Orthokine Therapy in Lumbar Degenerative Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Degenerative Disc Disease, Lumbar Region

Intervention / Treatment
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* Procedure: Orthokine periradicular injection
* Procedure: Orthokine epidural injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) 5. Lack of consent to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orthokine periradicular injection<br>Ultrasound guided injections | Procedure: Orthokine periradicular injection<br>* Ultrasound guided injections<br>|
| Active Comparator: Orthokine epidural injection<br>Ultrasound guided injections | Procedure: Orthokine epidural injection<br>* Ultrasound guided injections<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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degenerative disc disease, lumbar spine, conservative treatment, Orthokine