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Guideline Summary
Guideline Title
Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain.
Bibliographic Source(s)
Manchikanti L, Boswell MV, Singh V, Benyamin RM, Fellows B, Abdi S, Buenaventura RM, Conn A, Datta S, Derby R, Falco FJ, Erhart S, Diwan S, Hayek SM, Helm S, Parr AT, Schultz DM, Smith HS, Wolfer LR, Hirsch JA. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician 2009 Jul-Aug;12(4):699-802. [1082 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, Sehgal N, Shah RV, Singh V, Benyamin RM, Patel VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL, Bowman RC, Deer TR, Swicegood JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti L. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician 2007 Jan;10(1):7-111. [1334 references] PubMed External Web Site Policy

Jump ToGuideline ClassificationRelated Content

Scope

Disease/Condition(s)

Chronic spinal pain:

  • Neck pain
  • Thoracic pain
  • Low back pain
Guideline Category
Diagnosis
Evaluation
Management
Technology Assessment
Treatment
Clinical Specialty
Anesthesiology
Neurological Surgery
Neurology
Orthopedic Surgery
Physical Medicine and Rehabilitation
Radiology
Rheumatology
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Health Care Providers
Health Plans
Managed Care Organizations
Patients
Physical Therapists
Physician Assistants
Physicians
Utilization Management
Guideline Objective(s)
  • To develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain
  • To provide a set of recommendations that can support existing and future guidelines by:
    • Focusing on a range of interventions that are the essential elements of effective management of chronic spinal pain
    • Providing strategies to manage chronic spinal pain and/or its consequences in the general populations and in workers to improve the quality of clinical care
    • Developing methods that are sound and transparent and highlighting the areas where further research is needed by noting deficiencies in knowledge.
    • Utilizing a process which is valid, reliable, reproducible, clinically applicable, and flexible, providing clarity with a multidisciplinary process with documentation of the process in developing guidelines, along with a scheduled review
    • Providing recommendations that are generally acceptable to a wide range of specialties and agencies
    • Increasing compliance, dispelling misconceptions, contributing to appropriate patient expectations, and facilitating the improved relationship between patients, physicians, and payors
Target Population

All patients with chronic spinal pain who are eligible to undergo commonly utilized and effective interventional technique(s)

Interventions and Practices Considered

Diagnosis/Evaluation (Controlled Diagnostic Interventional Techniques)

  1. Diagnosis of low back pain
    • Lumbar facet or zygapophysial joint blocks
    • Lumbar provocation discography
    • Sacroiliac joint blocks
  2. Diagnosis of neck pain
    • Cervical facet or zygapophysial joint blocks
    • Cervical provocation discography
  3. Diagnosis of thoracic pain
    • Facet or zygapophysial joint blocks
    • Thoracic provocation discography

Treatment/Management (Therapeutic Interventional Techniques)*

  1. Facet joint interventions (intraarticular injections, medial branch blocks, medial branch neurotomy)
  2. Epidural injections (caudal, intralaminar, and transforaminal approaches)
  3. Lumbar epidural adhesiolysis (percutaneous adhesiolysis and spinal endoscopic adhesiolysis)
  4. Sacroiliac joint interventions (intraarticular sacroiliac joint injections and radiofrequency neurotomy)
  5. Intradiscal therapies (intradiscal electrothermal therapy, radiofrequency annuloplasty, and intradiscal biacuplasty)
  6. Percutaneous disc decompression (automated percutaneous lumbar discectomy, percutaneous lumbar laser discectomy, nucleoplasty, mechanical high revolution-per-minute device or Dekompressor)
  7. Spinal cord stimulation
  8. Implantable intrathecal drug administration systems

*Note: Refer to the "Major Recommendations" field of this summary. Some of the interventions carry either a weak or no recommendation because of limitations in the evidence.

Major Outcomes Considered

  • Prevalence of low back pain
  • Validity, specificity, sensitivity of diagnostic interventions
  • Patient-reported pain intensity as recorded with standard pain scales
  • Ability to perform activities of daily living
  • Mood
  • Quality of life
  • Effectiveness of treatment in controlling pain: short-term, long-term pain relief
  • Complications of therapy
  • Cost effectiveness

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

The description of methods used to collect and select the evidence have been described extensively in all systematic reviews (see the "Availability of Companion Documents" field).

For each procedure a comprehensive literature search was conducted from 1966 through December 2008 in the English language. Databases included in the search were Medline, EMBASE, Cochrane Review Database, and Google Scholar. Other sources included Clinical Trial Registry, systematic reviews, narrative reviews, and cross-references to the reviews.

