Current Evidence for Diagnosis of Common Conditions Causing Low Back Pain: Systematic Review and Standardized Terminology Recommendations.

OBJECTIVE: The purpose of this systematic review is to evaluate and summarize current evidence for diagnosis of common conditions causing low back pain and to propose standardized terminology use. METHODS: A systematic review of the scientific literature was conducted from inception through December 2018. Electronic databases searched included PubMed, MEDLINE, CINAHL, Cochrane, and Index to Chiropractic Literature. Methodological quality was assessed with the Scottish Intercollegiate Guidelines Network checklists. RESULTS: Of the 3995 articles screened, 36 (8 systematic reviews and 28 individual studies) met final eligibility criteria. Diagnostic criteria for identifying likely discogenic, sacroiliac joint, and zygapophyseal (facet) joint pain are supported by clinical studies using injection-confirmed tissue provocation or anesthetic procedures. Diagnostic criteria for myofascial pain, sensitization (central and peripheral), and radicular pain are supported by expert consensus-level evidence. Criteria for radiculopathy and neurogenic claudication are supported by studies using combined expert-level consensus and imaging findings. CONCLUSION: The absence of high-quality, objective, gold-standard diagnostic methods limits the accuracy of current evidence-based criteria and results in few high-quality studies with a low risk of bias in patient selection and reference standard diagnosis. These limitations suggest practitioners should use evidence-based criteria to inform working diagnoses rather than definitive diagnoses for low back pain. To avoid the unnecessary complexity and confusion created by multiple overlapping and nonspecific terms, adopting International Association for the Study of Pain terminology and definitions is recommended.

Development of an Evidence-Based Practical Diagnostic Checklist and Corresponding Clinical Exam for Low Back Pain.

OBJECTIVE: The purpose of this study was to use scientific evidence to develop a practical diagnostic checklist and corresponding clinical exam for patients presenting with low back pain (LBP). METHODS: An iterative process was conducted to develop a diagnostic checklist and clinical exam for LBP using evidence-based diagnostic criteria. The checklist and exam were informed by a systematic review focused on summarizing current research evidence for office-based clinical evaluation of common conditions causing LBP. RESULTS: Diagnostic categories contained within the checklist and exam include nociceptive pain, neuropathic pain, and sensitization. Nociceptive pain subcategories include discogenic, myofascial, sacroiliac, and zygapophyseal (facet) joint pain. Neuropathic pain categories include neurogenic claudication, radicular pain, radiculopathy, and peripheral entrapment (piriformis and thoracolumbar syndrome). Sensitization contains 2 subtypes, central and peripheral sensitization. The diagnostic checklist contains individual diagnostic categories containing evidence-based criteria, applicable examination procedures, and checkboxes to record clinical findings. The checklist organizes and displays evidence for or against a working diagnosis. The checklist may help to ensure needed information is obtained from a patient interview and exam in a variety of primary spine care settings (eg, medical, chiropractic). CONCLUSION: The available evidence informs reasonable working diagnoses for many conditions causing or contributing to LBP. A practical diagnostic process including an exam and checklist is offered to guide clinical evaluation and demonstrate evidence for working diagnoses in clinical settings.

Integration of Doctors of Chiropractic Into Private Sector Health Care Facilities in the United States: A Descriptive Survey.

OBJECTIVE: The purpose of this study was to describe the demographic, facility, and practice characteristics of doctors of chiropractic (DCs) working in private sector health care settings in the United States. METHODS: We conducted an online, cross-sectional survey using a purposive sample of DCs (n = 50) working in integrated health care facilities. The 36-item survey collected demographic, facility, chiropractic, and interdisciplinary practice characteristics, which were analyzed with descriptive statistics. RESULTS: The response rate was 76% (n = 38). Most respondents were men and mid-career professionals with a mean 21 years of experience in chiropractic. Doctors of chiropractic reported working in hospitals (40%), multispecialty offices (21%), ambulatory clinics (16%), or other (21%) health care settings. Most (68%) were employees and received salary compensation (59%). The median number of DCs per setting was 2 (range 1-8). Most DCs used the same health record as medical staff and worked in the same clinical setting. More than 60% reported co-management of patients with medical professionals. Integrated DCs most often received and made referrals to primary care, physical medicine, pain medicine, orthopedics, and physical or occupational therapy. Although in many facilities the DCs were exclusive providers of spinal manipulation (43%), in most, manipulative therapies also were delivered by physical therapists and osteopathic or medical physicians. Informal face-to-face consultations and shared health records were the most common communication methods. CONCLUSIONS: Doctors of chiropractic are working in diverse medical settings within the private sector, in close proximity and collaboration with many provider types, suggesting a diverse role for chiropractors within conventional health care facilities.

