Degenerative Disc DiseasePhase 4OLDDDNCT04734327
Orthokine Therapy in Lumbar Degenerative Disease
A Phase 4 study testing Orthokine periradicular injection and Orthokine epidural injection in people with Degenerative Disc Disease and Lumbar Region, run by Sutherland Medical Center at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Lumbar Region
- What is being tested?
- Orthokine periradicular injection and Orthokine epidural injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2021to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Sutherland Medical Center
Warsaw, Masovian Voivodeship, 04-036
Piotr Godek, MD, +48 22 67 360 43, piotrgodek.smc@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Orthokine periradicular injection, Orthokine epidural injection
- Keywords
- degenerative disc disease, lumbar spine, conservative treatment, Orthokine
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthokine periradicular injectionProcedure or surgery
Ultrasound guided injections
Orthokine epidural injectionProcedure or surgery
Ultrasound guided injections
| Study group | Role | What they receive |
|---|---|---|
| Orthokine periradicular injection | Experimental | Ultrasound guided injections Receives: Procedure: Orthokine periradicular injection |
| Orthokine epidural injection | Active comparator | Ultrasound guided injections Receives: Procedure: Orthokine epidural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: Time Frame: Change from baseline to 24 weeks
Secondary outcomes (9)
Pain according to Numeric Rating Scale (NRS) from baseline to 4 weeks
0 (no pain) - 10 points (the worst possible pain)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Feb 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sutherland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Godek, Sutherland Medical Center
- Investigators
- Piotr Godek, PhD, Principal investigator, Sutherland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734327
- Sponsor's protocol ID
- SMC2021001
- Acronym
- OLDDD
- Status last verified
- Jan 2021
- First submitted
- 27 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthokine Therapy in Lumbar Degenerative Disease: Does the Route of Administration Really Matter
- ClinicalTrials.gov ID
- NCT04734327
- Acronym / sponsor ID
- OLDDD / SMC2021001
- Conditions
- Degenerative Disc Disease, Lumbar Region
- Keywords
- degenerative disc disease, lumbar spine, conservative treatment, Orthokine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sutherland Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthokine periradicular injection | Experimental | Procedure: Orthokine periradicular injectionUltrasound guided injections |
| Orthokine epidural injection | Active comparator | Procedure: Orthokine epidural injectionUltrasound guided injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthokine periradicular injectionUltrasound guided injections | Procedure or surgery | Orthokine periradicular injection |
| Orthokine epidural injectionUltrasound guided injections | Procedure or surgery | Orthokine epidural injection |
Primary outcome
Change in EQ-5D-5L index from baseline to 24 weeks
Time frame: 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: 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: Time Frame: Change from baseline to 24 weeks
Disease-specific questionnaire. Range: 0 (the best score) - 24 (the worst score).
9 secondary outcomes
Pain according to Numeric Rating Scale (NRS) from baseline to 4 weeks
Time frame: Change from baseline to 4 weeks
Pain according to Numeric Rating Scale (NRS) from baseline to 12 weeks
Time frame: Change from baseline to 12 weeks
Pain according to Numeric Rating Scale (NRS) from baseline to 24 weeks
Time frame: Change from baseline to 24 weeks
Change in EQ-5D-5L index from baseline to 4 week
Time frame: Change from baseline to 4 weeks
Change in EQ-5D-5L index from baseline to 12 week
Time frame: Change from baseline to 12 weeks
Change in Oswestry Disability Index from baseline to 4 weeks
Time frame: Change from baseline to 4 weeks
Change in Oswestry Disability Index from baseline to 12 weeks
Time frame: Change from baseline to 12 weeks
Change in Roland Morris Questionnaire score from baseline to 4 weeks
Time frame: Change from baseline to 4 weeks
Change in Roland Morris Questionnaire score from baseline to 12 weeks
Time frame: Change from baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Godek, PhD principal investigator
Sutherland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Orthokine periradicular injection and Orthokine epidural injection in people with Degenerative Disc Disease and Lumbar Region, run by Sutherland Medical Center at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EQ-5D-5L index from baseline to 24 weeks (time frame: Time Frame: Change from baseline to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.