I.       Preamble

The PCCRP Guidelines contained herein are evidence-based suggestions for appropriate radiographic evaluations of patients seeking chiropractic care. No guideline can replace the clinical decisions made by a chiropractic practitioner in the course of treating an individual patient’s health problem. Any approach, by a practitioner, that is different from the PCCRP Guidelines, does not necessarily mean that the approach in question was below the standard of care. However, any chiropractic practitioner, who adopts a course of action different from the PCCRP Guidelines, is advised to keep sufficient patient records to explain why such an action was undertaken.

            Chiropractic is a philosophy, a science, and an art. From the state of any science (science is constantly evolving), the variety, complexity, severity, and intricacy of human health conditions create an environment where it is impossible to always have the appropriate examination, the appropriate radiographic analysis, and to predict with certainty the patient’s response to chiropractic spinal care. Therefore, adherence to these PCCRP Guidelines will not always insure that an accurate assessment of the patient’s spinal health has occurred. By following the PCCRP Guidelines, it is expected that the chiropractic practitioner will follow a reasonable course of action based on the best available knowledge. It is expected that with the assistance of the PCCRP Guidelines, the chiropractic practitioner will use the assessment of spinal subluxation suggested herein to deliver safe and effective chiropractic care.

II.      Purpose/Aims, Clinical Questions, Patient Population, Intended Users

          The purposes of these PCCRP Radiology Protocols are to (1) locate and rate the evidence for “Biomechanical Assessment of Spinal Subluxation in Chiropractic Clinical Practice Using Radiography” and (2) assist the practicing Chiropractor in making sound, fundamental clinical decisions when using radiology in clinical practice.

            The aims of these Guidelines are nine-fold:

1.         To provide evidence from the literature, identifying if the routine use of radiography in chiropractic practice, as mandated by State and Provincial laws, is valid practice,

2.         To determine the health risk of spinal radiography use (see Section on Hormesis),

3.         To identify the radiographic views utilized in most Chiropractic Technique systems,

4.         To determine the clinical utility of common radiographic views for Chiropractic clinical practice,

5.         To determine the reliability, validity, and efficacy of common radiological views utilized in chiropractic clinical practice,

6.         To identify, with evidence, if the routine use of radiography in pediatric cases is valid,

7.         To define chiropractic spinal subluxation from a structural/displacement view point and provide spinal radiographic normal values for alignment,

8.         To review spinal radiographic guidelines from other professions, and

9.         To provide Chiropractic College Instructors with the actual, updated, evidence on x-ray usage in Chiropractic clinical practice, in order that the current information be shared with prospective chiropractors.

                  Besides patients with headache, neck pain, thoracic pain, and low back pain, patients, who have been medical failures’ with a variety of diseases and structural abnormalities, seek chiropractic care. For all these prospective patients, these PCCRP Guidelines outline the state of evidence for x-ray utilization in Chiropractic clinical practice.

            Since a wide variety of suffering patients seek chiropractic care, and since chiropractic has a historical structural basis, the evaluation of spinal health, spinal degeneration, structural alignment, spinal balance, and how these affect health are among the clinical questions answered in this document.

            These PCCRP Guidelines are intended to support the clinical decisions made by Practicing Chiropractors, not only in the USA and Canada, but in the world at large.

 

III.    X-ray Protocols/Guidelines

          While the whole document is the supporting evidence for routine radiographic examinations in clinical practice, in Section II, a list of Indications is actually the Guidelines (listed as “Indications for Spine Radiography in Children and Adults”).  These Guidelines”/”Indications” for spine radiographic examinations include, but are not limited to:

1.                  Abnormal posture

2.                  Spinal Subluxation (as defined in this document)

3.                  Spinal deformity (eg, scoliosis, hyper-kyphosis, hypo-kyphosis)

4.                  Trauma, especially trauma to the spine

5.                  Birth Trauma (eg, forceps, etc…)

6.                  Restricted or abnormal motion

7.                  Abnormal gait

8.                  Axial pain

9.                  Radiating pain (eg, upper extremity, intercostal, lower extremity)

10.              Headache

11.              Suspected short leg

12.              Suspected spinal instability

13.              Follow-up for previous deformity, previous abnormal posture, previous spinal subluxation/displacement, previous spinal instability

