How well do participants in clinical trials represent the U.S. population with chronic neck or back pain?

BACKGROUND: Randomized clinical trials (RCTs) are the gold standard for assessing treatment effectiveness; however, they have been criticized for generalizability issues such as how well trial participants represent those who receive the treatments in clinical practice. We assessed the representativeness of participants from eight RCTs for chronic spine pain in the U.S., which were used for an individual participant data meta-analysis on the cost-effectiveness of spinal manipulation for spine pain. In these clinical trials, spinal manipulation was performed by chiropractors. METHODS: We conducted a retrospective secondary analysis of RCT data to compare trial participants' socio-demographic characteristics, clinical features, and health outcomes to a representative sample of (a) U.S. adults with chronic spine pain and (b) U.S. adults with chronic spine pain receiving chiropractic care, using secondary data from the National Health Interview Survey (NHIS) and Medical Expenditure Panel Survey (MEPS). We assessed differences between trial and U.S. spine populations using independent t-tests for means and z-tests for proportions, accounting for the complex multi-stage survey design of the NHIS and MEPS. RESULTS: We found the clinical trials had an under-representation of individuals from health disparity populations with lower percentages of racial and ethnic minority groups (Black/African American 7% lower, Hispanic 8% lower), less educated (No high school degree 19% lower, high school degree 11% lower), and unemployed adults (25% lower) with worse health outcomes (physical health scores 2.5 lower and mental health scores 5.3 lower using the SF-12/36) relative to the U.S. population with spine pain. While the odds of chiropractic use in the U.S. are lower for individuals from health disparity populations, the trials also under-represented these populations relative to U.S. adults with chronic spine pain who visit a chiropractor. CONCLUSIONS: Health disparity populations are not well represented in spine pain clinical trials. Embracing key community-based approaches, which have shown promise for increasing participation of underserved communities, is needed.

Effectiveness of spinal manipulation and biopsychosocial self-management compared to medical care for low back pain: a randomized trial study protocol.

BACKGROUND: Chronic low back pain (cLBP) is widespread, costly, and burdensome to patients and health systems. Little is known about non-pharmacological treatments for the secondary prevention of cLBP. There is some evidence that treatments addressing psychosocial factors in higher risk patients are more effective than usual care. However, most clinical trials on acute and subacute LBP have evaluated interventions irrespective of prognosis. METHODS: We have designed a phase 3 randomized trial with a 2 × 2 factorial design. The study is also a Hybrid type 1 trial with focus on intervention effectiveness while simultaneously considering plausible implementation strategies. Adults (n = 1000) with acute/subacute LBP at moderate to high risk of chronicity based on the STarT Back screening tool will be randomized in to 1 of 4 interventions lasting up to 8 weeks: supported self-management (SSM), spinal manipulation therapy (SMT), both SSM and SMT, or medical care. The primary objective is to assess intervention effectiveness; the secondary objective is to assess barriers and facilitators impacting future implementation. Primary effectiveness outcome measures are: (1) average pain intensity over 12 months post-randomization (pain, numerical rating scale); (2) average low back disability over 12 months post-randomization (Roland-Morris Disability Questionnaire); (3) prevention of cLBP that is impactful at 10-12 months follow-up (LBP impact from the PROMIS-29 Profile v2.0). Secondary outcomes include: recovery, PROMIS-29 Profile v2.0 measures to assess pain interference, physical function, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities. Other patient-reported measures include LBP frequency, medication use, healthcare utilization, productivity loss, STarT Back screening tool status, patient satisfaction, prevention of chronicity, adverse events, and dissemination measures. Objective measures include the Quebec Task Force Classification, Timed Up & Go Test, the Sit to Stand Test, and the Sock Test assessed by clinicians blinded to the patients' intervention assignment. DISCUSSION: By targeting those subjects at higher risk this trial aims to fill an important gap in the scientific literature regarding the effectiveness of promising non-pharmacological treatments compared to medical care for the management of patients with an acute episode of LBP and the prevention of progression to a severe chronic back problem. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03581123.