The search strategy emphasized chronic spinal pain with a focus on all types of diagnostic and therapeutic interventions for each procedure. Search terminology included various diagnostic and therapeutic modalities to develop comprehensive search strategy. Inclusion criteria was predetermined for each topic. In general the inclusion criteria strictly adhered to diagnostic validity, outcomes assessment, duration of pain relief, and number of interventions.

All articles retrieved from the search were screened for initial inclusion and exclusion criteria. Methodologic quality assessment was performed using modified Agency for Healthcare Research and Quality (AHRQ) Criteria for diagnostic interventions. For therapeutic interventions Cochrane Review Criteria were utilized along with clinical relevance as described by Cochrane Back Review Group for randomized trials, and AHRQ criteria for observational studies were utilized for non-randomized studies.

All manuscripts were reviewed by at least 2 physicians, any persistent disagreements were reviewed by a third author. Each study had to score at least 50 on a scale of 0 to 100 for inclusion in the analysis. The weighted scoring was established from a consensus developed by the guideline committee of the American Society of Interventional Pain Physicians and has been modified with application in multiple evaluations.

A study was judged to be positive for therapeutic interventions if the interventions were clinically relevant and effective either with a placebo control or active control in randomized trials. Relief of 6 months or less was considered as short-term and relief of longer than 6 months was considered as long-term.

Number of Source Documents

1,400

Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Quality of Evidence Developed by the U.S. Preventive Services Task Force*

I - Evidence obtained from at least one properly randomized controlled trial or multiple properly conducted diagnostic accuracy studies.

II-1: Evidence obtained from one well-designed controlled trial without randomization or at least one properly conducted diagnostic accuracy study of adequate size.

II-2: Evidence obtained from at least one properly designed small diagnostic accuracy study.

II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence.

III: Opinions of respected authorities, based on clinical experience, descriptive studies, and case reports or reports of expert committees.

*Adapted and modified from the U.S. Preventive Services Task Force (USPSTF). Berg AO, Allan JD. Introducing the third U.S. Preventive Services Task Force. Am J Prev Med 2001; 20:S3-S5.

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Level of evidence is derived from quality assessment and the results of individual studies. While there is no universally accepted approach to presenting levels of evidence, a rigorous approach in widespread use was developed by the United States Preventive Services Task Force (USPSTF). "The Rating Scheme for the Strength of the Evidence" field illustrates the modified quality of evidence developed by the USPSTF, utilized in preparation of the present guidelines.

Methodologic quality assessment of systematic reviews is crucial for guideline preparation and grading recommendations. A set of high-performing scales or checklists pertaining to systematic reviews, with 7 key domains, was utilized in the preparation of the present guidelines: study question, search strategy, inclusion and exclusion criteria, data abstraction, study quality and validity, data synthesis and analysis, and funding or sponsorship (see Table 2 in the original guideline document).

Multiple systems are available for the quality assessment and reporting of randomized trials, observational studies, and diagnostic accuracy studies. Various methodologic quality assessment instruments were utilized in the evidence synthesis, preparation of systematic reviews, and preparation of these guidelines.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

The synthesis of evidence, committee composition, and the development process have been revised, refined, and expanded with frequent evaluation.

The translation of systematic reviews into practice recommendations is not straightforward. The same information can be interpreted in different ways by different panelists, resulting in the provision of different guidance. Often, even when there is substantial consensus about what the scientific evidence says, there are disagreements about what the evidence means for clinical practice. Conclusions about clinical effectiveness can vary widely as a result of conflicting viewpoints, such as which outcomes are the most important and which course of action is appropriate given that the evidence is imperfect. Thus, systematic reviews assess the quality of the individual studies and provide the quality and level of evidence. In developing guidelines both are important, that is the quality of evidence and the strength of recommendation which takes into account the balance of the benefits and harms that are associated with the intervention.

The evidence base that supports clinical practice guidelines is often quite limited and guideline developers must often wrestle with what to do when "the irresistible force of the need to offer clinical advice meets with the immovable object of flawed evidence." The authors of guidelines must consider the best way to address the trade-off between rigor and pragmatism, and between adherence to evidence and broader clinical utility. The authors may nonetheless state their evaluation and recommendations based upon the current best available evidence.