14.              Suspected osteoporosis

15.              Facial pain

16.              Systemic health problems (eg, skin diseases, asthma, auto-immune diseases, organ dysfunction )

17.              Neurological conditions

18.              Delayed developmental conditions

19.              Eye and vision problems other than corrective lenses

20.              Hearing disorders, vertigo, tinnitus

21.              Spasm, inflammation, or tenderness

22.              Suspected abnormal pelvic morphology

23.              Post surgical evaluation

24.              Suspected spinal degeneration/arthritis

25.              Suspected Congenital anomaly

26.              Pain upon spinal movement

27.              Any “Red Flag Conditions” covered in previous guidelines.

 IV.     Guideline Development and Evaluation Process

 A. Systematic Literature Search of Publications for the PCCRP Guidelines

1. Search Indices/Engines Used for Data Collection:     The Chiropractic, Orthopedic, Physical medicine, Osteopathic and Manual Medicine fields were searched using the following citation indices:

1. Pub Med through Medline
2. MANTIS http://www.healthindex.com/ ,
3. The Index to Chiropractic literature http://www.chiroindex.org/#results ,
4. Google’s beta version of their “scientific” search engine available for free use: http://www.scholar.google.com ,
5. Chiropractic and Orthopedic, and Radiology texts,
6. Chiropractic technique texts.

2.  Search Topics and Key Word Search

The search topics included the following:

1. Radiography guidelines for spinal conditions.
2. Radiation Hormesis, exposure levels, and health risks of radiation.
3. Presence of pain as an indicator for spinal radiography.

1) Which anatomical structures does the pain arise from?

a)      Disc.

b)      Facet joint & capsule.

c)      Other spinal ligaments.

d)      Muscles.

2)   Possible causes of pain?

a.       Chemical irritation.

b.      Abnormal mechanical loads on the spinal tissue.

3)   Possible causes of abnormal loads on the spinal tissues?

a.       Posture rotations & translations with spinal coupling.

b.      Sagittal buckling (snap through).

c.       AP buckling- Euler buckling.

d.      Segmental subluxations (retro, spondy, laterolisthesis).

4. Definitions for spinal subluxation in Chiropractic:

1)   Key Words: Chiropractic, Subluxation Definitions, Subluxation Theories, Subluxation Categories, Spinal Lesion, Spinal Disfunction, and Vertebral Subluxation.

5. X-ray views and procedures of the spine utilized in Chiropractic Practice:

1)   Key Words: X-ray and Chiropractic, Radiography and Chiropractic, Chiropractic Technique and Radiography, Chiropractic Technique and X-ray, Spinal Subluxation and Chiropractic, Vertebral Subluxation and X-ray, Spinography, Video Flouoroscopy, Dynamic X-ray, Stress Radiography, Stress X-ray.

6. Reliability of X-ray measurement methods for spinal position:

1)   Key Words: X-ray and Reliability, Radiography and Reliability, X-ray, Spine, and Measurement, Radiography and Measurement, Radiograph, Chiropractic Technique, Radiographic Analysis.

7. Reliability/repeatability of X-ray positioning procedures of patients:

1)   Key Words: Reliability, Repeatability, Posture, Spine Position Sense, Spine Position, Radiograph, Chiropractic Technique, Radiographic Analysis.

8. Predictive Validity of spinal displacements ascertained in different radiographic views:

1)   Key Words: Model, Radiographic Analysis, Normal Values, Neck Pain, Low Back Pain, Lordosis, Kyphosis, Cervical Spine, Lumbar Spine, Thoracic Spine.

9. Chiropractic, Physical Medicine, Osteopathic, Manual Medicine treatment outcome studies on spinal displacements verified by way of x-rays. Treatment method must be a known treatment as used in Chiropractic clinicalpPractice and treatment must be used to reduce/correct spinal displacements on x-ray:

1)   Key Words: Chiropractic Technique, Spinal Subluxation, Vertebral Subluxation, X-ray, Radiography, Radiograph.

 B.  Study Inclusion Criteria for Guideline Analysis and Production:

  Studies were included if they fit the following criteria under each specific topic:

1.      X-ray views of the spine utilized in Chiropractic Practice:

1)   Any technique system or chiropractic technique text book or Chiropractic radiography text book describes the use of this view for analysis and measurement of spinal position or alignment.

10. Reliability of X-ray measurement methods for spinal position:

1)   Study must have utilized a repeated measures design with at least one examiner measuring spinal position on a set of spinal x-rays at least twice.

2)   Study must have reported a minimum of one of the following statistical analyses: standard error of measurement (SEM) or standard error of the mean, mean absolute value of observer(s) differences, intraclass correlation coefficients, interclass correlation coefficients, Pearson’s r value, Kappa coefficients.

11. Reliability/repeatability of X-ray positioning procedures of patients:

1)   Study must have utilized a repeated measures design with at least one examiner ascertaining a spinal positional x-ray on a set of subjects at least twice.

