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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>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.</p> <p>Methods and Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>ClinicalTrials.gov NCT00567333</p

Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial

<p>Abstract</p> <p>Background</p> <p>Back-related leg pain (BRLP) is a common variation of low back pain (LBP), with lifetime prevalence estimates as high as 40%. Often disabling, BRLP accounts for greater work loss, recurrences, and higher costs than uncomplicated LBP and more often leads to surgery with a lifetime incidence of 10% for those with severe BRLP, compared to 1-2% for those with LBP.</p> <p>In the US, half of those with back-related conditions seek CAM treatments, the most common of which is chiropractic care. While there is preliminary evidence suggesting chiropractic spinal manipulative therapy is beneficial for patients with BRLP, there is insufficient evidence currently available to assess the effectiveness of this care.</p> <p>Methods/Design</p> <p>This study is a two-site, prospective, parallel group, observer-blinded randomized clinical trial (RCT). A total of 192 study patients will be recruited from the Twin Cities, MN (n = 122) and Quad Cities area in Iowa and Illinois (n = 70) to the research clinics at WHCCS and PCCR, respectively.</p> <p>It compares two interventions: chiropractic spinal manipulative therapy (SMT) plus home exercise program (HEP) to HEP alone (minimal intervention comparison) for patients with subacute or chronic back-related leg pain.</p> <p>Discussion</p> <p>Back-related leg pain (BRLP) is a costly and often disabling variation of the ubiquitous back pain conditions. As health care costs continue to climb, the search for effective treatments with few side-effects is critical. While SMT is the most commonly sought CAM treatment for LBP sufferers, there is only a small, albeit promising, body of research to support its use for patients with BRLP.</p> <p>This study seeks to fill a critical gap in the LBP literature by performing the first full scale RCT assessing chiropractic SMT for patients with sub-acute or chronic BRLP using important <b>patient-oriented </b>and <b>objective biomechanical </b>outcome measures.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT00494065">NCT00494065</a></p

Early risk factors for lumbar discectomy: an 11-year follow-up of 57,408 adolescents

There is a lack of longitudinal studies on the risk factors of lumbar discectomy. Using combined population survey and hospital discharge register data in a prospective longitudinal design, we investigated the association between adolescent risk factors and lumbar discectomy until early middle age. A prospective cohort of health survey respondents (n = 57,408) aged 14–18 years was followed for 651,000 person-years (average follow-up, 11.3 years). Study endpoints were lumbar discectomy, death or end of follow-up. Participants’ mean age at the end of follow-up was 27 years. In multivariate Cox’s regression analysis, the significant risk factor for lumbar discectomy among male respondents was daily smoking, HR being 1.5 (95% CI 1.1–2.2). In females, frequent participation in sports clubs (HR 2.7, 95% CI 1.1–6.3) and overweight (HR 2.1; 95% CI 1.1–4.1) were significantly associated with an increased risk of lumbar discectomy. Daily smoking in males and frequent participation in sports clubs and overweight in females measured at adolescence were statistically associated with lumbar discectomy at an 11-year follow-up, although the hazard ratios were relatively small. Further study of these common risk factors and their modifications may lead to a better understanding of the causes of lumbar disc herniation

Diagnosis and conservative management of degenerative lumbar spondylolisthesis

Degenerative spondylolisthesis (DS) is a disorder that causes the slip of one vertebral body over the one below due to degenerative changes in the spine. Lumbar DS is a major cause of spinal canal stenosis and is often related to low back and leg pain. We reviewed the symptoms, prognosis and conservative treatments for symptoms associated with DS. PubMed and MEDLINE databases (1950–2007) were searched for the key words “spondylolisthesis”, “pseudospondylolisthesis”, “degenerative spondylolisthesis”, “spinal stenosis”, “lumbar spine”, “antherolisthesis”, “posterolisthesis”, “low back pain”, and “lumbar instability”. All relevant articles in English were reviewed. Pertinent secondary references were also retrieved. The prognosis of patients with DS is favorable, however, those who suffer from neurological symptoms such as intermittent claudication or vesicorectal disorder, will most probably experience neurological deterioration if they are not operated upon. Nonoperative treatment should be the initial course of action in most cases of DS, with or without neurologic symptoms. Treatment options include use of analgesics and NSAIDs to control pain; epidural steroid injections, and physical methods such as bracing and flexion strengthening exercises. An up-to-date knowledge on diagnosis and prevention of lumbar DS can assist in determination of future research goals. Additional studies are required to establish treatment protocols for the conservative treatment of DS

Reabilitação precoce de atletas utilizando hidroterapia após o tratamento cirúrgico de hérnia discal lombar: relato preliminar de 3 casos Early rehabilitation of athletes using hydrotherapy after surgical treatment of lumbar disc herniation: preliminary report of three cases

Os autores avaliaram três atletas do sexo masculino, submetidos a tratamento cirúrgico de hérnia discal lombar, com o objetivo de avaliar os resultados, após serem submetidos a um protocolo de reabilitação com base em hidroterapia. Este método permitiu a reabilitação precoce dos atletas, iniciando-se na primeira semana após a cirurgia. Os atletas foram avaliados em 5 ocasiões: pré-operatório e nos 4 meses seguintes. Houve melhora completa da dor em dois atletas. O terceiro caso apresentou no 4º mês 1,3% da intensidade máxima. As atividades de vida diária no período pré-operatório em média apresentaram-se com 21,6% da freqüência máxima, chegando a 99,3% no 4º mês. A freqüência de prática esportiva teve em média 10% da intensidade no pré-operatório, no 4º mês os atletas já praticavam a atividade esportiva com uma freqüência de 84,6% do normal. O nível de atividade esportiva foi relatado em média como 10% daquele estabelecido pelos atletas antes do início dos sintomas, atingindo 88,3% no 4º mês. Concluímos que os atletas apresentaram melhora evolutiva em todos os parâmetros analisados, especialmente em relação a dor. Portanto, a hidroterapia mostrou-se um método eficaz e bem tolerado na reabilitação precoce da cirurgia de hérnia discal em atletas.<br>Three male athletes submitted to surgical treatment of lumbar disc herniation were assessed aiming to evaluate the results of a rehabilitation protocol based on aquatic therapy. This method allowed early rehabilitation of the athletes, within a week after surgery. The athletes were evaluated in 5 occasions: pre-operatively and in the 4 following months. Complete improvement of pain was observed in two athletes. The third case had 1.3% of the maximum intensity in the 4th month. The daily life activities during the pre-operative period presented 21.6% of the maximum frequency on average, reaching 99.3% in the 4th month. The frequency of practicing sports was on average 10% the pre-operative intensity; in the 4th month the athletes already played sports with a frequency 84.6% of the normal. The level of sporting activities was reported as 10% on average of the one established by the athletes before the symptoms had started, reaching 88.3% in the 4th month. We conclude that the athletes had an evolutionary improvement in all the analyzed parameters, especially as regards pain. Thus, hydrotherapy was an effective and well tolerated method in the early rehabilitation of athletes after disc herniation surgery