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 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.

Veteran Response to Dosage in Chiropractic Therapy (VERDICT): Study Protocol of a Pragmatic Randomized Trial for Chronic Low Back Pain.

BACKGROUND: Low back pain is a leading cause of disability in veterans. Chiropractic care is a well-integrated, nonpharmacological therapy in Veterans Affairs health care facilities, where doctors of chiropractic provide therapeutic interventions focused on the management of low back pain and other musculoskeletal conditions. However, important knowledge gaps remain regarding the effectiveness of chiropractic care in terms of the number and frequency of treatment visits needed for optimal outcomes in veterans with low back pain. DESIGN: This pragmatic, parallel-group randomized trial at four Veterans Affairs sites will include 766 veterans with chronic low back pain who are randomly allocated to a course of low-dose (one to five visits) or higher-dose (eight to 12 visits) chiropractic care for 10 weeks (Phase 1). After Phase 1, participants within each treatment arm will again be randomly allocated to receive either monthly chiropractic chronic pain management for 10 months or no scheduled chiropractic visits (Phase 2). Assessments will be collected electronically. The Roland Morris Disability Questionnaire will be the primary outcome for Phase 1 at week 10 and Phase 2 at week 52. SUMMARY: This trial will provide evidence to guide the chiropractic dose in an initial course of care and an extended-care approach for veterans with chronic low back pain. Accurate information on the effectiveness of different dosing regimens of chiropractic care can greatly assist health care facilities, including Veterans Affairs, in modeling the number of doctors of chiropractic that will best meet the needs of patients with chronic low back pain.

Development of a Clinical Decision Aid for Chiropractic Management of Common Conditions Causing Low Back Pain in Veterans: Results of a Consensus Process.

OBJECTIVE: The purpose of this study was to develop a clinical decision aid for chiropractic management of common conditions causing low back pain (LBP) in veterans receiving treatment in US Veterans Affairs (VA) health care facilities. METHODS: A consensus study using an online, modified Delphi technique and Research Electronic Data Capture web application was conducted among VA doctors of chiropractic. Investigators reviewed the scientific literature pertaining to diagnosis and treatment of nonsurgical, neuromusculoskeletal LBP. Thirty seed statements summarizing evidence for chiropractic management, a graphical stepped management tool outlining diagnosis-informed treatment approaches, and support materials were then reviewed by an expert advisory committee. Email notifications invited 113 VA chiropractic clinicians to participate as Delphi panelists. Panelists rated the appropriateness of the seed statements and the stepped process on a 1-to-9 scale using the RAND/University of California, Los Angeles methodology. Statements were accepted when both the median rating and 80% of all ratings occurred within the highly appropriate range. RESULTS: Thirty-nine panelists (74% male) with a mean (standard deviation) age of 46 (11) years and clinical experience of 17 (11) years participated in the study. Accepted statements addressed included (1) essential components of chiropractic care, (2) treatments for conditions causing or contributing to LBP, (3) spinal manipulation mechanisms, (4) descriptions and mechanisms of commonly used chiropractic interventions, and (5) a graphical stepped clinical management tool. CONCLUSION: This study group produced a chiropractic clinical decision aid for LBP management, which can be used to support evidence-based care decisions for veterans with LBP.

Assessment of chiropractic care on strength, balance, and endurance in active-duty U.S. military personnel with low back pain: a protocol for a randomized controlled trial.