Survey analysis to determine the impact of evidence informed practice education upon East Asian medicine faculty clinical instruction and students' skills, knowledge, attitudes and behaviors within a master's degree program.

BACKGROUND: Between 2013 and 2018 Pacific College of Health and Science (formerly Pacific College of Oriental Medicine) trained faculty and developed curriculum in evidence informed practice (EIP), with support from a grant from the National Institutes of Health (NIH). A three-credit (45 h) Foundations of EIP course, and online EIP learning modules (developed as part of a previous NIH R25 award), were used for faculty and student training. In addition, EIP was incorporated into 73% of the East Asian medicine degree program. Clinical integration of EIP in the College clinic was enhanced by improving access to reference sources, including additional EIP-related questions to the patient intake forms, requiring the use of a patient-centered outcome instrument, and assessing students' clinical EIP competencies. METHODS: Master's degree students' self-reported EIP skills, knowledge, attitudes and behaviors were assessed before and after taking the Foundations of EIP course using a 17-question paper-based survey with an additional open-ended comments section. The survey was administered in 29 courses across all three Pacific College campuses. Clinical faculty self-reported EIP instruction, focusing on the EIP content and instructional approaches that were utilized, was evaluated on the New York City campus using a paper-based survey before and after changes were made to enhance the clinical integration of EIP. RESULTS: A total of 1181 completed EIP-course surveys consisting of 657 pre-EIP course surveys and 524 post-EIP course surveys were analyzed. There was a statistically significant improvement in students' EIP skills, knowledge and behaviors after completing the EIP course. Students' perception of the importance of EIP was high before and after the EIP course. Little change in Faculty's EIP-related clinical instruction was evident following the EIP-related changes that were made to the Clinic. CONCLUSION: Our study suggests that the three-credit (45 h) EIP course was effective at improving the EIP skills, knowledge and behaviors of this group of East Asian medicine students who were undertaking a master's degree that qualified them for licensure in acupuncture in the US. These students also demonstrated a high level of recognition for the importance of research and EIP both before and after the course. Training faculty clinical supervisors and providing greater access to evidence sources in the College clinic did not appear to increase EIP instructional activity.

Spinal rehabilitative exercise or manual treatment for the prevention of tension-type headache in adults.

This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the short- and long-term effects of manual treatment and spinal rehabilitative exercise for the prevention of tension-type headache in adults.

Spinal rehabilitative exercise or manual treatment for the prevention of cervicogenic headache in adults.

This is the protocol for a review and there is no abstract. The objectives are as follows: To quantify and compare the short- and long-term effects of manual treatment and spinal rehabilitative exercise for cervicogenic headache, classified according to the International Headache Society's (IHS) diagnostic criteria, with an active or placebo/sham comparison or wait-list control.

The Association Between Use of Chiropractic Care and Costs of Care Among Older Medicare Patients With Chronic Low Back Pain and Multiple Comorbidities.

OBJECTIVE: The purpose of this study was to determine whether use of chiropractic manipulative treatment (CMT) was associated with lower healthcare costs among multiply-comorbid Medicare beneficiaries with an episode of chronic low back pain (cLBP). METHODS: We conducted an observational, retrospective study of 2006 to 2012 Medicare fee-for-service reimbursements for 72326 multiply-comorbid patients aged 66 and older with cLBP episodes and 1 of 4 treatment exposures: chiropractic manipulative treatment (CMT) alone, CMT followed or preceded by conventional medical care, or conventional medical care alone. We used propensity score weighting to address selection bias. RESULTS: After propensity score weighting, total and per-episode day Part A, Part B, and Part D Medicare reimbursements during the cLBP treatment episode were lowest for patients who used CMT alone; these patients had higher rates of healthcare use for low back pain but lower rates of back surgery in the year following the treatment episode. Expenditures were greatest for patients receiving medical care alone; order was irrelevant when both CMT and medical treatment were provided. Patients who used only CMT had the lowest annual growth rates in almost all Medicare expenditure categories. While patients who used only CMT had the lowest Part A and Part B expenditures per episode day, we found no indication of lower psychiatric or pain medication expenditures associated with CMT. CONCLUSIONS: This study found that older multiply-comorbid patients who used only CMT during their cLBP episodes had lower overall costs of care, shorter episodes, and lower cost of care per episode day than patients in the other treatment groups. Further, costs of care for the episode and per episode day were lower for patients who used a combination of CMT and conventional medical care than for patients who did not use any CMT. These findings support initial CMT use in the treatment of, and possibly broader chiropractic management of, older multiply-comorbid cLBP patients.

