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.

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.

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.

Complementary and Integrative Healthcare in a Long-term Care Facility: A Pilot Project.

INTRODUCTION: The world's population is aging quickly, leading to increased challenges of how to care for individuals who can no longer independently care for themselves. With global social and economic pressures leading to declines in family support, increased reliance is being placed on community- and government-based facilities to provide long-term care (LTC) for many of society's older citizens. Complementary and integrative healthcare (CIH) is commonly used by older adults and may offer an opportunity to enhance LTC residents' wellbeing. Little work has been done, however, rigorously examining the safety and effectiveness of CIH for LTC residents. OBJECTIVE: The goal of this work is to describe a pilot project to develop and evaluate one model of CIH in an LTC facility in the Midwestern United States. METHODS: A prospective, mixed-methods pilot project was conducted in two main phases: (1) preparation and (2) implementation and evaluation. The preparation phase entailed assessment, CIH model design and development, and training. A CIH model including acupuncture, chiropractic, and massage therapy, guided by principles of collaborative integration, evidence informed practice, and sustainability, was applied in the implementation and evaluation phase. CIH services were provided for 16 months in the LTC facility. Quantitative data collection included pain, quality of life, and adverse events. Qualitative interviews of LTC residents, their family members, and LTC staff members queried perceptions of CIH services. RESULTS: A total of 46 LTC residents received CIH care, most commonly for musculoskeletal pain (61%). Participants were predominantly female (85%) and over the age of 80 years (67%). The median number of CIH treatments was 13, with a range of 1 to 92. Residents who were able to provide self-report data demonstrated, on average, a 15% decline in pain and a 4% improvement in quality of life. No serious adverse events related to treatment were documented; the most common mild and expected side effect was increased pain (63 reports over 859 treatments). Qualitative interviews revealed most residents, family members and LTC staff members felt CIH services were worthwhile due to perceived benefits including pain relief and enhanced psychological and social wellbeing. CONCLUSION: This project demonstrated that with extensive attention to preparation, one patient-centered model of CIH in LTC was feasible on several levels. Quantitative and qualitative data suggest that CIH can be safely implemented and might provide relief and enhanced wellbeing for residents. However, some aspects of model delivery and data collection were challenging, resulting in limitations, and should be addressed in future efforts.

Introducción: La población mundial envejece con rapidez, lo cual lleva a mayores retos sobre cómo atender a individuos que no pueden cuidarse a sí mismos de manera independiente. Dado que la presión global social y económica va llevando a la disminución del apoyo a la familia, se aumenta la confianza en la comunidad y en las instalaciones respaldadas por la Administración para proporcionar atención a largo plazo a muchos de los ciudadanos mayores de la sociedad. La atención sanitaria complementaria e integral es usada por lo general por personas mayores y puede ofrecer una oportunidad para mejorar el bienestar de los residentes de atención a largo plazo. Pocos esfuerzos se han hecho, sin embargo, para examinar con rigurosidad la seguridad y efectividad de la atención sanitaria complementaria e integral para residentes de atención a largo plazo.Objetivo: El objetivo de este trabajo es describir un proyecto piloto para desarrollar y evaluar un modelo de atención sanitaria complementaria e integral en una instalación de atención a largo plazo en el Medio Oeste de los Estados Unidos.Métodos: Se llevó a cabo un proyecto piloto prospectivo, de métodos mixtos en dos fases principales: (1) preparación e (2) implementación y evaluación. La fase de preparación conlleva la valoración, el diseño y desarrollo del modelo de atención sanitaria complementaria e integral, y la formación. Se aplicó un modelo de atención sanitaria complementaria e integral que incluye acupuntura, quiropráctica y terapia de masaje, según los principios de integración colaboradora, práctica informada según evidencias y sostenibilidad en las fases de implementación y evaluación. Los servicios de atención sanitaria complementaria e integral se proporcionaron durante 16 meses en la instalación de atención a largo plazo. La recolección de datos cuantitativos incluyó los relativos al dolor, calidad de vida y acontecimientos adversos. Las percepciones de los servicios de atención sanitaria complementaria e integral se indagaron mediante entrevistas cualitativas de los residentes de atención a largo plazo, sus familiares y los miembros del personal.resultados: Un total de 46 residentes de atención a largo plazo recibieron atención sanitaria complementaria e integral, sobre todo por dolor musculoesquelético (61%). Los participantes fueron predominantemente mujeres (85%) y mayores de 80 años (67%). El número medio de tratamientos de atención sanitaria complementaria e integral fue de 13, con un rango de 1 a 92. Los residentes capaces de proporcionar datos propios por sí mismos mostraron, de media, un 15% de disminución del dolor y un 4% de mejora de calidad de vida. No se documentaron acontecimientos adversos graves relacionados con el tratamiento; el efecto secundario más común, leve y esperado fue el de aumento del dolor (63 notificaciones de 859 tratamientos). Las entrevistas cualitativas revelaron que la mayoría de los residentes, familiares y miembros del personal de atención a largo plazo opinaron que los servicios de atención sanitaria complementaria e integral merecen la pena debido a los beneficios percibidos, incluyendo el alivio del dolor y la mejora del bienestar psicológico y social.Conclusión: El proyecto demostró que, con una gran atención en la preparación, un modelo centrado en el paciente de atención sanitaria complementaria e integral en atención a largo plazo era viable a varios niveles. Los datos cuantitativos y cualitativos sugieren que la atención sanitaria complementaria e integral puede implementarse con seguridad y podría proporcionar alivio y bienestar acentuado a los residentes. Sin embargo, algunos aspectos de la presentación del modelo y la recopilación de datos fueron un reto, dando lugar a limitaciones, que deberían afrontarse en futuros intentos.

Short term treatment versus long term management of neck and back disability in older adults utilizing spinal manipulative therapy and supervised exercise: a parallel-group randomized clinical trial evaluating relative effectiveness and harms.

BACKGROUND: Back and neck disability are frequent in older adults resulting in loss of function and independence. Exercise therapy and manual therapy, like spinal manipulative therapy (SMT), have evidence of short and intermediate term effectiveness for spinal disability in the general population and growing evidence in older adults. For older populations experiencing chronic spinal conditions, long term management may be more appropriate to maintain improvement and minimize the impact of future exacerbations. Research is limited comparing short courses of treatment to long term management of spinal disability. The primary aim is to compare the relative effectiveness of 12 weeks versus 36 weeks of SMT and supervised rehabilitative exercise (SRE) in older adults with back and neck disability. METHODS/DESIGN: Randomized, mixed-methods, comparative effectiveness trial conducted at a university-affiliated research clinic in the Minneapolis/St. Paul, Minnesota metropolitan area. PARTICIPANTS: Independently ambulatory community dwelling adults ≥ 65 years of age with back and neck disability of minimum 12 weeks duration (n = 200). INTERVENTIONS: 12 weeks SMT + SRE or 36 weeks SMT + SRE. RANDOMIZATION: Blocked 1:1 allocation; computer generated scheme, concealed in sequentially numbered, opaque, sealed envelopes. BLINDING: Functional outcome examiners are blinded to treatment allocation; physical nature of the treatments prevents blinding of participants and providers to treatment assignment. PRIMARY ENDPOINT: 36 weeks post-randomization. DATA COLLECTION: Self-report questionnaires administered at 2 baseline visits and 4, 12, 24, 36, 52, and 78 weeks post-randomization. Primary outcomes include back and neck disability, measured by the Oswestry Disability Index and Neck Disability Index. Secondary outcomes include pain, general health status, improvement, self-efficacy, kinesiophobia, satisfaction, and medication use. Functional outcome assessment occurs at baseline and week 37 for hand grip strength, short physical performance battery, and accelerometry. Individual qualitative interviews are conducted when treatment ends. Data on expectations, falls, side effects, and adverse events are systematically collected. PRIMARY ANALYSIS: Linear mixed-model method for repeated measures to test for between-group differences with baseline values as covariates. DISCUSSION: Treatments that address the management of spinal disability in older adults may have far reaching implications for patient outcomes, clinical guidelines, and healthcare policy. TRIAL REGISTRY: www.ClinicalTrials.gov; Identifier: NCT01057706.

Integrative care for the management of low back pain: use of a clinical care pathway.

BACKGROUND: For the treatment of chronic back pain, it has been theorized that integrative care plans can lead to better outcomes than those achieved by monodisciplinary care alone, especially when using a collaborative, interdisciplinary, and non-hierarchical team approach. This paper describes the use of a care pathway designed to guide treatment by an integrative group of providers within a randomized controlled trial. METHODS: A clinical care pathway was used by a multidisciplinary group of providers, which included acupuncturists, chiropractors, cognitive behavioral therapists, exercise therapists, massage therapists and primary care physicians. Treatment recommendations were based on an evidence-informed practice model, and reached by group consensus. Research study participants were empowered to select one of the treatment recommendations proposed by the integrative group. Common principles and benchmarks were established to guide treatment management throughout the study. RESULTS: Thirteen providers representing 5 healthcare professions collaborated to provide integrative care to study participants. On average, 3 to 4 treatment plans, each consisting of 2 to 3 modalities, were recommended to study participants. Exercise, massage, and acupuncture were both most commonly recommended by the team and selected by study participants. Changes to care commonly incorporated cognitive behavioral therapy into treatment plans. CONCLUSION: This clinical care pathway was a useful tool for the consistent application of evidence-based care for low back pain in the context of an integrative setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT00567333.

Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach.

BACKGROUND: Low back pain (LBP) is a prevalent and costly condition in the United States. Evidence suggests there is no one treatment which is best for all patients, but instead several viable treatment options. Additionally, multidisciplinary management of LBP may be more effective than monodisciplinary care. An integrative model that includes both complementary and alternative medicine (CAM) and conventional therapies, while also incorporating patient choice, has yet to be tested for chronic LBP.The primary aim of this study is to determine the relative clinical effectiveness of 1) monodisciplinary chiropractic care and 2) multidisciplinary integrative care in 200 adults with non-acute LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome measure is patient-rated back pain. Secondary aims compare the treatment approaches in terms of frequency of symptoms, low back disability, fear avoidance, self-efficacy, general health status, improvement, satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods, and cost-effectiveness and cost utility will be assessed. METHODS AND DESIGN: This paper describes the design of a randomized clinical trial (RCT), with cost-effectiveness and qualitative studies conducted alongside the RCT. Two hundred participants ages 18 and older are being recruited and randomized to one of two 12-week treatment interventions. Patient-rated outcome measures are collected via self-report questionnaires at baseline, and at 4, 12, 26, and 52 weeks post-randomization. Objective outcome measures are assessed at baseline and 12 weeks by examiners blinded to treatment assignment. Health care cost data is collected by self-report questionnaires and treatment records during the intervention phase and by monthly phone interviews thereafter. Qualitative interviews, using a semi-structured format, are conducted with patients at the end of the 12-week treatment period and also with providers at the end of the trial. DISCUSSION: This mixed-methods randomized clinical trial assesses clinical effectiveness, cost-effectiveness, and patients' and providers' perceptions of care, in treating non-acute LBP through evidence-based individualized care delivered by monodisciplinary or multidisciplinary care teams. TRIAL REGISTRATION: ClinicalTrials.gov NCT00567333.