Last updated March 14, 2022

Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain

Summary of Evidence

Lumbar Disc Injections:

Based on the available evidence regarding the use of platelet-rich plasma (PRP), including one high-quality randomized controlled trial (RCT), multiple moderate-quality observational studies, a single-arm meta-analysis and evidence from a systematic review, the qualitative evidence has been assessed as Level III (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best-evidence synthesis. (III, )
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Based on the available evidence regarding the use of medicinal signaling/ mesenchymal stem cell (MSCs) with a high-quality RCT, multiple moderate-quality observational studies, a single-arm meta-analysis, and 2 systematic reviews, the qualitative evidence has been assessed as Level III (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence-based on best evidence synthesis. (III, )
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Lumbar Epidural Injections:

Based on one high-quality RCT, multiple relevant moderate-quality observational studies and a single-arm meta-analysis, the qualitative evidence has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. (IV, )
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Lumbar Facet Joint Injections

Based on one high-quality RCT and 2 moderate-quality observational studies, the qualitative evidence for facet joint injections with PRP has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. (IV, )
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Sacroiliac Joint Injection:

Based on one high-quality RCT, one moderate-quality observational study, and one low-quality case report, the qualitative evidence has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. (IV, )
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Recommendation Grading

Overview

Title

Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain

Authoring Organization

Publication Month/Year

February 1, 2019

Supplemental Implementation Tools

Video, Video, Video, Video

Document Type

Guideline

External Publication Status

Published

Country of Publication

US

Document Objectives

To provide guidance for the responsible, safe, and effective use of biologic therapy in the lumbar spine. To present a template on which to build standardized therapies using biologics. To ground potential administrators of biologics in the knowledge of the current outcome statistics and to stimulate those interested in providing biologic therapy to participate in high quality research that will ultimately promote and further advance this area of medicine.

Target Patient Population

Patients with low back pain

Inclusion Criteria

Female, Male, Adolescent, Adult, Older adult

Health Care Settings

Ambulatory, Hospital, Long term care, Outpatient

Scope

Treatment

Diseases/Conditions (MeSH)

D059350 - Chronic Pain, D001416 - Back Pain, D044968 - Regenerative Medicine, D058630 - Spinal Cord Regeneration

Keywords

biologics, chronic pain

Source Citation

Pain Physician: Guidelines Issue 2019; 22:S1-S74

Supplemental Methodology Resources

Systematic Review Document

Methodology

Number of Source Documents
353
Literature Search Start Date
January 1, 1966
Literature Search End Date
June 30, 2018
Description of External Review Process
Journal Peer Review Process
Specialties Involved
Family Medicine, Internal Medicine General, Orthopaedic Surgery, Pain Medicine
Description of Systematic Review
Data sources included PubMed, Cochrane Library, U.S. Agency for Healthcare Research and Quality's National Guideline Clearinghouse (NGC), prior systematic reviews, and reference lists, Clinical Trials, and all other sources including non-indexed journals and abstracts. The literature search was performed from 1966 through June 2018. Search criteria were extensive, covering chronic low back pain of various origins along with multiple methods of injection of biologicals including PRP and stem cells. Refer to the systematic review (Do Regenerative Medicine Therapies Provide Long-Term Relief in Chronic Low Back Pain: A Systematic Review and Metaanalysis [see the "Supporting Documents" field]) for the full search strategy.
List of Questions
See full text.
Description of Study Criteria
See appendix
Description of Search Strategy
Data sources included PubMed, Cochrane Library, U.S. Agency for Healthcare Research and Quality's National Guideline Clearinghouse (NGC), prior systematic reviews, and reference lists, Clinical Trials, and all other sources including non-indexed journals and abstracts. The literature search was performed from 1966 through June 2018. Search criteria were extensive, covering chronic low back pain of various origins along with multiple methods of injection of biologicals including PRP and stem cells. Refer to the systematic review (Do Regenerative Medicine Therapies Provide Long-Term Relief in Chronic Low Back Pain: A Systematic Review and Metaanalysis [see the "Supporting Documents" field]) for the full search strategy.
Description of Study Selection
The study selection included randomized controlled trials (RCTs), observational studies (sample size of at least ten subjects), and case reports of injections of biologics into the disc, epidural space, facet joints, or sacroiliac joints. All available trials in all languages, from all countries, providing appropriate management with outcome evaluations were considered for inclusion. Book chapters, case reports, and reports without an appropriate diagnosis were excluded from consideration. This review focused only on studies of effectiveness. The population of interest was patients suffering from chronic low back pain. Patients with acute trauma, fractures, malignancies, and inflammatory diseases were excluded. Refer to Figure 1 in the systematic review for a flow diagram of the study selection using the PRISMA study selection process. Based on the search criteria, 26 manuscripts were identified and considered for inclusion. Of the 21 manuscripts meeting inclusion criteria, 5 were randomized trials.
Description of Evidence Analysis Methods
Data synthesis and analysis were performed, including assessment of the risk of bias or quality of individual studies, outcomes assessment, and qualitative and quantitative analysis. The quality of each individual article used in this analysis was assessed using the Cochrane Review rating system (refer to Appendix Table 1 in the systematic review) and lnterventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment Tool (1PM - QRB) for randomized controlled trials (refer to Appendix Table 2 in the systematic review), and lnterventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment for nonrandomized or observational studies (IPM-QRBNR) (refer to Appendix Table 3 in the systematic review). Methodologic quality assessment of each manuscript was performed by 2 review authors. The assessment was carried out independently in an unblinded, standardized manner to assess the methodologic quality and internal validity of all the studies considered for inclusion. If discrepancies occurred, a third reviewer performed an assessment, and a consensus was reached. Further remaining issues were discussed by all reviewers and were then resolved.
Description of Evidence Grading
ASIPP use Levels of Evidence I-V. The analysis of the evidence was performed based on best-evidence synthesis and was modified and collated using multiple available criteria, including the Cochrane Review criteria and U.S. Preventive Task Force (USPSTF) criteria as illustrated in Table 1 of the systematic review. The analysis was conducted using 5 levels of evidence ranging from strong to opinion- or consensus-based. The results of best evidence as per grading were utilized. At least 2 of the review authors independently, in an unblinded, standardized manner, analyzed the evidence. Any disagreements between reviewers were resolved by a third author and consensus was attained. If there were any conflicts of interest (e.g., authorship), the reviewers of interest were recused from assessment and analysis.
Description of Recommendation Grading
The grading of evidence is based on RCTs, observational studies, and other clinical reports. In addition, systematic reviews and meta-analyses were utilized. The grading of evidence based on ASIPP guidelines is shown in Table 1 of the original guideline. This grading system specifies levels of scientific evidence and offers an approach to grading the quality of evidence and secondarily the strength of recommendations.
Description of Funding Source
ASIPP funds Guideline Development. There is no external funding in preparation of this manuscript.
Company/Author Disclosures
Potential COis for all panel members within the last 5 years were evaluated prior to the finalizing of these guidelines. COis extended beyond financial relationships, including personal experience, practice patterns, academic interests, and promotions. Participants with previously established conflicts are considered those with opinions not being in line with previously developed ASIPP guidelines or the overall philosophical approach of ASIPP. The panel members with potential conflicts were recused from discussion or preparation of the guidelines in which they had COis, and these members agreed not to discuss any aspect of a given guideline with the related industry before data publication.
Percentage of Authors Reporting COI
100