Comparing Propensity Score Methods for Creating Comparable Cohorts of Chiropractic Users and Nonusers in Older, Multiply Comorbid Medicare Patients With Chronic Low Back Pain.

OBJECTIVE: Patients who use complementary and integrative health services like chiropractic manipulative treatment (CMT) often have different characteristics than do patients who do not, and these differences can confound attempts to compare outcomes across treatment groups, particularly in observational studies when selection bias may occur. The purposes of this study were to provide an overview on how propensity scoring methods can be used to address selection bias by balancing treatment groups on key variables and to use Medicare data to compare different methods for doing so. METHODS: We described 2 propensity score methods (matching and weighting). Then we used Medicare data from 2006 to 2012 on older, multiply comorbid patients who had a chronic low back pain episode to demonstrate the impact of applying methods on the balance of demographics of patients between 2 treatment groups (those who received only CMT and those who received no CMT during their episodes). RESULTS: Before application of propensity score methods, patients who used only CMT had different characteristics from those who did not. Propensity score matching diminished observed differences across the treatment groups at the expense of reduced sample size. However, propensity score weighting achieved balance in patient characteristics between the groups and allowed us to keep the entire sample. CONCLUSIONS: Although propensity score matching and weighting have similar effects in terms of balancing covariates, weighting has the advantage of maintaining sample size, preserving external validity, and generalizing more naturally to comparisons of 3 or more treatment groups. Researchers should carefully consider which propensity score method to use, as using different methods can generate different results.

Exploring patient satisfaction: a secondary analysis of a randomized clinical trial of spinal manipulation, home exercise, and medication for acute and subacute neck pain.

OBJECTIVE: The purpose of this study was to assess satisfaction with specific aspects of care for acute neck pain and explore the relationship between satisfaction with care, neck pain, and global satisfaction. METHODS: This study was a secondary analysis of patient satisfaction from a randomized trial of spinal manipulation therapy (SMT) delivered by doctors of chiropractic, home exercise and advice (HEA) delivered by exercise therapists, and medication (MED) prescribed by a medical doctors for acute/subacute neck pain. Differences in satisfaction with specific aspects of care were analyzed using a linear mixed model. The relationship between specific aspects of care and (1) change in neck pain (primary outcome of the randomized trial) and (2) global satisfaction were assessed using Pearson's correlation and multiple linear regression. RESULTS: Individuals receiving SMT or HEA were more satisfied with the information and general care received than MED group participants. Spinal manipulation therapy and HEA groups reported similar satisfaction with information provided during treatment; however, the SMT group was more satisfied with general care. Satisfaction with general care (r = -0.75 to -0.77; R(2) = 0.55-0.56) had a stronger relationship with global satisfaction compared with satisfaction with information provided (r = -0.65 to 0.67; R(2) = 0.39-0.46). The relationship between satisfaction with care and neck pain was weak (r = 0.17-0.38; R(2) = 0.08-0.21). CONCLUSIONS: Individuals with acute/subacute neck pain were more satisfied with specific aspects of care received during spinal manipulation therapy or home exercise interventions compared to receiving medication. The relationship between neck pain and satisfaction with care was weak.

Causally interpretable meta-analysis: Clearly defined causal effects and two case studies.

Meta-analysis is commonly used to combine results from multiple clinical trials, but traditional meta-analysis methods do not refer explicitly to a population of individuals to whom the results apply and it is not clear how to use their results to assess a treatment's effect for a population of interest. We describe recently-introduced causally interpretable meta-analysis methods and apply their treatment effect estimators to two individual-participant data sets. These estimators transport estimated treatment effects from studies in the meta-analysis to a specified target population using the individuals' potentially effect-modifying covariates. We consider different regression and weighting methods within this approach and compare the results to traditional aggregated-data meta-analysis methods. In our applications, certain versions of the causally interpretable methods performed somewhat better than the traditional methods, but the latter generally did well. The causally interpretable methods offer the most promise when covariates modify treatment effects and our results suggest that traditional methods work well when there is little effect heterogeneity. The causally interpretable approach gives meta-analysis an appealing theoretical framework by relating an estimator directly to a specific population and lays a solid foundation for future developments.