Rating Scheme for the Strength of the Recommendations

Grade of Recommendations

Grade of Recommendation/ Description Benefit vs. Risk and Burdens Methodological Quality of Supporting Evidence Implications
1A/strong recommendation, high-quality evidence Benefits clearly outweigh risk and  burdens, or vice versa Randomized controlled trials (RCTs) without important limitations or overwhelming evidence from observational studies Strong recommendation, can apply to most patients in most circumstances without reservation
1B/strong recommendation, moderate quality evidence Benefits clearly outweigh risk and burdens, or vice versa RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies Strong recommendation, can apply to most patients in most circumstances without reservation
1C/strong recommendation, low-quality or very low-quality evidence Benefits clearly outweigh risk and burdens, or vice versa Observational studies or case series Strong recommendation but may change when higher quality evidence becomes available
2A/weak recommendation, high-quality evidence Benefits closely balanced with risks and burden RCTs without important limitations or overwhelming evidence from observational studies Weak recommendation, best action may differ depending on circumstances or patients' or societal values
2B/weak recommendation, moderate-quality evidence Benefits closely balanced with risks and burden RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies Weak recommendation, best action may differ depending on circumstances or patients' or societal values
2C/weak recommendation, low-quality or very low-quality evidence Uncertainty in the estimates of benefits, risks, and burden; benefits, risk, and burden may be closely balanced Observational studies or case series Very weak recommendations; other alternatives may be equally reasonable

Adapted from Guyatt G et al. Grading strength of recommendations and quality of evidence in clinical guidelines. Report from an American College of Chest Physicians task force. Chest 2006; 129:174-181.

Cost Analysis

Published cost analyses were reviewed.  See the original guideline document for each interventional technique in the subsections titled "Cost Effectiveness."

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

Not stated

Recommendations

Major Recommendations

These recommendations are presented in abbreviated form. Readers should refer to the text of the original guideline document for a detailed discussion of each of the following topics.

Definitions for the grades of recommendations (1A/strong, 1B/strong, 1C/strong, 2A/weak, 2B/weak, 2C/weak) and quality of evidence (I, II-1, II-2, II-3, III) are provided at the end of the "Major Recommendations" field.

Controlled Diagnostic Interventional Techniques

Diagnosis of Low Back Pain

Based on the present comprehensive evaluation and other described guidelines (Manchikanti et al., "Comprehensive Review," 2009; 2001, 2002, 2004, 2007, 2008; Sehgal et al., 2005, 2007; Datta et al., 2009; Boswell et al., 2003; Schwarzer et al., 1995; Merskey & Bogduk, "Lumbar zygapophysial joint pain," 1994; Raymond & Dumas, 1984; Bogduk, "Lumbar medical branch blocks," 1997, 2004; Manchukonda et al., 2007; Manchikanti, Hirsch, & Pampati, 2003), diagnostic lumbar facet joint nerve blocks are recommended in patients with suspected facet joint pain.

Indications include:

  • Patients suffering with somatic or non-radicular low back and lower extremity pain, with duration of pain of at least 3 months.
  • Average pain levels are of greater than 6 on a scale of 0 to 10.
  • Pain is at least intermittent or continuous causing functional disability.
  • Condition has failed to respond to more conservative management, including physical therapy modalities with exercises, chiropractic management, and non-steroidal anti-inflammatory agents.
  • Lack of preponderance of evidence of either discogenic or sacroiliac joint pain and lack of disc herniation or evidence of radiculitis.
  • No evidence of contraindications is present for the needle placement and injection of local anesthetics.
  • Presence of contraindications or inability to undergo physical therapy, chiropractic management, or inability to tolerate non-steroidal anti-inflammatory drugs.

A positive response is based on the following evidence:

  • Patient has met the above indications.
  • Patient responds positively to controlled local anesthetic blocks either with placebo control or comparative local anesthetic blocks with appropriate response to each local anesthetic (< 1 mL per level).
  • At least 80% relief as criterion standard with ability to perform previously painful movement without deterioration of the relief (i.e., extension, lateral rotation, flexion, etc.).
  • The patient's response should be recorded independently by the assessor - generally a registered nurse familiar with patient or another physician.

Lumbar Provocation Discography

The recommendations for lumbar provocation discography include appropriate indications with patients with low back pain to prove the diagnostic hypothesis of the discogenic pain specifically after exclusion of other sources of lumbar pain and identification of the disc that should be targeted for treatment, or to establish either that no disc or too many discs are symptomatic, in which case surgery may not be indicated.

Sacroiliac Joint Blocks

Controlled sacroiliac joint blocks with placebo or controlled comparative local anesthetic blocks are recommended when indications are satisfied. A positive response is considered > 80% relief with ability to perform previously painful movements.

  • The primary indication for sacroiliac joint blocks is the need to know if a patient's pain is arising from the sacroiliac joint or not.
  • Sacroiliac joint injections are indicated in patients:
    • With chronic low back pain that is maximal below the level of L5 vertebra extremity
    • With or without somatic referred pain in the lower limb, in whom no other diagnosis is readily apparent
    • No other possible diagnosis is more likely
    • A diagnosis has been made or cannot be made using less invasive options
    • Lack of resolution of pain with the passage of time or conservative therapy