BACKGROUND: Low back pain (LBP) is a common cause of disability among U.S. military personnel. Approximately 20% of all diagnoses resulting in disability discharges are linked to back-related conditions. Because LBP can negatively influence trunk muscle strength, balance, and endurance, the military readiness of active-duty military personnel with LBP is potentially compromised. Chiropractic care may facilitate the strengthening of trunk muscles, the alteration of sensory and motor signaling, and a reduction in pain sensitivity, which may contribute to improving strength, balance, and endurance for individuals with LBP. This trial will assess the effects of chiropractic care on strength, balance, and endurance for active-duty military personnel with LBP. METHODS/DESIGN: This randomized controlled trial will allocate 110 active-duty military service members aged 18-40 with non-surgical acute, subacute, or chronic LBP with pain severity of ≥2/10 within the past 24 h. All study procedures are conducted at a single military treatment facility within the continental United States. Participants are recruited through recruitment materials approved by the institutional review board, such as posters and flyers, as well as through provider referrals. Group assignment occurs through computer-generated random allocation to either the study intervention (chiropractic care) or the control group (waiting list) for a 4-week period. Chiropractic care consists primarily of spinal manipulation at a frequency and duration determined by a chiropractic practitioner. Strength, balance, and endurance outcomes are obtained at baseline and after 4 weeks. The primary outcome is a change between baseline and 4 weeks of peak isometric strength, which is measured by pulling on a bimanual handle in a semi-squat position. Secondary outcomes include balance time during a single-leg standing test and trunk muscle endurance with the Biering-Sorensen test. Patient-reported outcomes include pain severity, disability measured with the Roland Morris Disability Questionnaire, symptom bothersomeness, PROMIS-29, Fear Avoidance Beliefs Questionnaire, expectations of care, physical activity, and global improvement. DISCUSSION: This trial may help inform further research on biological mechanisms related to manual therapies employed by chiropractic practitioners. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02670148 Registered on 1 February 2016.

Patients receiving chiropractic care in a neurorehabilitation hospital: a descriptive study.

OBJECTIVES: Individuals rehabilitating from complex neurological injury require a multidisciplinary approach, which typically does not include chiropractic care. This study describes inpatients receiving multidisciplinary rehabilitation including chiropractic care for brain injury, spinal cord injury (SCI), stroke, and other complex neurological conditions. DESIGN: Chiropractic services were integrated into Crotched Mountain Specialty Hospital (CMSH) through this project. Patient characteristics and chiropractic care data were collected to describe those receiving care and the interventions during the first 15 months when chiropractic services were available. SETTING: CMSH, a 62-bed subacute multidisciplinary rehabilitation, skilled nursing facility located in Greenfield, New Hampshire, USA. RESULTS: Patient mean (SD) age (n=27) was 42.8 (13) years, ranging from 20 to 64 years. Males (n=18, 67%) and those of white race/ethnicity (n=23, 85%) comprised the majority. Brain injury (n=20) was the most common admitting condition caused by trauma (n=9), hemorrhage (n=7), infarction (n=2), and general anoxia (n=2). Three patients were admitted for cervical SCI, 1 for ankylosing spondylitis, 1 for traumatic polyarthropathy, and 2 for respiratory failure with encephalopathy. Other common comorbid diagnoses potentially complicating the treatment and recovery process included myospasm (n=13), depression (n=11), anxiety (n=10), dysphagia (n=8), substance abuse (n=8), and candidiasis (n=7). Chiropractic procedures employed, by visit (n=641), included manual myofascial therapies (93%), mechanical percussion (83%), manual muscle stretching (75%), and thrust manipulation (65%) to address patients with spinal-related pain (n=15, 54%), joint or regional stiffness (n= 14, 50%), and extremity pain (n=13, 46%). Care often required adapting to participant limitations or conditions. Such adaptations not commonly encountered in outpatient settings where chiropractic care is usually delivered included the need for lift assistance, wheelchair dependence, contractures, impaired speech, quadriplegia/paraplegia, and the presence of feeding tubes and urinary catheters. CONCLUSION: Patients suffered significant functional limitations and comorbidity resulting in modifications to the typical delivery of chiropractic care. Chiropractic services focused on relieving musculoskeletal pain and stiffness.

Essential literature for the chiropractic profession: Results and implementation challenges from a survey of international chiropractic faculty.

