Long-term Investigation of Annulargrams and Intra-annular Fibrin to Treat Chronic Discogenic Low Back Pain and Radiculopathy: 1-, 2-, and 3-Year Outcome Comparisons of Patients with and without Prior Surgery
Discogenic chronic low back pain (cLBP) and radiculopathy are the most prevalent causes of disability worldwide. Older spine treatments often lack reliability and are associated with adverse events. Among surgical treatment options, discectomies weaken discs, and fusions cause direct damage to adjac...
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description | Discogenic chronic low back pain (cLBP) and radiculopathy are the most prevalent causes of disability worldwide. Older spine treatments often lack reliability and are associated with adverse events. Among surgical treatment options, discectomies weaken discs, and fusions cause direct damage to adjacent discs, so both treatments accelerate disc degeneration. Other regenerative medicine treatments, including "stem cell" (centrifuged bone marrow aspirate, BMC), and platelet-rich plasma (PRP), lack fibrin's bio-adhesive properties. Specifically, fibrin is a strong bio-adhesive, so it immediately integrates into disc defects and binds there, becoming a part of the disc and facilitating new disc tissue growth.
To evaluate the safety and efficacy of this new pragmatic algorithm that both diagnoses and treats cLBP by (i) first identifying annulus fibrosus tears (fissures) in the region of symptoms and (ii) subsequently treating those tears by introducing fibrin to seal them and facilitate new tissue growth.
Retrospective cohort study that prospectively reported validated measures in a registry.
Private, single-center, specialized, interventional pain management institution.
The patients we decided to observe had suffered from cLBP with or without radiculopathy symptoms in their legs for greater than 6 months. Prior to enrollment, all patients underwent physical therapy and at least 4 invasive treatments without relief. Failed treatments included BMC or PRP injections, intradiscal or intraarticular zygapophyseal joints, or combinations of both. Fluoroscopically guided epidural injections of corticosteroids or PRP were additional failed treatments, as were radiofrequency neurotomies in the medial branch. Candidacy for enrollment was based on meeting the aforementioned criteria and by having magnetic resonance image (MRI) screenings (1.5 T) and plain-film radiographs performed 6 months before treatment. In addition, those MRI screenings and radiographs had to rule out the following concomitant conditions: (i) carcinoma, (ii) fracture, (iii) instability, or (iv) severe vertebral canal or intervertebral foramen stenosis.
Significant improvement was demonstrated at one, 2, and 3 years after treatment in all outcome measures. The mean duration of low back pain prior to treatment was 11.2 years. Patients' mean age was 56 years. Thirty percent of the patients were female, and 70% were male. Both the failed surgery cohort and nonsurgery cohort demonstrated significant impro |
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To evaluate the safety and efficacy of this new pragmatic algorithm that both diagnoses and treats cLBP by (i) first identifying annulus fibrosus tears (fissures) in the region of symptoms and (ii) subsequently treating those tears by introducing fibrin to seal them and facilitate new tissue growth.
Retrospective cohort study that prospectively reported validated measures in a registry.
Private, single-center, specialized, interventional pain management institution.
The patients we decided to observe had suffered from cLBP with or without radiculopathy symptoms in their legs for greater than 6 months. Prior to enrollment, all patients underwent physical therapy and at least 4 invasive treatments without relief. Failed treatments included BMC or PRP injections, intradiscal or intraarticular zygapophyseal joints, or combinations of both. Fluoroscopically guided epidural injections of corticosteroids or PRP were additional failed treatments, as were radiofrequency neurotomies in the medial branch. Candidacy for enrollment was based on meeting the aforementioned criteria and by having magnetic resonance image (MRI) screenings (1.5 T) and plain-film radiographs performed 6 months before treatment. In addition, those MRI screenings and radiographs had to rule out the following concomitant conditions: (i) carcinoma, (ii) fracture, (iii) instability, or (iv) severe vertebral canal or intervertebral foramen stenosis.
