TY - JOUR
T1 - The effectiveness of intradiscal biologic treatments for discogenic low back pain
T2 - a systematic review
AU - Schneider, Byron J.
AU - Hunt, Christine
AU - Conger, Aaron
AU - Qu, Wenchun
AU - Maus, Timothy P.
AU - Vorobeychik, Yakov
AU - Cheng, Jianguo
AU - Duszynski, Belinda
AU - McCormick, Zachary L.
N1 - Funding Information:
The authors wish to express our deepest gratitude to Patricia Erwin, MLS, who performed the literature searches for this systematic review and Danielle (Dana) Gerberi, who formulated the literature search description and created Appendix 1. Author disclosure: BJS: Consulting: State Farm (D), AIM Specialty (B), Speaking and/or Teaching Arrangements: NASS (A), Grant: Spine Intervention Society (E). CH: Grant: Nevro (C), Abbott (F). AC: Nothing to disclose. WQ: Board of Directors: American Collage of Regenerative Medicine, Scientific Advisory Board/Other Office: Alliance of Cell Therapy New. TPM: Trips/Travel: Spine Intervention Society Travel reimbursement(A), Board of Directors: Spine Intervention Society Travel reimbursement(A). YV: Nothing to disclose. JC: Nothing to disclose. BD: Nothing to disclose. ZLM: Research Support (Investigator Salary, Staff/Materials): Skagg Research Foundation, Eliska, (G) paid directly to my institution for a randomized controlled trial related to a propriety biologic agent for spinal indications.
Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2022/2
Y1 - 2022/2
N2 - BACKGROUND CONTEXT: There are limited treatments for discogenic low back pain. Intradiscal injections of biologic agents such as platelet-rich plasma (PRP) or stem cells (SC) are theorized to have regenerative properties and have gained increasing interest as a possible treatment, but the evidence supporting their use in clinical practice is not yet well-defined. PURPOSE: Determine the effectiveness of intradiscal biologics for treating discogenic low back pain. STUDY DESIGN: PRISMA-compliant systematic review. PATIENT SAMPLE: Patients with discogenic low back pain confirmed by provocation discography or clinical and imaging findings consistent with discogenic pain. OUTCOME MEASURES: The primary outcome was the proportion of individuals with ≥50% pain relief after intradiscal biologic injection at 6 months. Secondary outcomes included ≥2-point pain score reduction on NRS; patient satisfaction; functional improvement; decreased use of other health care, including analgesics and surgery; and structural disc changes on MRI. METHODS: Comprehensive literature search performed in 2018 and updated in 2020. Interventions included were biologic therapies including mesenchymal stem cells, platelet rich plasma, microfragmented fat, amniotic membrane-based injectates, and autologous conditioned serum. Any other treatment (sham or active) was considered for comparative studies. Studies were independently reviewed. RESULTS: The literature search yielded 3,063 results, 37 studies were identified for full-text review, and 12 met established inclusion criteria for review. The quality of evidence on effectiveness of intradiscal biologics was very low. A single randomized controlled trial evaluating platelet-rich plasma reported positive outcomes but had significant methodological flaws. A single trial that evaluated mesenchymal stem cells was negative. Success rates for platelet-rich plasma injectate in aggregate were 54.8% (95% Confidence Interval: 40%–70%). For mesenchymal stem cells, the aggregate success rate at six months was 53.5% (95% Confidence Interval: 38.6%–68.4%), though using worst-case analysis this decreased to 40.7% (95% Confidence Interval: 28.1%–53.2%). Similarly, ≥30% functional improvement was achieved in 74.3% (95% Confidence Interval: 59.8%–88.7%) at six months but using worst-case analysis, this decreased to 44.1% (95% Confidence Interval: 28.1%–53.2%). CONCLUSION: Limited observational data support the use of intradiscal biologic agents for the treatment of discogenic low back pain. According to the Grades of Recommendation, Assessment, Development and Evaluation System, the evidence supporting use of intradiscal mesenchymal stem cells and platelet-rich plasma is very low quality.
AB - BACKGROUND CONTEXT: There are limited treatments for discogenic low back pain. Intradiscal injections of biologic agents such as platelet-rich plasma (PRP) or stem cells (SC) are theorized to have regenerative properties and have gained increasing interest as a possible treatment, but the evidence supporting their use in clinical practice is not yet well-defined. PURPOSE: Determine the effectiveness of intradiscal biologics for treating discogenic low back pain. STUDY DESIGN: PRISMA-compliant systematic review. PATIENT SAMPLE: Patients with discogenic low back pain confirmed by provocation discography or clinical and imaging findings consistent with discogenic pain. OUTCOME MEASURES: The primary outcome was the proportion of individuals with ≥50% pain relief after intradiscal biologic injection at 6 months. Secondary outcomes included ≥2-point pain score reduction on NRS; patient satisfaction; functional improvement; decreased use of other health care, including analgesics and surgery; and structural disc changes on MRI. METHODS: Comprehensive literature search performed in 2018 and updated in 2020. Interventions included were biologic therapies including mesenchymal stem cells, platelet rich plasma, microfragmented fat, amniotic membrane-based injectates, and autologous conditioned serum. Any other treatment (sham or active) was considered for comparative studies. Studies were independently reviewed. RESULTS: The literature search yielded 3,063 results, 37 studies were identified for full-text review, and 12 met established inclusion criteria for review. The quality of evidence on effectiveness of intradiscal biologics was very low. A single randomized controlled trial evaluating platelet-rich plasma reported positive outcomes but had significant methodological flaws. A single trial that evaluated mesenchymal stem cells was negative. Success rates for platelet-rich plasma injectate in aggregate were 54.8% (95% Confidence Interval: 40%–70%). For mesenchymal stem cells, the aggregate success rate at six months was 53.5% (95% Confidence Interval: 38.6%–68.4%), though using worst-case analysis this decreased to 40.7% (95% Confidence Interval: 28.1%–53.2%). Similarly, ≥30% functional improvement was achieved in 74.3% (95% Confidence Interval: 59.8%–88.7%) at six months but using worst-case analysis, this decreased to 44.1% (95% Confidence Interval: 28.1%–53.2%). CONCLUSION: Limited observational data support the use of intradiscal biologic agents for the treatment of discogenic low back pain. According to the Grades of Recommendation, Assessment, Development and Evaluation System, the evidence supporting use of intradiscal mesenchymal stem cells and platelet-rich plasma is very low quality.
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U2 - 10.1016/j.spinee.2021.07.015
DO - 10.1016/j.spinee.2021.07.015
M3 - Review article
C2 - 34352363
AN - SCOPUS:85113346498
SN - 1529-9430
VL - 22
SP - 226
EP - 237
JO - Spine Journal
JF - Spine Journal
IS - 2
ER -