Cross-Sectional Survey of Acupuncturists in the United States Who Prescribed Chinese Herbal Medicine for Patients with Symptoms Likely Related to COVID-19.

Objective: The objective of this study was to examine the prescribing of Chinese herbal medicine (CHM) by licensed acupuncturists in the United States during the COVID-19 pandemic. Methods: A 28-question survey with nine branching questions was disseminated through collegial networks, paid advertisements, and a study website in April-July 2021. Participants indicated that they were licensed acupuncturists who treated more than five patients for symptoms likely related to COVID-19 to gain entry to the full survey. Surveys were undertaken electronically through the Research Electronic Data Capture (REDCap) system. Results: The survey was undertaken by 103 participants representing all US geographic regions and had an average of 17 years in practice. Sixty-five percent received or intended to receive the COVID-19 vaccine. Phone and videoconference were the predominant methods of patient contact; granules and pill forms of CHM were the most prescribed. A wide variety of information sources were used in devising patient treatments inclusive of anecdotal, observational, and scientific sources. Most patients were not receiving biomedical treatment. Ninety-seven percent of participants reported that they had no patients die of COVID-19, and the majority reported that <25% of their patients developed long hauler syndrome (post-acute sequelae SARS-CoV-2 infection). Conclusions: This study demonstrates that licensed acupuncturists were treating COVID-19 infected individuals in the United States during the early stages of the pandemic, and for many such patients this was the only therapeutic intervention they had access to from a licensed health care provider. Information disseminated from China through collegial networks, along with published sources including scientific studies, informed the approach to treatment. This study provides insight into an unusual circumstance in which clinicians needed to establish evidence-based approaches to the treatment of a new disease during a public health emergency.

Effectiveness of Spinal Manipulation and Biopsychosocial Self-Management compared to Medical Care for Low Back Pain: A Randomized Trial Study Protocol.

Background Chronic low back pain (cLBP) is widespread, costly, and burdensome to patients and health systems. Little is known about non-pharmacological treatments for the secondary prevention of cLBP. There is some evidence that treatments addressing psychosocial factors in higher risk patients are more effective than usual care. However, most clinical trials on acute and subacute LBP have evaluated interventions irrespective of prognosis. Methods We have designed a phase 3 randomized trial with a 2x2 factorial design. The study is also a Hybrid type 1 trial with focus on intervention effectiveness while simultaneously considering plausible implementation strategies. Adults (n = 1000) with acute/subacute LBP at moderate to high risk of chronicity based on the STarT Back screening tool will be randomized in to 1 of 4 interventions lasting up to 8 weeks: supported self-management (SSM), spinal manipulation therapy (SMT), both SSM and SMT, or medical care. The primary objective is to assess intervention effectiveness; the secondary objective is to assess barriers and facilitators impacting future implementation. Primary effectiveness outcome measures are: (1) average pain intensity over 12 months post-randomization (pain, numerical rating scale); (2) average low back disability over 12 months post-randomization (Roland-Morris Disability Questionnaire); (3) prevention of cLBP that is impactful at 10-12 months follow-up (LBP impact from the PROMIS-29 Profile v2.0). Secondary outcomes include: recovery, PROMIS-29 Profile v2.0 measures to assess pain interference, physical function, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities. Other patient-reported measures include LBP frequency, medication use, healthcare utilization, productivity loss, STarT Back screening tool status, patient satisfaction, prevention of chronicity, adverse events, and dissemination measures. Objective measures include the Quebec Task Force Classification, Timed Up & Go Test, the Sit to Stand Test, and the Sock Test assessed by clinicians blinded to the patients' intervention assignment. Discussion By targeting those subjects at higher risk this trial aims to fill an important gap in the scientific literature regarding the effectiveness of promising non-pharmacological treatments compared to medical care for the management of patients with an acute episode of LBP and the prevention of progression to a severe chronic back problem. Trial registration: ClinicalTrials.gov Identifier: NCT03581123.