Diagnosis of Neck Pain

Cervical Facet or Zygapophysial Joint Blocks

Based on the present comprehensive evaluation and other described evaluations (Manchikanti et al., "Comprehensive Review," 2009; Sehgal et al., 2005, 2007; Falco et al., 2009; Boswell et al., 2003; Bogduk, 1997; Merskey & Bogduk, "Cervical zygapophysial joint pain," 1994; Bogduk, "Cervical medical branch blocks," 2004), diagnostic cervical facet joint nerve blocks are recommended in patients with the following criteria:

  • Patients suffering with somatic or non-radicular neck pain or headache and upper extremity pain, with duration of pain of at least 3 months.
  • Average pain levels of greater than 6 on a scale of 0 to 10.
  • Pain is at least intermittent or continuous causing functional disability.
  • Problem has failed to respond and has not resolved with more conservative management, including physical therapy modalities with exercises, chiropractic management, and non-steroidal anti-inflammatory agents.
  • Lack of preponderance of evidence of discogenic pain, disc herniation, or evidence of radiculitis.
  • There is no evidence of contraindications for the needle placement and injection of local anesthetics.
  • Contraindications or inability to undergo physical therapy, chiropractic management, or inability to tolerate non-steroidal anti-inflammatory drugs.
  • A positive response is based on the following evidence:
    • Patient has met the above indications.
    • Patient responds positively to controlled local anesthetic blocks either with placebo control or comparative local anesthetic blocks with appropriate response to each local anesthetic with < 1 mL of local anesthetic.
    • At least 80% relief as criterion standard with ability to perform previously painful movement without deterioration of the relief (i.e., extension, overhead activity, lateral rotation, flexion, etc.).
    • The patient's response should be recorded independently by the assessor - generally a registered nurse familiar with patient or another physician.

Cervical Provocation Discography

Based on the systematic review (Manchikanti et al., "Systematic review," 2009), International Association for the Study of Pain (IASP) criteria (Bogduk, "Cervical medical branch blocks," 2004), International Spine Intervention Society (ISIS) criteria (Merskey & Bogduk, "Cervical discogenic pain," 1994), and American Society of Interventional Pain Physicians (ASIPP) criteria (Manchikanti et al., "Comprehensive Review," 2009), the following recommendations are made:

  • Cervical discography is indicated to test the diagnostic hypothesis of discogenic pain of the cervical spine in individuals who have been properly selected and screened to eliminate other sources of cervical pain.
  • The discography should be performed utilizing appropriate criteria and results are considered positive only if the stimulation of the target disc produces concordant pain with an intensity of  at least 7 on a 10-point pain measurement scale or reproduces at least 70% of the most severe pain the patient has experienced (i.e., 5 of 7) and 2 adjacent discs with low volume contrast injection with low pressure discography do not produce any pain at all.

Diagnosis of Thoracic Pain

Facet or Zygapophysial Joint Blocks

Based on the systematic review (Atluri et al., 2008), IASP criteria (Merskey & Bogduk, "Thoracic zygapophysial joint pain," 1994), ISIS criteria (Bogduk, "Thoracic medical branch blocks," 2004), and ASIPP criteria (Manchikanti et al., "Comprehensive Review," 2009) the following recommendations are made.

  • Somatic or nonradicular upper back or mid back pain
  • Duration of pain at least of 3 months
  • Average pain levels of greater than 6 on a scale of 0 to 10
  • Intermittent or continuous pain causing functional disability
  • Failure to respond to more conservative management, including physical therapy modalities with exercises, chiropractic management, and nonsteroidal anti-inflammatory agents
  • Lack of obvious evidence for discogenic pain
  • Lack of disc herniation or evidence of radiculitis
  • No contraindications with understanding of consent, nature of the procedure, needle placement, or sedation
  • No history of allergy to contrast administration, local anesthetics, steroids, Sarapin, or other drugs potentially utilized
  • Contraindications or inability to undergo physical therapy, chiropractic management, or inability to tolerate nonsteroidal anti-inflammatory drugs
  • A positive response is based on the following evidence:
    • Patient has met the above indications.
    • Patient responds positively to controlled local anesthetic blocks either with placebo control or comparative local anesthetic blocks with appropriate response to each local anesthetic with (< 1 mL of local anesthetic) .
    • At least 80% relief as criterion standard with ability to perform previously painful movement without deterioration of the relief (i.e., extension, overhead activity, lateral rotation, flexion, etc.).
    • The patient's response should be recorded independently by the assessor - generally a registered nurse familiar with patient or another physician.

Thoracic Provocation Discography

The recommendations based on IASP criteria (Merskey & Bogduk, "Thoracic zygapophysial joint pain," 1994), ISIS criteria (Bogduk, "Thoracic provocation discography," 2004), and ASIPP criteria (Manchikanti et al., "Comprehensive Review," 2009) are as follows:

  • The thoracic discography is indicated to decide if an intervertebral disc is painful or not.
  • The discography should be performed utilizing appropriate criteria and results are considered positive only if the stimulation of the target disc produces concordant pain with an intensity of at least 7 on a 10-point pain measurement scale or reproduces at least 70% of the most severe pain the patient has experienced (i.e., 5 of 7) and 2 adjacent discs with low volume contrast injection with low pressure provocation discography do not produce any pain at all.