2)   Study must have reported a minimum of one of the following statistical analyses: standard error of measurement (SEM) or standard error of the mean, mean absolute value of observer(s) differences, intraclass correlation coefficients, interclass correlation coefficients, Pearson’s r value, Kappa coefficients.

12. Predictive validity of spinal displacements ascertained in different radiographic views:

1)   Study must have ascertained spinal x-rays of any patient population that is specified as one of the following: Normal, Low back pain, Neck pain, Thoracic Pain, or other physical conditions related to the spine such as sciatica, disc degeneration, organ injury, health status, etc...

2)   Study must have made measurements of spinal position using a reliable, radiographic procedure as outlined in #2 above.

3)   Study must have made comparison of spinal alignment data from x-ray of healthy populations to spinal alignment data in ‘condition specific’ population.

4)   If the study only utilized 1 group of subjects (low back pain, etc...), 1) study must have made an attempt to compare their data to data in other studies on other types of groups or 2) study must have attempted to break their subjects into severity of condition to look at spinal alignment correlations between these subject subsets.

13. Chiropractic, Physical Medicine, Osteopathic, Manual Medicine treatment outcome studies on spinal displacements verified by way of x-rays.

1)   Treatment method must be a known treatment as used in Chiropractic Clinical Practice.

2)   Treatment must be used to reduce/correct spinal displacements on x-ray.

3)   Follow-up Radiography was utilized to document reduction in spinal subluxation/displacement.

4)   Patient must have had a specified condition with one of the following outcome measurements in addition to radiography: 1) an acceptable positive orthopedic exam finding such as: range of motion, palpatory findings, pressure algometry, emg findings, etc...or 2) an acceptable patient outcome assessment such as: health status, quality of life score, NRS, VAS, Oswestry low back pain, etc...

C. Development of the PCCRP Guidelines and Review Process

1. Internal Drafting and Review

            The PCCRP Guideline committee consists of 25 panel members. The first 5 of these members are the principal investigators:

 

Deed E. Harrison DC:                           Chair of the PCCRP Guidelines

Donald D. Harrison DC, PhD, MSE:                Principal PCCRP Investigator

Christopher Kent, DC, JD:                               Principal PCCRP Investigator

Joseph Betz BS, DC:                                        Principal PCCRP Investigator

Paul A. Oakley MS, DC:                                  Principal PCCRP Investigator

 

            Panel members were chosen based on their Chiropractic clinical practice experience, their position as educational experts in the Chiropractic profession, and/or their research publication experience in the Chiropractic sciences.

            The 5 principal investigators met over the internet, performed preliminary literature searches as described above, and outlined the 13 respective sections of the PCCRP guidelines. The 5 principal investigators then asked the remaining 20 panel members to complete a given section or asked the panelist to choose a section that they had a primary knowledge and interest in. Each of the 13 Sections of the Guidelines was drafted by at least 2 panel members.

            Upon completion of the initial PCCRP Guideline draft, all 25 members were asked to review the document in its entirety and complete a review form (See Appendix 1). All panel review forms were then analyzed by Harrison DE and Harrison DD and the PCCRP Guideline draft was revised accordingly. Following this 1st revision, all the panel members were then asked to review the PCCRP document again and complete a second review form (Appendix 1).

            Thus, the PCCRP Guideline was subjected to two internal consensus reviews.

 2. External Review

      Following the 2 PCCRP Guideline panel draft reviews, the document was sent out for five phases of External Review. These five phases included:

a. Phase I: The PCCRP guideline was sent to a panel of 12 International Chiropractic experts. These 11 members were independent of the PCCRP panel and were from the United States (7 members), Canada (1), Ireland (1), Great Britain (1), Australia (1). The stipulation was that these individuals had to be involved in 1 of the following areas: Clinical research and private practice, Chiropractic Education at a CCE accredited Chiropractic College or University, hold a secondary JD (law) degree in addition to their DC degree, Editor in Chief of a peer-reviewed indexed Chiropractic research journal, and be in active clinical practice and actively involved in a major Chiropractic ‘political’ organization. These 11 individual Chiropractic experts were asked to review and evaluate the PCCRP guidelines with the AGREE Instrument.¹

b. Phase II: A second set of independent chiropractic experts were sent the PCCRP Guideline draft at the same time as those in Phase I. This second set of experts consisted of chiropractors who simultaneously held Medical degrees. The stipulation was that the individual had to have been in active Chiropractic clinical practice for at least 5 years prior to attaining their Medical degree and switching their focus to active Medical clinical practice. We identified 2 experts that fit these criteria. These 2 experts were asked to review and evaluate the PCCRP guidelines with the AGREE Instrument.¹