Significant improvement was demonstrated at one, 2, and 3 years after treatment in all outcome measures. The mean duration of low back pain prior to treatment was 11.2 years. Patients' mean age was 56 years. Thirty percent of the patients were female, and 70% were male. Both the failed surgery cohort and nonsurgery cohort demonstrated significant improvement after fibrin treatment, with the failed surgery cohort realizing greater relative improvement. Significant improvements in the Oswestry disability index (ODI), visual analog scale, and PROMIS® (mental and physical) scores were consistent across age, gender, comorbidity, and exposure status. At the 12-month follow-up, 50% of patients achieved minimal clinically important differences utilizing the ODI. No severe adverse events were reported.
Limitations include patient demographic factors, outcome-measure sensitivity, and that the outcomes were reported prospectively and calculated retrospectively as one-, 2-, and 3-year time frames were attained. Although categorical analyses comparing the prior surgical cohort to the nonsurgical cohort were performed, other pre-enrollment treatments were not categorized for comparison.
Intra-annular fibrin bio-adhesive sealant demonstrates the ability to be an effective treatment for alleviating discogenic cLBP and radiculopathy for at least 3 years, even in patients who all failed multiple prior treatments, including discectomy, fusion, disc PRP, or BMC. The results suggest the benefits of fibrin sealant. Future investigations to consider include a randomized double-blind controlled trial and further categorical analyses.</description><identifier>ISSN: 1533-3159</identifier><identifier>ISSN: 2150-1149</identifier><identifier>EISSN: 2150-1149</identifier><identifier>PMID: 39621982</identifier><language>eng</language><publisher>United States: American Society of Interventional Pain Physician</publisher><subject>Adhesives ; Adult ; Annulus Fibrosus ; Back pain ; Cohort Studies ; Female ; Fibrin - therapeutic use ; Humans ; Intervertebral Disc - surgery ; Low Back Pain - drug therapy ; Low Back Pain - etiology ; Male ; Middle Aged ; Radiculopathy - drug therapy ; Retrospective Studies ; Surgery ; Treatment Outcome</subject><ispartof>Pain physician, 2024-11, Vol.27 (8), p.537</ispartof><rights>2024. This work is published under https://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39621982$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pauza, Kevin</creatorcontrib><creatorcontrib>Boachie-Adjei, Kwadwo</creatorcontrib><creatorcontrib>Nguyen, Joseph T</creatorcontrib><creatorcontrib>Hussey Iv, Francis</creatorcontrib><creatorcontrib>Sutton, Jacob</creatorcontrib><creatorcontrib>Serwaa-Sarfo, Akua</creatorcontrib><creatorcontrib>Ercole, Patrick M</creatorcontrib><creatorcontrib>Wright, Carrie</creatorcontrib><creatorcontrib>Murrell, William D</creatorcontrib><title>Long-term Investigation of Annulargrams and Intra-annular Fibrin to Treat Chronic Discogenic Low Back Pain and Radiculopathy: 1-, 2-, and 3-Year Outcome Comparisons of Patients with and without Prior Surgery</title><title>Pain physician</title><addtitle>Pain Physician</addtitle><description>Discogenic chronic low back pain (cLBP) and radiculopathy are the most prevalent causes of disability worldwide. Older spine treatments often lack reliability and are associated with adverse events. Among surgical treatment options, discectomies weaken discs, and fusions cause direct damage to adjacent discs, so both treatments accelerate disc degeneration. Other regenerative medicine treatments, including "stem cell" (centrifuged bone marrow aspirate, BMC), and platelet-rich plasma (PRP), lack fibrin's bio-adhesive properties. Specifically, fibrin is a strong bio-adhesive, so it immediately integrates into disc defects and binds there, becoming a part of the disc and facilitating new disc tissue growth.