Therapeutic Interventional Techniques

Facet Joint Interventions

Based on the available evidence, therapeutic intraarticular facet joint injections are not recommended.

Medial Branch Blocks

Based on Guyatt et al.'s criteria (Guyatt et al., 2006) the recommendation is strong (1B or 1C) for the use of therapeutic cervical, thoracic, and lumbar facet joint nerve blocks to provide both short-term and long-term relief in the treatment of chronic facet joint pain.

Medial Branch Neurotomy

Based on Guyatt et al.'s, (2006) criteria for cervical radiofrequency neurotomy and lumbar radiofrequency neurotomy, the recommendation is 1C/strong recommendation.

Epidural Injections

Caudal Epidural Injections

Based on grading recommendations by Guyatt et al. (2006), the recommendation for caudal epidural steroid injections is as follows:

  • In managing lumbar spinal pain with disc herniation and radiculitis or discogenic pain without disc herniation or radiculitis, the recommendation is 1A or 1B/strong.
  • The recommendation for caudal epidural injections in managing patients with post-lumbar laminectomy syndrome and spinal stenosis is 1B or 1C/strong.

Interlaminar Epidural Injections

Cervical Intralaminar Injections

Based on Guyatt et al.'s criteria (2006), the recommendation for cervical interlaminar epidurals is 1C/strong.

The recommendation for disc herniation and radiculitis for blind lumbar interlaminar epidural injections is 1C, a strong recommendation which may change when higher quality evidence becomes available for short-term relief. However, for long-term relief, the recommendation is 2B, with weak recommendation, with best action differing depending on circumstances or patients' or societal values. For spinal stenosis and discogenic pain without disc herniation and radiculitis, the recommendation is 2C/very weak.

Lumbar Transforaminal Epidural Injections

Based on the criteria by Guyatt et al. (2006), the recommendation for lumbar transforaminal epidural injections, in managing chronic low back and lower extremity pain, is 1C/strong recommendation.

Lumbar Epidural Adhesiolysis

Percutaneous Adhesiolysis

The recommendation is strong, with 1B or 1C for percutaneous adhesiolysis in post lumbar surgery syndrome.

Spinal Endoscopic Adhesiolysis

Based on Guyatt et al.'s (2006) grading strength of recommendations and quality of evidence in clinical guidelines, the recommendation is 1C/strong for endoscopic adhesiolysis in post lumbar laminectomy syndrome.

Sacroiliac Joint Interventions

Intraarticular Sacroiliac Joint Injections

Based on the available literature and evidence no recommendation is provided.

Radiofrequency Neurotomy

The recommendations based on Guyatt et al.'s (2006) criteria is 2B, a weak recommendation for radiofrequency neurotomy for sacroiliac joint pain.

Intradiscal Therapies

Intradiscal Electrothermal Therapy

A recommendation of 2A/weak recommendation is provided based on Guyatt et al.'s (2006) recommendation.

Intradiscal Biacuplasty

No recommendation is provided based on the available evidence.

Radiofrequency Posterior Annuloplasty

No recommendation is provided.

Percutaneous Disc Decompression

Automated Percutaneous Lumbar Discectomy (APLD)

The recommendation is 1C/strong recommendation based on Guyatt et al.'s (2006) criteria.

Percutaneous Lumbar Laser Discectomy (PLLD)

The recommendation based on Guyatt et al.'s (2006) criteria is 1C/strong recommendation for PLLD.

Nucleoplasty

The recommendation based on Guyatt et al.'s (2006) criteria is 2B/weak recommendation in managing radicular pain due to contained disc herniation. No recommendation is available in managing axial low back pain.

Mechanical High RPM Device

No recommendation is provided for Dekompressor.

Spinal Cord Stimulation

Based on Guyatt et al.'s (2006) criteria, the recommendation is 1B or 1C/strong recommendation for clinical use on a long-term basis.

Implantable Intrathecal Drug Administration Systems

Based on Guyatt et al.'s (2006) criteria, the recommendation for intrathecal infusion systems is 1C/strong, with proper selection criteria.

Definitions:

Quality of Evidence*

I - Evidence obtained from at least one properly randomized controlled trial or multiple properly conducted diagnostic accuracy studies.

II-1: Evidence obtained from one well-designed controlled trial without randomization or at least one properly conducted diagnostic accuracy study of adequate size.

II-2: Evidence obtained from at least one properly designed small diagnostic accuracy study.

II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence.