A Randomized Trial of 21 Days of Loving Kindness Meditation for Stress Reduction and Emotional Well-being Within an Online Health Community for Patients, Family, and Friends Experiencing a Cancer Health Journey.

Objectives: CaringBridge (CB) is an online health community for people undergoing challenging health journeys. Loving Kindness Meditation (LKM) is a systemized mind-body approach developed to increase loving acceptance and has previously been reported to increase resilience in the face of adversity. Materials and Methods: Results of a randomized controlled trial of immediate compared with deferred 21-day LKM intervention in an online community are reported. The deferred group received LKM intervention after a waiting period of 3 weeks. Inclusion criteria were >18 years old, ability to understand English, willingness to participate in a mind-body practice, and use of CB for a cancer journey. Change in perceived stress, self-compassion, social connectedness and assurance, and compassionate love scales from baseline to 21 days was assessed. Results: Of the 979 participants included in the study, 649 (66%) provided 3-week follow-up data and 330 (49%) self-reported engaging in the LKM practice 5 or more days/week. Participants in the immediate LKM group reported medium effect size improvement in stress (0.4), self-compassion (0.5), and social connectedness (0.4) compared with the deferred LKM group. Changes in perceived stress and self-compassion were larger in magnitude and increased with more frequent engagement in LKM. Conclusions: The immediate LKM group showed improvements in stress, self-compassion, and social connectedness compared with the deferred control group. Differential study retention rates by treatment arm and self-reported engagement in LKM subject the results to selection bias. Future research of similar interventions within online health communities might pay greater attention to promoting intervention adherence and engaging a more diverse economic and racial/ethnic population. ClinicalTrials.gov (NCT05002842).

Multidisciplinary integrative care versus chiropractic care for low back pain: a randomized clinical trial.

BACKGROUND: Low back pain (LBP) is influenced by interrelated biological, psychological, and social factors, however current back pain management is largely dominated by one-size fits all unimodal treatments. Team based models with multiple provider types from complementary professional disciplines is one way of integrating therapies to address patients' needs more comprehensively. METHODS: This parallel group randomized clinical trial conducted from May 2007 to August 2010 aimed to evaluate the relative clinical effectiveness of 12 weeks of monodisciplinary chiropractic care (CC), versus multidisciplinary integrative care (IC), for adults with sub-acute and chronic LBP. The primary outcome was pain intensity and secondary outcomes were disability, improvement, medication use, quality of life, satisfaction, frequency of symptoms, missed work or reduced activities days, fear avoidance beliefs, self-efficacy, pain coping strategies and kinesiophobia measured at baseline and 4, 12, 26 and 52 weeks. Linear mixed models were used to analyze outcomes. RESULTS: 201 participants were enrolled. The largest reductions in pain intensity occurred at the end of treatment and were 43% for CC and 47% for IC. The primary analysis found IC to be significantly superior to CC over the 1-year period (P = 0.02). The long-term profile for pain intensity which included data from weeks 4 through 52, showed a significant advantage of 0.5 for IC over CC (95% CI 0.1 to 0.9; P = 0.02; 0 to 10 scale). The short-term profile (weeks 4 to 12) favored IC by 0.4, but was not statistically significant (95% CI - 0.02 to 0.9; P = 0.06). There was also a significant advantage over the long term for IC in some secondary measures (disability, improvement, satisfaction and low back symptom frequency), but not for others (medication use, quality of life, leg symptom frequency, fear avoidance beliefs, self-efficacy, active pain coping, and kinesiophobia). Importantly, no serious adverse events resulted from either of the interventions. CONCLUSIONS: Participants in the IC group tended to have better outcomes than the CC group, however the magnitude of the group differences was relatively small. Given the resources required to successfully implement multidisciplinary integrative care teams, they may not be worthwhile, compared to monodisciplinary approaches like chiropractic care, for treating LBP. Trial registration NCT00567333.

Effectiveness of manual therapies: the UK evidence report.

BACKGROUND: The purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions. METHODS: The conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs), widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs not yet included in the first three categories. The strength/quality of the evidence regarding effectiveness was based on an adapted version of the grading system developed by the US Preventive Services Task Force and a study risk of bias assessment tool for the recent RCTs. RESULTS: By September 2009, 26 categories of conditions were located containing RCT evidence for the use of manual therapy: 13 musculoskeletal conditions, four types of chronic headache and nine non-musculoskeletal conditions. We identified 49 recent relevant systematic reviews and 16 evidence-based clinical guidelines plus an additional 46 RCTs not yet included in systematic reviews and guidelines.Additionally, brief references are made to other effective non-pharmacological, non-invasive physical treatments. CONCLUSIONS: Spinal manipulation/mobilization is effective in adults for: acute, subacute, and chronic low back pain; migraine and cervicogenic headache; cervicogenic dizziness; manipulation/mobilization is effective for several extremity joint conditions; and thoracic manipulation/mobilization is effective for acute/subacute neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and dysmenorrhea when compared to sham manipulation, or for Stage 1 hypertension when added to an antihypertensive diet. In children, the evidence is inconclusive regarding the effectiveness for otitis media and enuresis, and it is not effective for infantile colic and asthma when compared to sham manipulation.Massage is effective in adults for chronic low back pain and chronic neck pain. The evidence is inconclusive for knee osteoarthritis, fibromyalgia, myofascial pain syndrome, migraine headache, and premenstrual syndrome. In children, the evidence is inconclusive for asthma and infantile colic.

Spinal manipulative therapy and exercise for older adults with chronic low back pain: a randomized clinical trial.

Background: Low back pain (LBP) is a common disabling condition in older adults which often limits physical function and diminishes quality of life. Two clinical trials in older adults have shown spinal manipulative therapy (SMT) results in similar or small improvements relative to medical care; however, the effectiveness of adding SMT or rehabilitative exercise to home exercise is unclear. Methods: We conducted a randomized clinical trial assessing the comparative effectiveness of adding SMT or supervised rehabilitative exercise to home exercise in adults 65 or older with sub-acute or chronic LBP. Treatments were provided over 12-weeks and self-report outcomes were collected at 4, 12, 26, and 52 weeks. The primary outcome was pain severity. Secondary outcomes included back disability, health status, medication use, satisfaction with care, and global improvement. Linear mixed models were used to analyze outcomes. The primary analysis included longitudinal outcomes in the short (week 4-12) and long-term (week 4-52). An omnibus test assessing differences across all groups over the year was used to control for multiplicity. Secondary analyses included outcomes at each time point and responder analyses. This study was funded by the US Department of Health and Human Services, Health Resources and Services Administration. Results: 241 participants were randomized and 230 (95%) provided complete primary outcome data. The primary analysis showed group differences in pain over the one-year were small and not statistically significant. Pain severity was reduced by 30 to 40% after treatment in all 3 groups with the largest difference (eight percentage points) favoring SMT and home exercise over home exercise alone. Group differences at other time points ranged from 0 to 6 percentage points with no consistent pattern favoring one treatment. One-year post-treatment pain reductions diminished in all three groups. Secondary self-report outcomes followed a similar pattern with no important group differences, except satisfaction with care, where the two combination groups were consistently superior to home exercise alone. Conclusions: Adding spinal manipulation or supervised rehabilitative exercise to home exercise alone does not appear to improve pain or disability in the short- or long-term for older adults with chronic low back pain, but did enhance satisfaction with care. Trial registration: NCT00269321.

Outcomes of a Gratitude Practice in an Online Community of Caring.

