NCT04734327

Brief Summary

The aim of the trial is the comparison of the effectiveness of two methods of Orthokine administration (periradicular or epidural) in lumbar degenerative disc disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

January 27, 2021

Last Update Submit

February 1, 2021

Conditions

Degenerative Disc DiseaseLumbar Region

Keywords

degenerative disc diseaselumbar spineconservative treatmentOrthokine

Outcome Measures

Primary Outcomes (3)

  • Change in EQ-5D-5L index from baseline to 24 weeks

    EQ-5D-5L index estimated from EQ-5D-5L descriptive system based on Polish directly measured value set. Minimum: -0.590; Maximum: 1.0; More points means better outcome.

    Time Frame: Change from baseline to 24 weeks

  • Change in Oswestry Disability Index from baseline to 24 weeks

    Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).

    Time Frame: Change from baseline to 24 weeks

  • Change in Roland Morris Questionnaire score from baseline to 24 weeks

    Disease-specific questionnaire. Range: 0 (the best score) - 24 (the worst score).

    Time Frame: Change from baseline to 24 weeks

Secondary Outcomes (9)

  • Pain according to Numeric Rating Scale (NRS) from baseline to 4 weeks

    Change from baseline to 4 weeks

  • Pain according to Numeric Rating Scale (NRS) from baseline to 12 weeks

    Change from baseline to 12 weeks

  • Pain according to Numeric Rating Scale (NRS) from baseline to 24 weeks

    Change from baseline to 24 weeks

  • Change in EQ-5D-5L index from baseline to 4 week

    Change from baseline to 4 weeks

  • Change in EQ-5D-5L index from baseline to 12 week

    Change from baseline to 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Orthokine periradicular injection

EXPERIMENTAL

Ultrasound guided injections

Procedure: Orthokine periradicular injection

Orthokine epidural injection

ACTIVE COMPARATOR

Ultrasound guided injections

Procedure: Orthokine epidural injection

Interventions

Orthokine periradicular injectionPROCEDURE

Ultrasound guided injections

Orthokine periradicular injection
Orthokine epidural injectionPROCEDURE

Ultrasound guided injections

Orthokine epidural injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical symptoms of LDDD in the lumbar region
  • LDDD confirmed by MRI
  • No contraindications to injections (hemorrhagic diathesis, anticoagulants, skin lesions)
  • An adult consenting to participate in the study

You may not qualify if:

  • Presence of severe neurological deficits requiring surgery
  • Discopathy of other origin - traumatic, spondylolisthesis, cancer, infection, inflammatory systemic diseases
  • Previous surgical treatment in the lumbar spine
  • Mental state that prevents cooperation during injection
  • Contraindications for injection (hemorrhagic diathesis, anticoagulants, skin lesions)
  • \. Lack of consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sutherland Medical Center

Warsaw, Masovian Voivodeship, 04-036, Poland

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Piotr Godek, PhD

    Sutherland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 2, 2021

Study Start

February 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)