III: Opinions of respected authorities, based on clinical experience, descriptive studies, and case reports or reports of expert committees.

*Adapted and modified from the U.S. Preventive Services Task Force (USPSTF). Berg AO, Allan JD. Introducing the third U.S. Preventive Services Task Force. Am J Prev Med 2001; 20:S3-S5.

Grade of Recommendations

Grade of Recommendation/ Description Benefit vs. Risk and Burdens Methodological Quality of Supporting Evidence Implications
1A/strong recommendation, high-quality evidence Benefits clearly outweigh risk and burdens, or vice versa Randomized controlled trials (RCTs) without important limitations or overwhelming evidence from observational studies Strong recommendation, can apply to most patients in most circumstances without reservation
1B/strong recommendation, moderate quality evidence Benefits clearly outweigh risk and burdens, or vice versa RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies Strong recommendation, can apply to most patients in most circumstances without reservation
1C/strong recommendation, low-quality or very low-quality evidence Benefits clearly outweigh risk and burdens, or vice versa Observational studies or case series Strong recommendation but may change when higher quality evidence becomes available
2A/weak recommendation, high-quality evidence Benefits closely balanced with risks and burden RCTs without important limitations or overwhelming evidence from observational studies Weak recommendation, best action may differ depending on circumstances or patients' or societal values
2B/weak recommendation, moderate-quality evidence Benefits closely balanced with risks and burden RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies Weak recommendation, best action may differ depending on circumstances or patients' or societal values
2C/weak recommendation, low-quality or very low-quality evidence Uncertainty in the estimates of benefits, risks, and burden; benefits, risk, and burden may be closely balanced Observational studies or case series Very weak recommendations; other alternatives may be equally reasonable

Adapted from Guyatt G et al. Grading strength of recommendations and quality of evidence in clinical guidelines. Report from an American College of Chest Physicians task force. Chest 2006; 129:174-181.

Clinical Algorithm(s)

The original guideline document contains the following algorithms:

  • A comprehensive algorithm evaluation and management of chronic spinal pain
  • An algorithmic approach to diagnosis of chronic low back pain without disc herniation
  • A suggested algorithm for therapeutic interventional techniques in management of chronic low back pain
  • An algorithmic approach to diagnosis of chronic neck pain without disc herniation
  • A suggested algorithm for therapeutic interventional techniques in the management of chronic neck pain
  • An algorithmic approach to diagnosis of chronic thoracic pain without disc herniation or radiculitis
  • A suggested algorithm for therapeutic interventional techniques in the management of chronic thoracic pain

Evidence Supporting the Recommendations

References Supporting the Recommendations
Type of Evidence Supporting the Recommendations

The level of evidence for each intervention is provided in the original guideline document in the subsections titled "Level of Evidence."  The following is a summary of the indicated evidence for selected recommended interventions:

The indicated evidence for accuracy of diagnostic facet joint nerve blocks is Level I or II-1 in the diagnosis of lumbar, thoracic, and cervical facet joint pain. The evidence for lumbar and cervical provocation discography and sacroiliac joint injections is Level II-2, whereas it is Level II-3 for thoracic provocation discography.

The indicated evidence for therapeutic interventions is Level I for caudal epidural steroid injections in managing disc herniation or radiculitis, and discogenic pain without disc herniation or radiculitis. The evidence is Level II-1 or II-2 for therapeutic cervical, thoracic, and lumbar facet joint nerve blocks; for caudal epidural injections in managing pain of post-lumbar surgery syndrome, and lumbar spinal stenosis, for cervical interlaminar epidural injections in managing cervical pain; for lumbar transforaminal epidural injections; for percutaneous adhesiolysis in management of pain secondary to post-lumbar surgery syndrome; and spinal cord stimulation for post-lumbar surgery syndrome. The indicated evidence for intradiscal electrothermal therapy (IDET), mechanical disc decompression with automated percutaneous lumbar discectomy (APLD), and percutaneous lumbar laser discectomy (PLDD) is Level II-2.

Definitions for the levels of evidence can be found at the end of the "Major Recommendations" field.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Implementation of the guidelines may improve the quality of care, patient access, treatment outcomes, appropriateness of care, efficiency and effectiveness, and achieve cost containment by improving the cost-benefit ratio.

Potential Harms

Complications from diagnostic and therapeutic interventions are described in the original guideline document in the sections titled "Complications" or "Safety and Complications" for each intervention. Complications, in general, are related to needle placement and drug administration.

Contraindications

Contraindications

In general, contraindications include inability to undergo or tolerate recommended interventional procedures and/or associated drug therapies.

Qualifying Statements

Qualifying Statements
  • The limitations of these guidelines include a continued paucity of the literature, lack of updates, and conflicts in preparation of systematic reviews and guidelines by various organizations.
  • These guidelines are intended for use by interventional pain physicians and other physicians trained in interventional pain management. However, these guidelines do not constitute inflexible treatment recommendations. It is expected that a provider will establish a plan of care on a case-by-case basis, taking into account an individual patient's medical condition, personal needs, and preferences, and the physician's experience. Based on an individual patient's needs, treatment different from that outlined here could be warranted. These guidelines do not represent a "standard of care."
  • The goal of these guidelines is to provide patients, practitioners, regulators, and payors information to determine whether the available evidence supports the notion of a "standard" for interventional techniques. "Standard" refers to what is applicable to the majority of patients, with a preference for patient convenience and ease of administration without compromising the treatment efficacy or morbidity. It is essential to recognize the difference between "standard" and "standard of care," as utilized by a legal definition.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Clinical Algorithm
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Manchikanti L, Boswell MV, Singh V, Benyamin RM, Fellows B, Abdi S, Buenaventura RM, Conn A, Datta S, Derby R, Falco FJ, Erhart S, Diwan S, Hayek SM, Helm S, Parr AT, Schultz DM, Smith HS, Wolfer LR, Hirsch JA. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician 2009 Jul-Aug;12(4):699-802. [1082 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2003 (revised 2009 Jul-Aug)
Guideline Developer(s)
American Society of Interventional Pain Physicians - Medical Specialty Society
Guideline Developer Comment

The authors are solely responsible for the content of this article. No statement in this article should be construed as an official position of American Society of Interventional Pain Physicians (ASIPP).

Source(s) of Funding

American Society of Interventional Pain Physicians

Guideline Committee

Research and Guideline Committee

Composition of Group That Authored the Guideline

Primary Authors: Laxmaiah Manchikanti, MD, Medical Director of the Pain Management Center of Paducah, Paducah, KY; Mark V. Boswell, MD, PhD, Chairman of Department of Anesthesiology and  Director of the International Pain Center, Texas Tech University Health Sciences Center, Lubbock, TX; Vijay Singh, MD, Medical Director of Pain Diagnostics Associates, Niagara, WI; Ramsin M. Benyamin, MD, Medical Director, Millennium Pain Center, Clinical Associate Professor, Department of Surgery, College of Medicine, University of Illinois, Urbana-Champaign, IL; Bert Fellows, MA, Director Emeritus of Psychological Services at the Pain Management Center of Paducah, Paducah, KY; Salahadin Abdi, MD, PhD, Professor and Chief, Division of Pain Medicine, Department of Anesthesiology, Perioperative Medicine and Pain Management, University of Miami, Miller School of Medicine, Miami, FL; Ricardo M. Buenaventura, Medical Director, Pain Relief of Dayton, Centerville, OH, and Clinical Associate Professor, Department of Surgery, Wright State University School of Medicine, Dayton, OH; Ann Conn, MD, staff physician, Premier Pain Relief, Covington, LA; Sukdeb Datta, MD, Director, Vanderbilt University Interventional Pain Program, Associate Professor, Dept. of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN; Richard Derby, MD, Medical Director of Spinal Diagnostics & Treatment Center, Daly City, CA, and Associate Professor, Department of Physical Medicine and Rehabilitation, Stanford University, Stanford, CA; Frank JE Falco, MD, Medical Director of the Mid Atlantic Spine & Pain Specialists of Newark, DE, and Clinical Assistant Professor, Temple University Medical School, Philadelphia, PA; Stephanie Erhart, MLIS, Educational/Research Coordinator, Librarian for Mid Atlantic Spine & Pain Specialists of Newark, DE; Sudhir Diwan, MD, Director of Pain Medicine in the Department of Anesthesiology, New York Presbyterian Hospital, and the Director of the Tri-Institutional Pain Fellowship Program, Weill Cornell Medical College, New York, NY; Salim M. Hayek, MD, PhD, Chief of the Division of Pain Medicine, Department of Anesthesiology, University Hospitals of Cleveland, Cleveland, OH, and a member of the Outcomes Research Consortium, Cleveland, OH; Standiford Helm II, MD, Medical Director, Pacific Coast Pain Management Center, Laguna Hills, CA; Allan T. Parr, MD, Medical Director of Premier Pain Center, Covington, LA; David M. Schultz, MD, Medical Director and President of Medical Advanced Pain Specialists, Minneapolis, MN; Howard S. Smith, MD, Associate Professor and Academic Director of Pain Management for Albany Medical College Department of Anesthesiology, Albany, NY; Lee R. Wolfer, MD, MS, is with the Spinal Diagnostics & Treatment Center, Daly City, CA; Joshua A. Hirsch, MD, Chief of Minimally Invasive Spine Surgery, Depts. of  Radiology and Neurosurgery, Massachusetts General Hospital and Assistant Professor of Radiology, Harvard Medical School, Boston, MA; Dr. Manchikanti, Dr. Singh, Dr. Benyamin, Dr. Abdi, Dr. Datta, Dr. Falco, Dr. Helm, Dr. Parr, Dr. Shah, Dr. Schultz, and Dr. Hirsch are members of the American Society of Interventional Pain Physicians board of directors.