OBJECTIVES: CaringBridge (CB) is a web-based social network where people share information, enlist support, and access resources following a difficult diagnosis; it can also be used to disseminate supportive self-care tools, such as a gratitude practice, for its users. Gratitude practices are shown to reduce stress and fear, improve sleep, and increase positive emotions and overall well-being. The purpose of this article was to report the findings of a brief gratitude intervention delivered to CB users. Design, setting/location, subjects: This is a nonrandomized, prospective, pre- and post-evaluation study in an online community. Inclusion criteria were adults 18 years or older, English literate, willingness to participate in a mind-body practice, and active users of CB: patient, caregiver, or visitor to a site. INTERVENTIONS: Participants were engaged in a daily, 21-day brief gratitude practice and were given weekly automated reminders to do their practice. OUTCOME MEASURES: Outcomes included perceived stress, gratitude, social connectedness, and social assurance scales. Paired t tests were used to assess changes in outcomes; multivariate regression models were used to assess the relationship between the frequency of gratitude practice and change in outcomes. RESULTS: Follow-up data were collected from 882/1598 participants, and nearly 70% self-reported engaging in the gratitude practice five or more days/week. Participants reported statistically significant improvement in all outcomes with small standardized effect sizes for gratitude (0.39), social connectedness (0.24), and social assurance (0.10). Changes in perceived stress (-0.73) were larger in magnitude and increased with more frequent practice. CONCLUSIONS: Among this online community, there was a high level of engagement with a brief gratitude practice, and improvements in stress, gratitude, and social support were observed. This design did not control for changes in outcomes that may be due to time trends, placebo or contextual effects, regression to the mean, or selection bias.

Short- or Long-Term Treatment of Spinal Disability in Older Adults With Manipulation and Exercise.

OBJECTIVE: Back and neck pain are associated with disability and loss of independence in older adults. Whether long-term management using commonly recommended treatments is superior to shorter-term treatment is unknown. This randomized clinical trial compared short-term treatment (12 weeks) versus long-term management (36 weeks) of back- and neck-related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE). METHODS: Eligible participants were ages ≥65 years with back and neck disability for ≥12 weeks. Coprimary outcomes were changes in Oswestry Disability Index (ODI) and Neck Disability Index (NDI) scores after 36 weeks. An intent-to-treat approach used linear mixed-model analysis to detect between-group differences. Secondary analyses included other self-reported outcomes, adverse events, and objective functional measures. RESULTS: A total of 182 participants were randomized. The short-term and long-term groups demonstrated significant improvements in back disability (ODI score -3.9 [95% confidence interval (95% CI) -5.8, -2.0] versus ODI score -6.3 [95% CI -8.2, -4.4]) and neck disability (NDI score -7.3 [95% CI -9.1, -5.5] versus NDI score -9.0 [95% CI -10.8, -7.2]) after 36 weeks, with no difference between groups (back ODI score 2.4 [95% CI -0.3, 5.1]; neck NDI score 1.7 [95% CI 0.8, 4.2]). The long-term management group experienced greater improvement in neck pain at week 36, in self-efficacy at weeks 36 and 52, and in functional ability, and balance. CONCLUSION: For older adults with chronic back and neck disability, extending management with SMT and SRE from 12 to 36 weeks did not result in any additional important reduction in disability.

Cost-effectiveness of spinal manipulation, exercise, and self-management for spinal pain using an individual participant data meta-analysis approach: a study protocol.

Background: Spinal pain is a common and disabling condition with considerable socioeconomic burden. Spine pain management in the United States has gathered increased scrutiny amidst concerns of overutilization of costly and potentially harmful interventions and diagnostic tests. Conservative interventions such as spinal manipulation, exercise and self-management may provide value for the care of spinal pain, but little is known regarding the cost-effectiveness of these interventions in the U.S. Our primary objective for this project is to estimate the incremental cost-effectiveness of spinal manipulation, exercise therapy, and self-management for spinal pain using an individual patient data meta-analysis approach. Methods/design: We will estimate the incremental cost-effectiveness of spinal manipulation, exercise therapy, and self-management using cost and clinical outcome data collected in eight randomized clinical trials performed in the U.S. Cost-effectiveness will be assessed from both societal and healthcare perspectives using QALYs, pain intensity, and disability as effectiveness measures. The eight randomized clinical trials used similar methods and included different combinations of spinal manipulation, exercise therapy, or self-management for spinal pain. They also collected similar clinical outcome, healthcare utilization, and work productivity data. A two-stage approach to individual patient data meta-analysis will be conducted. Discussion: This project capitalizes on a unique opportunity to combine clinical and economic data collected in a several clinical trials that used similar methods. The findings will provide important information on the value of spinal manipulation, exercise therapy, and self-management for spinal pain management in the U.S.