c. Phase III: At the same time as Phases I and II, the PCCRP guidelines were sent to the major Chiropractic political organizations for their review. These political organizations included: 1. The International Chiropractors Association (ICA), 2. The World Chiropractic Alliance (WCA), 3. The American Chiropractic Association, 4. The Canadian Chiropractic Association (CCA), 5. The Chiropractic Association of Australia (CAA), 7. The Chiropractic Association of Ireland (CAI), 8. The World Federation of Chiropractic (WFC), 9. The British Chiropractic Association (BCA), 10. The United Chiropractic Association (UCA), 11. The FSCO, 12. The New Zealand Chiropractic Association. These 12 Chiropractic political organizations were asked to review and evaluate the PCCRP Guidelines with either the AGREE Instrument¹ or the evaluation instrument in Appendix 1.

d. Phase IV: At the same time as Phases I-III, the PCCRP guidelines were sent to all Chiropractic Colleges, nationally and internationally. The colleges were asked to review the PCCRP guidelines and provide feedback with their choice of either the AGREE Instrument¹ or the evaluation instrument in Appendix 1.

e. Phase V: Following Phases I-IV, a website was set up (pccrp.org, pccrp.com) where the guidelines were posted and open for review from the Chiropractic profession at large. The evaluation instrument in Appendix 1 was posted on the website and willing participants from the profession completed this form.

Discussion

            In each of the five Phases of PCCRP Guideline review and evaluation, the ‘evaluators’ were given a minimum of 4 weeks to complete their reviews. Following the completion of Phases I-IV of the external review process, the 5 principle investigors of the PCCRP evaluated all the submitted reviews. The validity and applicability of the comments/criticisms was evaluated and a consensus of at least 3/5 (a majority) of principal investigators was needed prior to altering/revising the draft of the PCCRP Guideline document. This was the 3^rd draft of the document.

      The fourth and final revision of the PCCRP Guideline occurred following the comments from the Chiropractic Profession at large in Phase V. The validity and applicability of the comments/criticisms was evaluated by the 5 principal investigators and a consensus of at least 3/5 (a majority) of principal investigators was needed prior to altering/revising the draft of the PCCRP Guideline document.

      Thus, the PCCRP Guideline underwent 4 primary draft revisions. This final draft is/will be the completed version of the PCCRP Guideline.

 V. Possible Stake Holders’ Conflicts of Interest

A. Introduction

According to Linton & Peachy², “Guidelines must emanate from a credible and acceptable source. Governments do not qualify on either ground.” Additionally, “The second group of non-medical organizations that might attempt to impose standards includes third-party payers, insurance groups, and, perhaps hospital administrative organizations”.²  

In an article published in JAMA investigating potential conflict of interest of authors of Clinical Practice Guidelines (CPG’s), Chaudrey³ stated, “if individual authors have relationships that pose a potential conflict of interest, readers of these CPG’s may wish to know about them to evaluate the merit of those guidelines.”³ The author continues, “Financial conflicts of interest for authors of CPGs are of particular importance since they may not only influence the specific practice of these authors but also those of the physicians following the recommendations contained within the guidelines.”³

Eccles is quoted as stating, “There are good theoretical reasons to believe that individuals’ biases are better balanced in multidisciplinary groups, and that such balance will produce more valid guidelines.”⁴ A “Multidisciplinary” composition for a guideline of the nature of the current PCCRP Guidelines (for the chiropractic profession) does not imply the inclusion of medical and/or osteopathic physicians. Rather, we believe that a more representative group of chiropractic researchers and clinicians, whose primary focus was/is clinical treatment of patient conditions as chiropractic clincians either currently or in the past, is most appropriate.

In discussing the biases and conflicts in evidence based medicine (EBM) and CGP development, Arnett stated:

 “…the most important problem with EBM is that of its ethics. EBM is not a physician driven agenda. It has bypassed the clinicians (those physicians with clinical training, experience, and an extensive knowledge of health and disease) in favor of an alliance of managers and their statistical technocrats, who are empowered to define ‘best practices’," and “Their paychecks depend on churning out these definitions. These non-clinicians thus have acquired substantive influence over millions of clinical consultations without sharing any of the responsibility for the clinical consequences.”⁵

 Based upon this information, the 5 PCCRP principal investigators sought to develop radiology guidelines for the Chiropractic profession that were driven by chiropractic clinicians’ understanding of the individual patient needs on one hand and an extensive knowledge of the scientific literature relating to spinal health and pain disorders on the other. Input from 3^rd party payors, government agencies, managed care organizations and the like were not sought and not considered relevant. Involvement of chiropractic independent medical evaluators (IME’s) for insurance providers was minimized with only 2/25 individuals from the PCCRP having this designation. Involvement from chiropractic technique leaders and individuals who teach continuing education conferences for licensure renewal in the chiropractic profession were not considered to be conflicts of interest.