Financial Disclosures/Conflicts of Interest

Conflicts of interest:

  • Dr. Datta receives research support from Sucampo Pharmaceuticals and an honorarium from Smith and Nephew.
  • Dr. Schultz is a paid consultant for Medtronic.
  • Dr. Hayek is a consultant for Boston Scientific, Valencia, CA.
  • Dr. Hirsch is a consultant for Cardinal Healthcare and Medtronic, he has previously served as a consultant for Arthrocare, he serves on the Steering Committee for KAVIAR trial (volunteer position), and on the Data and Safety Monitoring Board (DSMB): CEEP trial (volunteer position).
  • Dr. Derby has stock options with Laurimed and Kyphon.
Guideline Endorser(s)
Society of Interventional Pain Management Surgery Centers - Hospital/Medical Center
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, Sehgal N, Shah RV, Singh V, Benyamin RM, Patel VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL, Bowman RC, Deer TR, Swicegood JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti L. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician 2007 Jan;10(1):7-111. [1334 references] PubMed External Web Site Policy

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the American Society of Interventional Pain Physicians Web site External Web Site Policy.

Print copies: Available from the American Society of Interventional Pain Physicians, 2831 Lone Oak Road, Paducah, KY 42003; Phone: (270) 554-9412; Fax: (270) 554-8987; email: asipp@asipp.org.

Availability of Companion Documents

The following are available:

  • Manchikanti L, Singh V, Helm S, Schultz DM, Datta S, Hirsch JA. An introduction to an evidence-based approach to interventional techniques in the management of chronic spinal pain. Pain Physician 2009;12:E1-E33. Electronic copies: Available in Portable Document Format (PDF) from the American Society of Interventional Pain Physicians Web site External Web Site Policy.
  • Manchikanti L, Singh V, Datta S, Cohen SP, Hirsch JA. Comprehensive review of epidemiology, scope, and impact of spinal pain. Pain Physician 2009;12:E35-E70. Electronic copies: Available in Portable Document Format (PDF) from the American Society of Interventional Pain Physicians Web site External Web Site Policy.
  • Manchikanti L, Boswell, MV, Singh V, Derby R, Fellows B, Falco FJ, Datta S, Smith HS, Hirsch JA. Comprehensive review of neurophysiologic basis and diagnostic interventions in managing chronic spinal pain. Pain Physician 2009;12:E71-E121. Electronic copies: Available in Portable Document Format (PDF) from the American Society of Interventional Pain Physicians Web site External Web Site Policy.
  • Manchikanti L, Boswell MV, Datta S, Fellows B, Abdi S, Singh V, Benyamin RM, Falco FJ, Helm S, Hayek SM, Smith HS. Comprehensive review of therapeutic interventions in managing chronic spinal pain.  Pain Physician 2009;12:E123-E198. Electronic copies: Available in Portable Document Format (PDF) from the American Society of Interventional Pain Physicians Web site External Web Site Policy.
  • Manchikanti L, Singh V, Pampati V, Boswell MV, Benyamin RM, Hirsch JA. Description of documentation in the management of chronic spinal pain. Pain Physician 2009;12:E199-E224. Electronic copies: Available in Portable Document Format (PDF) from the American Society of Interventional Pain Physicians Web site. External Web Site Policy
  • Manchikanti L, Helm S, Singh V, Benyamin RM, Datta S, Hayek SM, Fellows B, Boswell MV. An algorithmic approach for clinical management of chronic spinal pain. Pain Physician 2009;12:E225-E264. Electronic copies: Available in Portable Document Format (PDF) from the American Society of Interventional Pain Physicians Web site External Web Site Policy.

Print copies: Available from the American Society of Interventional Pain Physicians, 2831 Lone Oak Road, Paducah, KY 42003; Phone: (270) 554-9412; Fax: (270) 554-8987; email: asipp@asipp.org.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on July 21, 2003. The information was verified by the guideline developer on July 31, 2003. This NGC summary was updated by ECRI Institute on May 16, 2005. The information was verified by the guideline developer on June 6, 2005. This NGC summary was updated by ECRI Institute on April 18, 2007. The information was verified by the guideline developer on May 7, 2007. The summary was updated by ECRI Institute on January 28, 2010. The information was verified by the guideline developer on February 11, 2010.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. This guideline is available for download from the American Society of Interventional Pain Physicians (ASIPP) Web site External Web Site Policy.

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