Clinical trial NCT04734327: Orthokine Therapy in Lumbar Degenerative Disease
Official title: Orthokine Therapy in Lumbar Degenerative Disease: Does the Route of Administration Really Matter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Degenerative Disc Disease
Lumbar Region
Keywords: degenerative disc disease
lumbar spine
conservative treatment
Orthokine
Lead sponsor: Sutherland Medical Center
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in EQ-5D-5L index from baseline to 24 weeks
timeFrame: Time Frame: Change from baseline to 24 weeks
measure: Change in Oswestry Disability Index from baseline to 24 weeks
timeFrame: Time Frame: Change from baseline to 24 weeks
measure: Change in Roland Morris Questionnaire score from baseline to 24 weeks
timeFrame: Time Frame: Change from baseline to 24 weeks
Secondary outcomes:
measure: Pain according to Numeric Rating Scale (NRS) from baseline to 4 weeks
timeFrame: Change from baseline to 4 weeks
measure: Pain according to Numeric Rating Scale (NRS) from baseline to 12 weeks
timeFrame: Change from baseline to 12 weeks
measure: Pain according to Numeric Rating Scale (NRS) from baseline to 24 weeks
timeFrame: Change from baseline to 24 weeks
measure: Change in EQ-5D-5L index from baseline to 4 week
timeFrame: Change from baseline to 4 weeks
measure: Change in EQ-5D-5L index from baseline to 12 week
timeFrame: Change from baseline to 12 weeks
measure: Change in Oswestry Disability Index from baseline to 4 weeks
timeFrame: Change from baseline to 4 weeks
measure: Change in Oswestry Disability Index from baseline to 12 weeks
timeFrame: Change from baseline to 12 weeks
measure: Change in Roland Morris Questionnaire score from baseline to 4 weeks
timeFrame: Change from baseline to 4 weeks
measure: Change in Roland Morris Questionnaire score from baseline to 12 weeks
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Sutherland Medical Center
state: Mazowieckie
Study officials:
affiliation: Sutherland Medical Center
name: Piotr Godek, PhD
role: PRINCIPAL_INVESTIGATOR
References: