Orthokine Therapy in Lumbar Degenerative Disease (OLDDD)

Orthokine Therapy in Lumbar Degenerative Disease: Does the Route of Administration Really Matter

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.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease; Lumbar Region
• Intervention / Treatment: Procedure: Orthokine periradicular injection; Procedure: Orthokine epidural injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 04-036
      • Recruiting
      • Sutherland Medical Center
      • Contact: Piotr Godek, MD; Phone Number: +48 22 67 360 43; Email: piotrgodek.smc@gmail.com

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orthokine periradicular injection; Ultrasound guided injections	Procedure: Orthokine periradicular injection; Ultrasound guided injections
Active Comparator: Orthokine epidural injection; Ultrasound guided injections	Procedure: Orthokine epidural injection; Ultrasound guided injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain according to Numeric Rating Scale (NRS) from baseline to 4 weeks	0 (no pain) - 10 points (the worst possible pain)	Change from baseline to 4 weeks
Pain according to Numeric Rating Scale (NRS) from baseline to 12 weeks	0 (no pain) - 10 points (the worst possible pain)	Change from baseline to 12 weeks
Pain according to Numeric Rating Scale (NRS) from baseline to 24 weeks	0 (no pain) - 10 points (the worst possible pain)	Change from baseline to 24 weeks
Change in EQ-5D-5L index from baseline to 4 week	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.	Change from baseline to 4 weeks
Change in EQ-5D-5L index from baseline to 12 week	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.	Change from baseline to 12 weeks
Change in Oswestry Disability Index from baseline to 4 weeks	Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).	Change from baseline to 4 weeks
Change in Oswestry Disability Index from baseline to 12 weeks	Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).	Change from baseline to 12 weeks
Change in Roland Morris Questionnaire score from baseline to 4 weeks	Disease-specific questionnaire. Range: 0 (the best score) - 24 (the worst score).	Change from baseline to 4 weeks
Change in Roland Morris Questionnaire score from baseline to 12 weeks	Disease-specific questionnaire. Range: 0 (the best score) - 24 (the worst score).	Change from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Sutherland Medical Center
• Investigators: Principal Investigator: Piotr Godek, PhD, Sutherland Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: lumbar spine; conservative treatment; degenerative disc disease; Orthokine
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: SMC2021001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No