Orthokine Therapy in Lumbar Degenerative Disease

NCT ID: NCT04734327

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-12-31

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.

Detailed Description

BACKGROUND: Lumbar Degenerative Disc Disease (LDDD) is a serious, global health problem for patients from the third decade of life. It is assumed that 75-85% of the population suffer from pain in the lumbar spine at least once during their lifetime (vital morbidity), and 3-5% of the population suffer from root-type pain.

The annual prevalence of the spine complaints in the United States alone ranges from 15 to 20%, and in Europe it ranges from 25 to 45%.

In addition to the immeasurable losses associated with impaired patient activity and a significant reduction in the quality of their life, LBP is the greatest burden for the world economy, measured by the years lived with disability (YLD) index due to a significant reduction in the productivity and professional ability of patients affected by LBP.

AIM: Assessment of the effectiveness of symptomatic treatment of Lumbar Degenerative Disc Disease (LDDD) with the autologous Orthokine serum, comparison of two methods of its application - epidural or periradicular.

DESIGN: Randomized prospective trial without blinding SETTING: Open study for outpatients, single center study POPULATION: local population METHODS: Two groups of patients (A, B) with confirmed LDDD by MRI, without gender or age limitation, meeting the health conditions according to the inclusion and exclusion criteria. There will be 50 people in each group (100 people in total).

Group A - therapy with Orthokine serum - a total of 4 injections of 2 doses at weekly intervals (4 doses of 4 ml of serum in total), injections will be performed into the epidural space from an interlaminar access under ultrasound guidance by the same operator.

Group B - therapy with Orthokine serum - a total of 4 injections of 1 or 2 doses depending on the number of levels occupied at weekly intervals (a total of 4 doses of 4 ml of serum), injections will be performed periradicular (transforaminal) under ultrasound guidance by the same operator.

Assessment tools: Numeric Rating Scale NRS (0-10), Oswestry Disability Index questionnaire, Roland Morris questionnaire, EQ-5D-5L questionnaire Control points W0 - before the therapy, W1 - 1 month after the last dose of serum W2 - 3 months after the last dose of serum W3 - 6 months after the last serum dose.

Conditions

Degenerative Disc Disease; Lumbar Region

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Orthokine periradicular injection

Ultrasound guided injections

Group Type: EXPERIMENTAL

Orthokine periradicular injection

Intervention Type: PROCEDURE

Ultrasound guided injections

Orthokine epidural injection

Ultrasound guided injections

Group Type: ACTIVE_COMPARATOR

Orthokine epidural injection

Intervention Type: PROCEDURE

Ultrasound guided injections

Interventions

Orthokine periradicular injection

Ultrasound guided injections

Intervention Type: PROCEDURE

Orthokine epidural injection

Ultrasound guided injections

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Clinical symptoms of LDDD in the lumbar region

2. LDDD confirmed by MRI

3. No contraindications to injections (hemorrhagic diathesis, anticoagulants, skin lesions)

4. An adult consenting to participate in the study

Exclusion Criteria

1. Presence of severe neurological deficits requiring surgery

2. Discopathy of other origin - traumatic, spondylolisthesis, cancer, infection, inflammatory systemic diseases

3. Previous surgical treatment in the lumbar spine

4. Mental state that prevents cooperation during injection

5. Contraindications for injection (hemorrhagic diathesis, anticoagulants, skin lesions)

5. Lack of consent to participate in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sutherland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Piotr Godek

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Piotr Godek, PhD

Role: PRINCIPAL_INVESTIGATOR

Sutherland Medical Center

Locations

Sutherland Medical Center

Warsaw, Masovian Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Facility Contacts

Piotr Godek, MD

Role: primary

piotrgodek.smc@gmail.com

+48 22 67 360 43

Other Identifiers

SMC2021001

Identifier Type: -

Identifier Source: org_study_id