Orthokine Therapy in Lumbar Degenerative Disease

Degenerative Disc Disease Clinical Trial

— OLDDD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04734327
• Other study ID #: SMC2021001
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2021
• Source: Sutherland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Lumbar Region

Intervention

Procedure:
• Orthokine periradicular injection
Ultrasound guided injections
• Orthokine epidural injection
Ultrasound guided injections

Locations

Country	Name	City	State
Poland	Sutherland Medical Center	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Sutherland Medical Center

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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