OBJECTIVE: Scientific literature applicable to chiropractic practice proliferates in quantity, quality, and source. Chiropractic is a worldwide profession and varies in scope between states or provinces and from country to country. It is logical to consider that the focus and emphasis of chiropractic education varies between programs as well. This original research study endeavored to determine "essential literature" recommended by chiropractic faculty. The purpose of this article is (1) to share our results and (2) to promote discussion and explore means for future collaboration of chiropractic faculty through a worldwide platform. METHODS: A 2-phase recruitment occurred initially at the institutional level and subsequently at the faculty level. A Web-based survey used qualitative data collection methods to gather bibliographic citations. Descriptive statistics were calculated for demographics, and citation responses were ranked per number of recommendations, grouped into categories, and tabulated per journal source and publication date. RESULTS: Forty-one chiropractic programs were contacted, resulting in 30 participating chiropractic programs (16 US and 14 international). Forty-five faculty members completed the entire survey, submitting 126 peer-reviewed publications and 25 additional citations. Readings emphasized clinical management of spine pain, the science of spinal manipulation, effectiveness of manual therapies, teaching of chiropractic techniques, outcomes assessments, and professional issues. CONCLUSION: A systematic approach to surveying educators in international chiropractic institutions was accomplished. The results of the survey provide a list of essential literature for the chiropractic profession. We recommend establishing a chiropractic faculty registry for improved communication and collaboration.

The effect of chiropractic treatment on the reaction and response times of special operation forces military personnel: study protocol for a randomized controlled trial.

BACKGROUND: Chiropractic care is commonly used to treat musculoskeletal conditions and has been endorsed by clinical practice guidelines as being evidence-based and cost-effective for the treatment of patients with low back pain. Gaps in the literature exist regarding the physiological outcomes of chiropractic treatment. Previous pilot work has indicated the possibility of improvements in response time following the application of chiropractic treatment. However, it is unknown whether or not chiropractic treatment is able to improve reaction and response times in specific populations of interest. One such population is the U.S. military special operation forces' (SOF) personnel. METHODS: This study is a randomized controlled trial of 120 asymptomatic volunteer SOF personnel. All participants are examined by a study doctor of chiropractic (DC) for eligibility prior to randomization. The participants are randomly allocated to either a treatment group receiving four treatments of chiropractic manipulative therapy (CMT) over 2 weeks or to a wait-list control group. The wait-list group does not receive any treatment but has assessments at the same time interval as the treatment group. The outcome measures are simple reaction times for dominant hand and dominant foot, choice reaction time with prompts calling for either hand or either foot, response time using Fitts' law tasks for small movements involving eye-hand coordination, and brief whole body movements using the t-wall, a commercially available product. At the first visit, all five tests are completed so that participants can familiarize themselves with the equipment and protocol. Assessments at the second and the final visits are used for data analysis. DISCUSSION: SOF personnel are highly motivated and extremely physically fit individuals whose occupation requires reaction times that are as quick as possible during the course of their assigned duties. A goal of CMT is to maximize the functionality and integration of the neuromusculoskeletal systems. Therefore, chiropractic treatment may be able to optimize the capacity of the numerous components of those systems, resulting in improved reaction time. The objective of this study is to test the hypothesis that CMT improves reaction and response times in asymptomatic SOF personnel. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02168153 . Registered on 12 June 2014.

Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial.

BACKGROUND: Low back pain is highly prevalent and one of the most common causes of disability in U.S. armed forces personnel. Currently, no single therapeutic method has been established as a gold standard treatment for this increasingly prevalent condition. One commonly used treatment, which has demonstrated consistent positive outcomes in terms of pain and function within a civilian population is spinal manipulative therapy provided by doctors of chiropractic. Chiropractic care, delivered within a multidisciplinary framework in military healthcare settings, has the potential to help improve clinical outcomes for military personnel with low back pain. However, its effectiveness in a military setting has not been well established. The primary objective of this study is to evaluate changes in pain and disability in active duty service members with low back pain who are allocated to receive usual medical care plus chiropractic care versus treatment with usual medical care alone. METHODS/DESIGN: This pragmatic comparative effectiveness trial will enroll 750 active duty service members with low back pain at three military treatment facilities within the United States (250 from each site) who will be allocated to receive usual medical care plus chiropractic care or usual medical care alone for 6 weeks. Primary outcomes will include the numerical rating scale for pain intensity and the Roland-Morris Disability Questionnaire at week 6. Patient reported outcomes of pain, disability, bothersomeness, and back pain function will be collected at 2, 4, 6, and 12 weeks from allocation. DISCUSSION: Because low back pain is one of the leading causes of disability among U.S. military personnel, it is important to find pragmatic and conservative treatments that will treat low back pain and preserve low back function so that military readiness is maintained. Thus, it is important to evaluate the effects of the addition of chiropractic care to usual medical care on low back pain and disability. TRIAL REGISTRATION: The trial discussed in this article was registered in ClinicalTrials.gov with the NCT01692275 Date of registration: 6 September 2012.

Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.

BACKGROUND: Manual cervical distraction (MCD) is a traction-based therapy performed with a manual contact over the cervical region producing repeating cycles while patients lie prone. This study evaluated a traction force-based minimal intervention for use as an attention-touch control in clinical trials of MCD for patients with chronic neck pain. METHODS: We conducted a mixed-methods, pilot randomized clinical trial in adults with chronic neck pain. Participants were allocated to three traction force ranges of MCD: low force/minimal intervention (0-20 N), medium force (21-50 N), or high force (51-100 N). Clinicians delivered five treatments over two weeks consisting of three sets of five cycles of MCD at the C5 vertebra and occiput. Traction forces were measured at each treatment. Patient-reported outcomes included a pain visual analogue scale (VAS), Neck Disability Index (NDI), Credibility and Expectancy Questionnaire (CEQ), and adverse effects. A qualitative interview evaluated treatment group allocation perceptions. RESULTS: We randomized 48 participants, allocating an average of five each month. Forty-five participants completed the trial with three participants lost to follow-up. Most participants were women (65%) and white (92%) with a mean (SD) age of 46.8 (12.5) years. Mean traction force values were within the prescribed force ranges for each group at the C5 and occiput levels. Neck pain VAS demonstrated a benefit for high traction force MCD compared to the low force group [adjusted mean difference 15.6; 95% confidence interval (CI) 1.6 to 29.7]. Participants in the medium traction force group demonstrated improvements in NDI compared to the low force group (adjusted mean difference 3.0; 95% CI 0.1 to 5.9), as did participants in the high traction force group (adjusted mean difference 2.7; 95% CI -0.1 to 5.6). CEQ favored the high force group. Most low force participants correctly identified their treatment allocation in the qualitative interview. No serious adverse events were documented. CONCLUSIONS: This pilot study demonstrated the feasibility of a clinical trial protocol and the utility of a traction-based, minimal intervention as an attention-touch control for future efficacy trials of MCD for patients with neck pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT01765751 (Registration Date 30 May 2012).

Clinician proficiency in delivering manual treatment for neck pain within specified force ranges.

BACKGROUND CONTEXT: Neck pain is a common musculoskeletal complaint responsive to manual therapies. Doctors of chiropractic commonly use manual cervical distraction, a mobilization procedure, to treat neck pain patients. However, it is unknown if clinicians can consistently apply standardized cervical traction forces, a critical step toward identifying an optimal therapeutic dose. PURPOSE: To assess clinicians' proficiency in delivering manually applied traction forces within specified ranges to neck pain patients. STUDY DESIGN: An observational study nested within a randomized clinical trial. SAMPLE: Two research clinicians provided study interventions to 48 participants with neck pain. OUTCOME MEASURES: Clinician proficiency in delivering cervical traction forces within three specified ranges (low force, less than 20 N; medium force, 21-50 N; and high force 51-100 N). METHODS: Participants were randomly allocated to three force-based treatment groups. Participants received five manual cervical distraction treatments over 2 weeks while lying prone on a treatment table instrumented with force sensors. Two clinicians delivered manual traction forces according to treatment groups. Clinicians treated participants first without real-time visual feedback displaying traction force and then with visual feedback. Peak traction force data were extracted and descriptively analyzed. RESULTS: Clinicians delivered manual cervical distraction treatments within the prescribed traction force ranges 75% of the time without visual feedback and 97% of the time with visual feedback. CONCLUSIONS: This study demonstrates that doctors of chiropractic can successfully deliver prescribed traction forces while treating neck pain patients, enabling the capability to conduct force-based dose response clinical studies.