To evaluate the safety and efficacy of this new pragmatic algorithm that both diagnoses and treats cLBP by (i) first identifying annulus fibrosus tears (fissures) in the region of symptoms and (ii) subsequently treating those tears by introducing fibrin to seal them and facilitate new tissue growth.
Retrospective cohort study that prospectively reported validated measures in a registry.
Private, single-center, specialized, interventional pain management institution.
The patients we decided to observe had suffered from cLBP with or without radiculopathy symptoms in their legs for greater than 6 months. Prior to enrollment, all patients underwent physical therapy and at least 4 invasive treatments without relief. Failed treatments included BMC or PRP injections, intradiscal or intraarticular zygapophyseal joints, or combinations of both. Fluoroscopically guided epidural injections of corticosteroids or PRP were additional failed treatments, as were radiofrequency neurotomies in the medial branch. Candidacy for enrollment was based on meeting the aforementioned criteria and by having magnetic resonance image (MRI) screenings (1.5 T) and plain-film radiographs performed 6 months before treatment. In addition, those MRI screenings and radiographs had to rule out the following concomitant conditions: (i) carcinoma, (ii) fracture, (iii) instability, or (iv) severe vertebral canal or intervertebral foramen stenosis.
Significant improvement was demonstrated at one, 2, and 3 years after treatment in all outcome measures. The mean duration of low back pain prior to treatment was 11.2 years. Patients' mean age was 56 years. Thirty percent of the patients were female, and 70% were male. Both the failed surgery cohort and nonsurgery cohort demonstrated significant improvement after fibrin treatment, with the failed surgery cohort realizing greater relative improvement. Significant improvements in the Oswestry disability index (ODI), visual analog scale, and PROMIS® (mental and physical) scores were consistent across age, gender, comorbidity, and exposure status. At the 12-month follow-up, 50% of patients achieved minimal clinically important differences utilizing the ODI. No severe adverse events were reported.
Limitations include patient demographic factors, outcome-measure sensitivity, and that the outcomes were reported prospectively and calculated retrospectively as one-, 2-, and 3-year time frames were attained. Although categorical analyses comparing the prior surgical cohort to the nonsurgical cohort were performed, other pre-enrollment treatments were not categorized for comparison.
Intra-annular fibrin bio-adhesive sealant demonstrates the ability to be an effective treatment for alleviating discogenic cLBP and radiculopathy for at least 3 years, even in patients who all failed multiple prior treatments, including discectomy, fusion, disc PRP, or BMC. The results suggest the benefits of fibrin sealant. Future investigations to consider include a randomized double-blind controlled trial and further categorical analyses.</description><subject>Adhesives</subject><subject>Adult</subject><subject>Annulus Fibrosus</subject><subject>Back pain</subject><subject>Cohort Studies</subject><subject>Female</subject><subject>Fibrin - therapeutic use</subject><subject>Humans</subject><subject>Intervertebral Disc - surgery</subject><subject>Low Back Pain - drug therapy</subject><subject>Low Back Pain - etiology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Radiculopathy - drug therapy</subject><subject>Retrospective Studies</subject><subject>Surgery</subject><subject>Treatment Outcome</subject><issn>1533-3159</issn><issn>2150-1149</issn><issn>2150-1149</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNpdkU1v1DAQhi0EotulfwFZ4sIBS_5KsuZWtrRUWqkrWg49rSaON-uS2MEfVPsr-Ut1aLlwGM1o5tGrd2ZeoQVnFSWMSfUaLVglBBGsUifoNMYHSkWtlHiLToSqOVMrvkB_Nt71JJkw4mv328Rke0jWO-z3-Ny5PEDoA4wRg-sKkQIQeG7jS9sG63Dy-C4YSHh9CN5ZjS9s1L43c7nxj_gL6J94C4WcJb5DZ3Ue_ATpcPyMGfmEeYl5JMi9KbI3OWk_Grz24wTBRu_ibGZbbBmXIn606fCXnwufE94G6wO-zaE34fgOvdnDEM3ZS16iH5df79bfyObm6np9viETq1UiDGqhZFXLjhohNZVtrRreGCM6QVtFm7YugNaaSy3bqmkECFpT6OTetHQlxRJ9fNadgv-Vy912Y1nbDAM443PcCSap4pytVgX98B_64HNwxd1McSW4Kn9aovcvVG5H0-2mYEcIx92_V4knvhGRgg</recordid><startdate>20241101</startdate><enddate>20241101</enddate><creator>Pauza, Kevin</creator><creator>Boachie-Adjei, Kwadwo</creator><creator>Nguyen, Joseph