Thoracolumbar fascia mobility and chronic low back pain: Phase 1 of a pilot and feasibility study assessing repeated measures and the influence of paraspinal muscle contraction.

BACKGROUND: Differential movement, or shear strain (SS), between layers of thoracolumbar fascia is reduced with chronic low back pain. To provide a foundation for clinical research involving SS, this study assessed temporal stability and the effect of paraspinal muscle contraction on SS in persons with chronic low back pain. METHODS: We used ultrasound imaging to measure SS in adults self-reporting low back pain ≥1 year. Images were obtained by placing a transducer 2-3 cm lateral to L2-3 with participants lying prone and relaxed on a table moving the lower extremities downward 15°, for 5 cycles at 0.5 Hz. To assess paraspinal muscle contraction effects, participants raised the head slightly from the table. SS was calculated using 2 computational methods. Method 1 averaged the maximum SS from each side during the third cycle. Method 2 used the maximum SS from any cycle (2-4) on each side, prior to averaging. SS was also assessed after a 4-week no manual therapy period. RESULTS: Of 30 participants (n = 14 female), mean age was 40 years; mean BMI 30.1. Mean (SE) SS in females with paraspinal muscle contraction was 66% (7.4) (method 1) and 78% (7.8) (method 2); 54% (6.9) (method 1) and 67% (7.3) (method 2) in males. With muscles relaxed, mean SS in females was 77% (7.6) (method 1) or 87% (6.8) (method 2); 63% (7.1) (method 1) and 78% (6.4) (method 2) in males. Mean SS decreased 8-13% in females and 7-13% in males after 4-weeks CONCLUSION: Mean SS in females was higher than males at each timepoint. Paraspinal muscle contraction temporarily reduced SS. Over a 4-week no-treatment period, mean SS (with paraspinal muscles relaxed) decreased. Methods less likely to induce muscle guarding and enabling assessment with broader populations are needed.

Thoracolumbar fascia mobility and chronic low back pain: Phase 2 of a pilot and feasibility study including multimodal chiropractic care.

BACKGROUND: Thoracolumbar fascia mobility observed with ultrasound imaging and calculated as shear strain is lower in persons with chronic low back pain. This pilot and feasibility trial assessed thoracolumbar shear strain in persons with chronic low back pain following spinal manipulation and over an 8-week course of multimodal chiropractic care. METHODS: Adults self-reporting chronic low back pain ≥ 1 year participated between September 2019 and April 2021 in a trial using ultrasound imaging to measure thoracolumbar shear strain. Ultrasound imaging occurred 2-3 cm lateral to L2-3 while participants relaxed prone on an automated table moving the lower extremities downward 15 degrees, for 5 cycles at 0.5 Hz. Pain intensity on an 11-point numerical rating scale, disability, pain interference, and global improvement were also collected. Participants received 8-weeks of twice-weekly chiropractic care including spinal manipulation, education, exercise, self-management advice and myofascial therapies. Shear strain was computed using 2 methods. The highest shear strain from movement cycles 2, 3, or 4 was averaged over right and left sides for each participant. Alternately, the highest shear strain from movement cycle 3 was used. All data were analyzed over time using mixed-effects models. Estimated mean changes are reported. RESULTS: Of 20 participants completing 8-weeks of chiropractic care (female n = 11), mean (SD) age was 41 years (12.6); mean BMI was 28.5 (6.2). All clinical outcomes improved at 8-weeks. Mean (95% confidence interval) pain intensity decreased 2.7 points (- 4.1 to - 1.4) for females and 2.1 points (- 3.7 to 0.4) for males. Mean Roland-Morris disability score decreased by 5 points (- 7.2 to - 2.8) for females, 2.3 points (- 4.9 to 0.2) for males. Mean PROMIS pain interference T-score decreased by 8.7 points (- 11.8 to - 5.5) for females, 5.6 points (- 9.5 to - 1.6) for males. Mean shear strain at 8-weeks increased in females 5.4% (- 9.9 to 20.8) or 15% (- 0.5 to 30.6), decreasing in males 6.0% (- 24.2 to 12.2) or 2% (- 21.0 to 16.8) depending on computational method. CONCLUSION: Spinal manipulation does not likely disrupt adhesions or relax paraspinal muscles enough to immediately affect shear strain. Clinical outcomes improved in both groups, however, shear strain only increased in females following 8-weeks of multimodal chiropractic care. Trial registration ClinicalTrials.gov registration is NCT03916705.

