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A cartilage degradation product, the Fibronectin-Aggrecan complex (FAC), has been identified in patients with degenerative disc disease (DDD). Alpha-2-macroglobulin (A2M) can prevent the formation of the G3 domain of aggrecan, reducing the fibronectin-aggrecan G3 complex and therefore may be an efficacious treatment. The present study was designed to determine 1) the ability of autologous concentrated A2M to relieve back pain in patients with LBP from DDD and 2) the ability of FAC to predict the response to this biologic therapy.
24 patients with low back pain and MRI-concordant DDD had prospective evaluation. Oswestry disability index (ODI) and visual analog scores (VAS) were noted at baseline and at 3- and 6-month follow-up. Primary outcome of clinical improvement was defined as patients with both a decrease in VAS of at least 3 points and ODI >20 points. Molecular discography and delayed FAC analysis and injection of platelet poor plasma at the time of the procedure. Patients with FACT-positive assays were significantly more likely to show improvement in their VAS and ODI at follow-up.
Objectives: A cartilage degradation product, the Fibronectin-Aggrecan complex (FAC), has been identified in patients with degenerative disc disease (DDD). Alpha-2-macroglobulin (A2M) can prevent the formation of the G3 domain of aggrecan, reducing the fibronectin-aggrecan G3 complex and therefore may be an efficacious treatment. The present study was designed to determine 1) the ability of autologous platelet poor plasma (PPP) with concentrated A2M to relieve back pain in patients with low back pain (LBP) from DDD and 2) the ability of FAC to predict the response to this biologic therapy.
Study design/setting: Prospective cohort
Patients: 24 patients with low back pain and MRI-concordant DDD
Methods: All patients underwent lavage for molecular discography and delayed FAC analysis and injection of autologous platelet poor plasma (PPP) rich in A2M (Cytonics Autologous Protease Inhibitor Concentrate, APIC) at the time of the procedure. ANOVA with Bonferonni correction for multiple comparisons was performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| groups that are fac + and - | autologous PPP injection is given to all patients. Prior to injection, a lavage of the disc space is taken to test for FAC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous PPP injection | Other | autologous platelet poor plasma (PPP) injection taken from the participants own blood is injected in to all patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI) | Change from Baseline ODI at 3 and 6 months | 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Score (VAS) | Change from Baseline VAS at 3 and 6 months | 3 and 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with LBP
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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lavage sample of the disc for FAC analysis is taken prior to autologous PPP injection. It was discarded after the analysis was complete.