None of the 25 PCCRP panel members received funding of any kind for their involvement in the PCCRP Guidelines. However, because Chaudry stated, “Unfortunately, bias may occur both consciously and subconsciously, and therefore, its influence may go unrecognized”³; it is necessary to list and describe all possible conflicts of interest of all PCCRP panel members.

 

 B. The 5 PCCRP Principal Investigators:

Table 1.

Possible Conflicts of Interest for 5 Principal PCCRP Guideline Investigators

 

 Discussion

            The 5 principal PCCRP guideline investigators do not have any disabling conflicts of interest. The only possible ‘perceived’ conflict of interest would be the relationship of 2/5 to a specific named technique (Harrison DE and Harrison DD). However, how can the ties to a named technique influence the desire to utilize radiography in clinical chiropractic practice? The utilization of spinal radiography is influenced by physician training, experiences, personal views/biases, and personal knowledge. The two individuals tied to a named technique are two of the leading chiropractic researchers in the profession. They have extensive knowledge in the scientific literature and are reviewers for a combined 6 different peer-reviewed spine journals. Lastly, Harrison DD, holds advanced degrees in the field of mathematics and mechanical engineering, both of which fields have relevance to radiography assessment of spinal structure/position.

            One individual has previously chaired the development of a Chiropractic CPG known as the CCP Guidelines (Kent, C). However, this was/is an asset due to his extensive knowledge of the CGP guideline development process and the chiropractic literature in general. Furthermore, this individual is a leading chiropractic research investigator, is a reviewer for two peer-reviewed spine journals, and holds a secondary law (JD) degree. The fact that this individual holds a secondary law degree and is a licensed attorney was considered a great asset in developing the PCCRP guidelines.

            Four out of 5 principal investigators are affiliated with large chiropractic professional organizations. This was not considered to be a conflict of interest and is/was in fact an asset. These political organizations represent a large number of practicing chiropractors and thus their needs and their patients’ needs are likely to be considered in the PCCRP Guidelines. Furthermore, the affiliation with large chiropractic professional organizations adds validity to the PCCRP guidelines as it has the endorsement of these groups and does not simply come from chiropractic clinicians with ‘their own agendas’.

            Lastly, all 5 members of the PCCRP guidelines have been (Kent, C and Harrison DD) in private practice or are currently in active private practices, all 5 members are research investigators in the chiropractic sciences, and 3/5 hold dual advanced degrees in professional fields that are related to the PCCRP Guideline sections (Oakley P, in biomechanics).

 C.  The 20 Secondary PCCRP Panel Members:

 

Table 2.

Possible Conflicts of Interest for 20 Secondary PCCRP Guideline Panel Members.

 

Discussion

      The only different possible conflicts of interest that the secondary panel members have, compared to the principal investigators is that 3/21 are IME’s. Regarding the 2 individuals (Makos BK and Bacso SN) that hold full time positions as IME’s, these individuals were sought due to their previous involvement in a CGP (the Glen Erin guidelines) and due to their expertise in motion x-ray technology and assessment. However, the section (X-F) that these panel members drafted was independently drafted by 2 other panel members as well; 2/5 (Harrison DE and Betz J) of the principal investigators compiled the final draft of section X-F by combining these two drafts and adding further scientific sources prior to arriving at any recommendations. References

1. AGREE Collaboration. Appraisal of guidelines for Research & Evaluation. AGREE Instrument, 2001. http://www.agreecollaboration.org.
2. Linton AL, Peachey DK. Guidelines for medical practice: 1. The reasons why. Can Med Assoc J 1990; 143(6):485-490.
3. Choudhry NK, Stelfox HT, Detsky AS. Relationships between authors of clinical practice guidelines and the pharmaceutical industry. JAMA. 2002 Feb 6;287(5):612-7.
4. Eccles M, Mason J. How to develop cost conscious guidelines. Health Tech Assess 2001;5(16):1-83.

Jerome Arnett Jr., M.D. Individualized Health Care in Jeopardy Thursday, June 29, 2006. http://www.newsmax.com/archives/articles/2006/6/28/160841.shtml