Predictive Validity of the STarT Back Tool for Risk of Persistent Disabling Back Pain in a U.S. Primary Care Setting.

OBJECTIVE: To examine the predictive validity of the Subgrouping for Targeted Treatment (STarT Back) tool for classifying people with back pain into categories of low, medium, and high risk of persistent disabling back pain in U.S. primary care. DESIGN: Secondary analysis of data from participants receiving usual care in a randomized clinical trial. SETTING: Primary care clinics. PARTICIPANTS: Adults (N = 1109) ≥18 years of age with back pain. Those with specific causes of back pain (pregnancy, disc herniation, vertebral fracture, spinal stenosis) and work-related injuries were not included. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The original 9-item version of the STarT Back tool, administered at baseline, stratified patients by their risk (low, medium, high) of persistent disabling back pain (STarT Back risk group). Persistent disabling back pain was defined as Roland-Morris Disability Questionnaire scores of ≥7 at 6-month follow-up. RESULTS: The STarT Back risk group was a significant predictor of persistent disabling back pain (P<.0001) at 6-month follow-up. The proportion of individuals with persistent disabling back pain at follow-up was 22% (95% confidence interval [CI] 18-25) in the low-risk group, 62% (95% CI 57-67) in the medium-risk group, and 80% (95% CI 75-85) in the high-risk group. The relative risk of persistent disabling back pain was 2.9 (95% CI 2.4-3.5) in the medium-risk group compared to the low-risk group, and 3.7 (95% CI 3.1-4.4) in the high-risk group. CONCLUSIONS: The STarT Back risk groups successfully separated people with back pain into distinct categories of risk for persistent disabling back pain at 6-month follow-up in U.S. primary care. These results were very similar to those in the original STarT Back validation study. This validation study is a necessary first step toward identifying whether the entire STarT Back approach, including matched/targeted treatment, can be effectively used for primary care in the United States.

A comparison of the effects of 2 types of massage and usual care on chronic low back pain: a randomized, controlled trial.

BACKGROUND: Few studies have evaluated the effectiveness of massage for chronic low back pain. OBJECTIVE: To compare the effectiveness of 2 types of massage and usual care for chronic back pain. DESIGN: Parallel-group randomized, controlled trial. Randomization was computer-generated, with centralized allocation concealment. Participants were blinded to massage type but not to assignment to massage versus usual care. Massage therapists were unblinded. The study personnel who assessed outcomes were blinded to treatment assignment. (ClinicalTrials.gov registration number: NCT00371384) SETTING: An integrated health care delivery system in the Seattle area. PATIENTS: 401 persons 20 to 65 years of age with nonspecific chronic low back pain. INTERVENTION: Structural massage (n = 132), relaxation massage (n = 136), or usual care (n = 133). MEASUREMENTS: Roland Disability Questionnaire (RDQ) and symptom bothersomeness scores at 10 weeks (primary outcome) and at 26 and 52 weeks (secondary outcomes). Mean group differences of at least 2 points on the RDQ and at least 1.5 points on the symptom bothersomeness scale were considered clinically meaningful. RESULTS: The massage groups had similar functional outcomes at 10 weeks. The adjusted mean RDQ score was 2.9 points (95% CI, 1.8 to 4.0 points) lower in the relaxation group and 2.5 points (CI, 1.4 to 3.5 points) lower in the structural massage group than in the usual care group, and adjusted mean symptom bothersomeness scores were 1.7 points (CI, 1.2 to 2.2 points) lower with relaxation massage and 1.4 points (CI, 0.8 to 1.9 points) lower with structural massage. The beneficial effects of relaxation massage on function (but not on symptom reduction) persisted at 52 weeks but were small. LIMITATION: Participants were not blinded to treatment. CONCLUSION: Massage therapy may be effective for treatment of chronic back pain, with benefits lasting at least 6 months. No clinically meaningful difference between relaxation and structural massage was observed in terms of relieving disability or symptoms. PRIMARY FUNDING SOURCE: National Center for Complementary and Alternative Medicine.

Urinary incontinence in US women: a population-based study.