T</creator><creator>Hussey Iv, Francis</creator><creator>Sutton, Jacob</creator><creator>Serwaa-Sarfo, Akua</creator><creator>Ercole, Patrick M</creator><creator>Wright, Carrie</creator><creator>Murrell, William D</creator><general>American Society of Interventional Pain Physician</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>COVID</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20241101</creationdate><title>Long-term Investigation of Annulargrams and Intra-annular Fibrin to Treat Chronic Discogenic Low Back Pain and Radiculopathy: 1-, 2-, and 3-Year Outcome Comparisons of Patients with and without Prior Surgery</title><author>Pauza, Kevin ; Boachie-Adjei, Kwadwo ; Nguyen, Joseph T ; Hussey Iv, Francis ; Sutton, Jacob ; Serwaa-Sarfo, Akua ; Ercole, Patrick M ; Wright, Carrie ; Murrell, William D</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p169t-1a6394564d0e34c04b69727ee3d30b907b6639ccc24c4b5773a3060ad4feb0843</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adhesives</topic><topic>Adult</topic><topic>Annulus Fibrosus</topic><topic>Back pain</topic><topic>Cohort Studies</topic><topic>Female</topic><topic>Fibrin - therapeutic use</topic><topic>Humans</topic><topic>Intervertebral Disc - surgery</topic><topic>Low Back Pain - drug therapy</topic><topic>Low Back Pain - etiology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Radiculopathy - drug therapy</topic><topic>Retrospective Studies</topic><topic>Surgery</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pauza, Kevin</creatorcontrib><creatorcontrib>Boachie-Adjei, Kwadwo</creatorcontrib><creatorcontrib>Nguyen, Joseph T</creatorcontrib><creatorcontrib>Hussey Iv, Francis</creatorcontrib><creatorcontrib>Sutton, Jacob</creatorcontrib><creatorcontrib>Serwaa-Sarfo, Akua</creatorcontrib><creatorcontrib>Ercole, Patrick M</creatorcontrib><creatorcontrib>Wright, Carrie</creatorcontrib><creatorcontrib>Murrell, William D</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>ProQuest Central (Corporate)</collection><collection>ProQuest Nursing and Allied Health Journals</collection><collection>Health & Medical Collection (Proquest)</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Coronavirus Research Database</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content (ProQuest)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Pain physician</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pauza, Kevin</au><au>Boachie-Adjei, Kwadwo</au><au>Nguyen, Joseph T</au><au>Hussey Iv, Francis</au><au>Sutton, Jacob</au><au>Serwaa-Sarfo, Akua</au><au>Ercole, Patrick M</au><au>Wright, Carrie</au><au>Murrell, William D</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term Investigation of Annulargrams and Intra-annular Fibrin to Treat Chronic Discogenic Low Back Pain and Radiculopathy: 1-, 2-, and 3-Year Outcome Comparisons of Patients with and without Prior Surgery</atitle><jtitle>Pain physician</jtitle><addtitle>Pain Physician</addtitle><date>2024-11-01</date><risdate>2024</risdate><volume>27</volume><issue>8</issue><spage>537</spage><pages>537-</pages><issn>1533-3159</issn><issn>2150-1149</issn><eissn>2150-1149</eissn><abstract>Discogenic chronic low back pain (cLBP) and radiculopathy are the most prevalent causes of disability worldwide. Older spine treatments often lack reliability and are associated with adverse events. Among surgical treatment options, discectomies weaken discs, and fusions cause direct damage to adjacent discs, so both treatments accelerate disc degeneration. Other regenerative medicine treatments, including "stem cell" (centrifuged bone marrow aspirate, BMC), and platelet-rich plasma (PRP), lack fibrin's bio-adhesive properties. Specifically, fibrin is a strong bio-adhesive, so it immediately integrates into disc defects and binds there, becoming a part of the disc and facilitating new disc tissue growth.