Care Outcomes for Chiropractic Outpatient Veterans (COCOV): a qualitative study with veteran stakeholders from a pilot trial of multimodal chiropractic care.

BACKGROUND: Low back pain (LBP) is common among military veterans seeking treatment in Department of Veterans Affairs (VA) healthcare facilities. As chiropractic services within VA expand, well-designed pragmatic trials and implementation studies are needed to assess clinical effectiveness and program uptake. This study evaluated veteran stakeholder perceptions of the feasibility and acceptability of care delivery and research processes in a pilot trial of multimodal chiropractic care for chronic LBP. METHODS: The qualitative study was completed within a mixed-method, single-arm, pragmatic, pilot clinical trial of chiropractic care for LBP conducted in VA chiropractic clinics. Study coordinators completed semi-structured, in person or telephone interviews with veterans near the end of the 10-week trial. Interviews were audiorecorded and transcribed verbatim. Qualitative content analysis using a directed approach explored salient themes related to trial implementation and delivery of chiropractic services. RESULTS: Of 40 participants, 24 completed interviews (60% response; 67% male gender; mean age 51.7 years). Overall, participants considered the trial protocol and procedures feasible and reported that the chiropractic care and recruitment methods were acceptable. Findings were organized into 4 domains, 10 themes, and 21 subthemes. Chiropractic service delivery domain encompassed 3 themes/8 subthemes: scheduling process (limited clinic hours, scheduling future appointments, attendance barriers); treatment frequency (treatment sufficient for LBP complaint, more/less frequent treatments); and chiropractic clinic considerations (hire more chiropractors, including female chiropractors; chiropractic clinic environment; patient-centered treatment visits). Outcome measures domain comprised 3 themes/4 subthemes: questionnaire burden (low burden vs. time-consuming or repetitive); relevance (items relevant for LBP study); and timing and individualization of measures (questionnaire timing relative to symptoms, personalized approach to outcomes measures). The online data collection domain included 2 themes/4 subthemes: user concerns (little difficulty vs. form challenges, required computer skills); and technology issues (computer/internet access, junk mail). Clinical trial planning domain included 2 themes/5 subthemes: participant recruitment (altruistic service by veterans, awareness of chiropractic availability, financial compensation); and communication methods (preferences, potential barriers). CONCLUSIONS: This qualitative study highlighted veteran stakeholders' perceptions of VA-based chiropractic services and offered important suggestions for conducting a full-scale, veteran-focused, randomized trial of multimodal chiropractic care for chronic LBP in this clinical setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT03254719.

Care Outcomes for Chiropractic Outpatient Veterans (COCOV): a single-arm, pragmatic, pilot trial of multimodal chiropractic care for U.S. veterans with chronic low back pain.

BACKGROUND: Over 25% of veterans seeking care at U.S. Veterans Health Administration facilities have chronic low back pain (LBP), with high rates of mental health comorbidities. The primary objective of this study was to assess the feasibility of participant recruitment, retention, and electronic data collection to prepare for the subsequent randomized trial of multimodal chiropractic care for pain management of veterans with chronic low back pain. The secondary objectives were to estimate effect sizes and variability of the primary outcome and choose secondary outcomes for the full-scale trial. METHODS: This single-arm pilot trial enrolled 40 veterans with chronic LBP at one Veterans Health Administration facility for a 10-week course of pragmatic multimodal chiropractic care. Recruitment was by (1) provider referral, (2) invitational letter from the electronic health record pre-screening, and (3) standard direct recruitment. We administered patient-reported outcome assessments through an email link to REDCap, an electronic data capture platform, at baseline and 5 additional timepoints. Retention was tracked through adherence to the treatment plan and completion rates of outcome assessments. Descriptive statistics were calculated for baseline characteristics and outcome variables. RESULTS: We screened 91 veterans over 6 months to enroll our goal of 40 participants. Seventy percent were recruited through provider referrals. Mean age (range) was 53 (22-79) years and 23% were female; 95% had mental health comorbidities. The mean number of chiropractic visits was 4.5 (1-7). Participants adhered to their treatment plan, with exception of 3 who attended only their first visit. All participants completed assessments at the in-person baseline visit and 80% at the week 10 final endpoint. We had no issues administering assessments via REDCap. We observed clinically important improvements on the Roland-Morris Disability Questionnaire [mean change (SD): 3.6 (6.1)] and on PROMIS® pain interference [mean change (SD): 3.6 (5.6)], which will be our primary and key secondary outcome, respectively, for the full-scale trial. CONCLUSIONS: We demonstrated the feasibility of participant recruitment, retention, and electronic data collection for conducting a pragmatic clinical trial of chiropractic care in a Veterans Health Administration facility. Using the pilot data and lessons learned, we modified and refined a protocol for a full-scale, multisite, pragmatic, National Institutes of Health-funded randomized trial of multimodal chiropractic care for veterans with chronic LBP that began recruitment in February 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT03254719.