Spinal manipulation and exercise for low back pain in adolescents: a randomized trial.

Low back pain (LBP) is common in adolescence, but there is a paucity of high-quality research to inform care. We conducted a multicenter randomized trial comparing 12 weeks of spinal manipulative therapy (SMT) combined with exercise therapy (ET) to ET alone. Participants were 185 adolescents aged 12 to 18 years with chronic LBP. The primary outcome was LBP severity at 12, 26, and 52 weeks. Secondary outcomes included disability, quality of life, medication use, patient- and caregiver-rated improvement, and satisfaction. Outcomes were analyzed using longitudinal linear mixed effect models. An omnibus test assessing differences in individual outcomes over the entire year controlled for multiplicity. Of the 185 enrolled patients, 179 (97%) provided data at 12 weeks and 174 (94%) at 26 and 52 weeks. Adding SMT to ET resulted in a larger reduction in LBP severity over the course of 1 year (P = 0.007). The group difference in LBP severity (0-10 scale) was small at the end of treatment (mean difference = 0.5; P = 0.08) but was larger at weeks 26 (mean difference = 1.1; P = 0.001) and 52 (mean difference = 0.8; P = 0.009). At 26 weeks, SMT with ET performed better than ET alone for disability (P = 0.04) and improvement (P = 0.02). The SMT with ET group reported significantly greater satisfaction with care at all time points (P ≤ 0.02). There were no serious treatment-related adverse events. For adolescents with chronic LBP, spinal manipulation combined with exercise was more effective than exercise alone over a 1-year period, with the largest differences occurring at 6 months. These findings warrant replication and evaluation of cost effectiveness.

Dose-response and efficacy of spinal manipulation for care of cervicogenic headache: a dual-center randomized controlled trial.

BACKGROUND CONTEXT: The optimal number of visits for the care of cervicogenic headache (CGH) with spinal manipulative therapy (SMT) is unknown. PURPOSE: The present study aimed to identify the dose-response relationship between visits for SMT and chronic CGH outcomes and to evaluate the efficacy of SMT by comparison with a light-massage control. STUDY DESIGN/SETTING: This is a two-site, open-label randomized controlled trial. PATIENT SAMPLE: Participants were 256 adults with chronic CGH. OUTCOME MEASURES: The primary outcome was days with CGH in the previous 4 weeks evaluated at the 12- and 24-week primary end points. Secondary outcomes included CGH days at remaining end points, pain intensity, disability, perceived improvement, medication use, and patient satisfaction. METHODS: Participants were randomized to four dose levels of chiropractic SMT: 0, 6, 12, or 18 sessions. They were treated three times per week for 6 weeks and received a focused light-massage control at sessions when SMT was not assigned. Linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 24, 39, and 52 weeks. The present study was funded by the National Center for Complementary and Integrative Health (R01AT006330) and is registered at ClinicalTrials.gov (NCT01530321). The authors declare no conflicts of interest. RESULTS: A linear dose-response was observed for all follow-ups, a reduction of approximately 1 CGH day/4 weeks per additional 6 SMT visits (p<.05); a maximal effective dose could not be determined. Cervicogenic headache days/4 weeks were reduced from about 16 to 8 for the highest and most effective dose of 18 SMT visits. Mean differences in CGH days/4 weeks between 18 SMT visits and control were -3.3 (p=.004) and -2.9 (p=.017) at the primary end points, and were similar in magnitude at the remaining end points (p<.05). Differences between other SMT doses and control were smaller in magnitude (p>.05). Cervicogenic headache intensity showed no important improvement nor differed by dose. Other secondary outcomes were generally supportive of the primary outcome. CONCLUSIONS: There was a linear dose-response relationship between SMT visits and days with CGH. For the highest and most effective dose of 18 SMT visits, CGH days were reduced by half and about 3 more days per month than for the light-massage control.