To evaluate the safety and efficacy of this new pragmatic algorithm that both diagnoses and treats cLBP by (i) first identifying annulus fibrosus tears (fissures) in the region of symptoms and (ii) subsequently treating those tears by introducing fibrin to seal them and facilitate new tissue growth.
Retrospective cohort study that prospectively reported validated measures in a registry.
Private, single-center, specialized, interventional pain management institution.
The patients we decided to observe had suffered from cLBP with or without radiculopathy symptoms in their legs for greater than 6 months. Prior to enrollment, all patients underwent physical therapy and at least 4 invasive treatments without relief. Failed treatments included BMC or PRP injections, intradiscal or intraarticular zygapophyseal joints, or combinations of both. Fluoroscopically guided epidural injections of corticosteroids or PRP were additional failed treatments, as were radiofrequency neurotomies in the medial branch. Candidacy for enrollment was based on meeting the aforementioned criteria and by having magnetic resonance image (MRI) screenings (1.5 T) and plain-film radiographs performed 6 months before treatment. In addition, those MRI screenings and radiographs had to rule out the following concomitant conditions: (i) carcinoma, (ii) fracture, (iii) instability, or (iv) severe vertebral canal or intervertebral foramen stenosis.
Significant improvement was demonstrated at one, 2, and 3 years after treatment in all outcome measures. The mean duration of low back pain prior to treatment was 11.2 years. Patients' mean age was 56 years. Thirty percent of the patients were female, and 70% were male. Both the failed surgery cohort and nonsurgery cohort demonstrated significant improvement after fibrin treatment, with the failed surgery cohort realizing greater relative improvement. Significant improvements in the Oswestry disability index (ODI), visual analog scale, and PROMIS® (mental and physical) scores were consistent across age, gender, comorbidity, and exposure status. At the 12-month follow-up, 50% of patients achieved minimal clinically important differences utilizing the ODI. No severe adverse events were reported.
Limitations include patient demographic factors, outcome-measure sensitivity, and that the outcomes were reported prospectively and calculated retrospectively as one-, 2-, and 3-year time frames were attained. Although categorical analyses comparing the prior surgical cohort to the nonsurgical cohort were performed, other pre-enrollment treatments were not categorized for comparison.
Intra-annular fibrin bio-adhesive sealant demonstrates the ability to be an effective treatment for alleviating discogenic cLBP and radiculopathy for at least 3 years, even in patients who all failed multiple prior treatments, including discectomy, fusion, disc PRP, or BMC. The results suggest the benefits of fibrin sealant. Future investigations to consider include a randomized double-blind controlled trial and further categorical analyses.</abstract><cop>United States</cop><pub>American Society of Interventional Pain Physician</pub><pmid>39621982</pmid><oa>free_for_read</oa></addata></record> |
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subjects | Adhesives Adult Annulus Fibrosus Back pain Cohort Studies Female Fibrin - therapeutic use Humans Intervertebral Disc - surgery Low Back Pain - drug therapy Low Back Pain - etiology Male Middle Aged Radiculopathy - drug therapy Retrospective Studies Surgery Treatment Outcome |
title | Long-term Investigation of Annulargrams and Intra-annular Fibrin to Treat Chronic Discogenic Low Back Pain and Radiculopathy: 1-, 2-, and 3-Year Outcome Comparisons of Patients with and without Prior Surgery |
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