OLDDD: Orthokine Therapy in Lumbar Degenerative Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Change in EQ-5D-5L index from baseline to 24 weeks [Time Frame: Change 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.
- Change in Oswestry Disability Index from baseline to 24 weeks [Time Frame: Change from baseline to 24 weeks]
Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
- Change in Roland Morris Questionnaire score from baseline to 24 weeks [Time Frame: Change from baseline to 24 weeks]
Disease-specific questionnaire. Range: 0 (the best score) - 24 (the worst score).
Secondary Outcome Measures
- Pain according to Numeric Rating Scale (NRS) from baseline to 4 weeks [Change from baseline to 4 weeks]
0 (no pain) - 10 points (the worst possible pain)
- Pain according to Numeric Rating Scale (NRS) from baseline to 12 weeks [Change from baseline to 12 weeks]
0 (no pain) - 10 points (the worst possible pain)
- Pain according to Numeric Rating Scale (NRS) from baseline to 24 weeks [Change from baseline to 24 weeks]
0 (no pain) - 10 points (the worst possible pain)
- Change in EQ-5D-5L index from baseline to 4 week [Change from baseline to 4 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.
- Change in EQ-5D-5L index from baseline to 12 week [Change from baseline to 12 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.
- Change in Oswestry Disability Index from baseline to 4 weeks [Change from baseline to 4 weeks]
Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
- Change in Oswestry Disability Index from baseline to 12 weeks [Change from baseline to 12 weeks]
Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
- Change in Roland Morris Questionnaire score from baseline to 4 weeks [Change from baseline to 4 weeks]
Disease-specific questionnaire. Range: 0 (the best score) - 24 (the worst score).
- Change in Roland Morris Questionnaire score from baseline to 12 weeks [Change from baseline to 12 weeks]
Disease-specific questionnaire. Range: 0 (the best score) - 24 (the worst score).
Eligibility Criteria
Criteria
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)
-
Lack of consent to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sutherland Medical Center | Warsaw | Mazowieckie | Poland | 04-036 |
Sponsors and Collaborators
- Sutherland Medical Center
Investigators
- Principal Investigator: Piotr Godek, PhD, Sutherland Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SMC2021001