Chiropractic Integration into Private Sector Medical Facilities: A Multisite Qualitative Case Study.

OBJECTIVES: Chiropractic care may have value in improving patient outcomes and decreasing opioid use, but little is known about the impetus for or process of incorporating these services into conventional medical settings. The purpose of this qualitative study was to describe organizational structures, care processes, and perceived value of chiropractic integration within U.S. private sector medical facilities. DESIGN: Multisite, comparative organizational case study. SETTINGS: Nine U.S. private sector medical facilities with on-site chiropractic care, including five hospitals and four clinics. PARTICIPANTS: One hundred and thirty-five key facility stakeholders including doctors of chiropractic (DCs), non-DC clinicians, support staff, administrators, and patients. METHODS: Researchers conducted 2-day site visits to all settings. Qualitative data were collected from audio-recorded, semi-structured, role-specified, individual interviews; standardized organizational data tables; and archival document review. A three-member, interdisciplinary team conducted thematic content analysis of verbatim transcripts using an existing conceptual framework and emergent codes. RESULTS: These nine medical facilities had unique organizational structures and reasons for initiating chiropractic care in their settings. Across sites, DCs were sought to take an evidence-based approach to patient care, work collaboratively within a multidisciplinary team, engage in interprofessional case management, and adopt organizational mission and values. Chiropractic clinics were implemented within existing human resources, physical plant, information technology, and administrative support systems, and often expanded over time to address patient demand. DCs usually were co-located with medical providers and integrated into the collaborative management of patients with musculoskeletal and co-morbid conditions. Delivery of chiropractic services was perceived to have high value among patients, medical providers, and administration. Patient clinical outcomes, patient satisfaction, provider productivity, and cost offset were identified as markers of clinic success. CONCLUSION: A diverse group of U.S. private sector medical facilities have implemented chiropractic clinics, and a wide variety of facility stakeholders report high satisfaction with the care provided.

Do informed consent documents for chiropractic clinical research studies meet readability level recommendations and contain required elements: a descriptive study.

BACKGROUND: Informed consent documents (ICD) in research are designed to educate research participants about the nature of the research project in which he or she may participate. United States (US) law requires the documents to contain specific elements present and be written in a way that is understandable to research participants. The purpose of this research is to determine if ICDs from randomized controlled trials conducted at chiropractic colleges meet recommended readability standards and contain the 13 content items required by US law. METHODS: This study was approved by Palmer College of Chiropractic's IRB #2012-12-3-T and was conducted between December 3, 2012 and February 14, 2013. We contacted the research directors of five chiropractic colleges that have received federal funding supporting their clinical research. A total of 13 informed consent documents from four chiropractic colleges were analyzed using the Flesch-Kincaid measurement. We assigned a grade-level readability score to the document based on the average of three separate grade level scores conducted on the three largest uninterrupted blocks of text. Content of the 13 ICDs was assessed using a 13-element checklist. A point was given for every element present in the document, giving a score range of "0, no elements are present", to "13, all elements are present." RESULTS: The mean Flesch-Kincaid grade level readability was 10.8 (range 7.2 -14.0). Our sample had a mean readability score 2.8 grade levels above the generally-accepted US average reading level. Content varied among the 13 informed consent forms, ranging from only nine elements present in one document to all 13 required in five documents. Additionally, we collated the risks presented in each document. CONCLUSION: These results strongly suggest that chiropractic clinical researchers are not developing ICDs at a readability level congruent with the national average acceptable level. The low number of elements in some of the informed consent documents raises concern that not all research participants were fully informed when given the informed consent, and it may suggest that some documents may not be in compliance with federal requirements. Risk varies among institutions and even within institutions for the same intervention.