NCT02461654

Brief Summary

In this prospective observational trial the effect of the Disc FX microinvasive therapy should be examined in (approximately 150) adult patients with low back pain.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
3.6 years until next milestone

Study Start

First participant enrolled

December 31, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

2.4 years

First QC Date

May 26, 2015

Last Update Submit

December 30, 2021

Conditions

Disc Herniations

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 (3)

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

    3 years

  • 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

Interventions

Disc FXOTHER

Disc FX is an innovative system allowing for a safe and effective approach to a damaged disc without injury to the surrounding structures. The procedure consists of three phases: during the first phase, the disc is punctured with a special needle that functions as a working channel. This needle is used to remove part of the degenerate inner tissue. Then, using a radio-frequency probe, the disc is sealed to minimize the risk of repeated herniation. In the final step, the pathological nerves in the back part of the disc are destroyed with the use of radio-frequency.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Trial will compare evolution of patient's health state, changes of low back pain and other neurological conditions during time period (6 and 12 month) after miniivasive interventional algesiologic procedure - disc FX.

You may qualify if:

  • Patients who undergo Disc FX therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algesiology ambulance

Prague, Czechia

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Juraj Mláka, MD PhD

    R-Clinic

    STUDY CHAIR

  • Ladislav Kočan, MD PhD

    K-medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 3, 2015

Study Start

December 31, 2018

Primary Completion

May 31, 2021

Study Completion

December 31, 2021

Last Updated

January 13, 2022

Record last verified: 2021-12

Locations

CZ(1)