome Measures

Primary Outcomes (1)

• Pain as assessed by the Visual analogue scale

  All acquired information will be noted in to the special anonymous protocol

  3 years

Secondary Outcomes (4)

• Pain progress as assessed by global pain scale

  3 years

• Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids

  3 years

• Pain localization as assessed by note of radiating dermatome as neurologic examination

  3 years

• Number of extra PRT procedures

  3 years

Study Arms (2)

Group A

EXPERIMENTAL

1x periradicular therapy in one intervertebral space, corresponding with pain radiating dermatome

Other: periradicular therapy (PRT)

Group B

EXPERIMENTAL

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)

Interventions

periradicular therapy (PRT) OTHER

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.

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Europainclinics z.ú.: lead

Study Sites (2)

Algesiology ambulance

Prague, Czech Republic, Czechia

Location

Czech republic

Prague, Czechia

Location

Related Links

• website

MeSH Terms

Conditions

Spinal Stenosis; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juraj Mláka, MD PhD

  R-Clinic jmlaka@gmail.com

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 8, 2015
• Study Start: May 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 30, 2021
• Last Updated: January 13, 2022

Record last verified: 2021-12

Locations

CZ (2)