BACKGROUND: Urinary incontinence (UI) is a common disorder that is increasingly important as our population ages. Less is known about UI in younger women, and few large surveys have been able to determine risk factors by linking their data to patients' medical findings. METHODS: We conducted a population-based, age-stratified postal survey of 6000 women aged between 30 and 90 years who were enrolled in a large health maintenance organization in Washington State. RESULTS: The response rate was 64% (n = 3536) after exclusion criteria were applied. The population-based prevalence of UI was 45%. Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women. Eighteen percent of respondents reported severe UI. The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women. Older age, higher body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters), greater medical comorbidity, current major depression, a history of hysterectomy, and parity increased the odds of having UI. Not being white and having had only cesarean deliveries decreased the odds of having UI. Major depression (odds ratio, 2.48; 95% confidence interval, 1.65-3.72) and obesity, defined as having a BMI of 30 or greater (odds ratio, 2.39; 95% confidence interval, 1.99-2.87), had the strongest association with UI. Among women with UI, age, BMI, medical comorbidity, current major depression, diabetes, a history of hysterectomy, and having had only cesarean deliveries were significantly associated with severe UI. CONCLUSIONS: Urinary incontinence is highly prevalent in women across their adult life span, and its severity increases linearly with age. Age, BMI, race, medical comorbidity, current major depression, a history of hysterectomy, parity, and having only had cesarean deliveries are each independent factors significantly associated with the likelihood of having UI.

Incontinence severity and major depression in incontinent women.

OBJECTIVE: Research has shown an association between urinary incontinence and depression. Studies that use community-based samples and major depressive disorder diagnostic criteria are needed. The objective of this study was to estimate the prevalence of and factors associated with major depression in women with urinary incontinence. METHODS: We conducted an age-stratified postal survey of 6,000 women aged 30-90 years. Subjects were randomly selected from enrollees in a large health maintenance organization in Washington state. Main outcome measures were prevalence of current major depression and adjusted odds ratios for factors associated with major depression in women with urinary incontinence. RESULTS: The response rate was 64% (n = 3,536) after applying exclusion criteria. The prevalence of urinary incontinence was 42% (n = 1,458). The prevalence of major depression was 3.7% (n = 129), with 2.2% in those without incontinence versus 6.1% in those with incontinence. Among women with incontinence, major depression prevalence rates differed by incontinence severity (2.1% in mild, 5.7% in moderate, and 8.3% in severe) and incontinence type (4.7% in stress, 6.6% in urge/mixed). Obesity (odds ratio [OR] 2.3, 95% confidence interval [CI] 1.3-4.0), current smoking (OR 2.7, 95% CI 1.5-4.9), lower educational attainment (OR 2.0, 95% CI 1.2-3.3), moderate incontinence (OR 2.7, 95% CI 1.1-6.6), and severe incontinence (OR 3.8, 95% CI 1.6-9.1) were each associated with increased odds of major depression in women with urinary incontinence, controlling for age and medical comorbidity. Compared with women with incontinence alone, women with comorbid incontinence and major depression had significantly greater decrements in quality of life and functional status and increased incontinence symptom burden. CONCLUSION: Women with moderate-to-severe urinary incontinence should be screened for comorbid major depression and offered treatment if depression is present. LEVEL OF EVIDENCE: II-2.

A randomized trial comparing yoga, stretching, and a self-care book for chronic low back pain.

BACKGROUND: Chronic low back pain is a common problem lacking highly effective treatment options. Small trials suggest that yoga may have benefits for this condition. This trial was designed to determine whether yoga is more effective than conventional stretching exercises or a self-care book for primary care patients with chronic low back pain. METHODS: A total of 228 adults with chronic low back pain were randomized to 12 weekly classes of yoga (92 patients) or conventional stretching exercises (91 patients) or a self-care book (45 patients). Back-related functional status (modified Roland Disability Questionnaire, a 23-point scale) and bothersomeness of pain (an 11-point numerical scale) at 12 weeks were the primary outcomes. Outcomes were assessed at baseline, 6, 12, and 26 weeks by interviewers unaware of treatment group. RESULTS: After adjustment for baseline values, 12-week outcomes for the yoga group were superior to those for the self-care group (mean difference for function, -2.5 [95% CI, -3.7 to -1.3]; P < .001; mean difference for symptoms, -1.1 [95% CI, -1.7 to -0.4]; P < .001). At 26 weeks, function for the yoga group remained superior (mean difference, -1.8 [95% CI, -3.1 to -0.5]; P < .001). Yoga was not superior to conventional stretching exercises at any time point. CONCLUSION: Yoga classes were more effective than a self-care book, but not more effective than stretching classes, in improving function and reducing symptoms due to chronic low back pain, with benefits lasting at least several months. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00447668.

Treatment expectations and preferences as predictors of outcome of acupuncture for chronic back pain.

STUDY DESIGN: Preplanned secondary analysis of data from participants receiving acupuncture in a randomized clinical trial. OBJECTIVE: To determine whether patients' expectations of and preferences for acupuncture predict short and long-term treatment outcomes for persons with chronic back pain. SUMMARY OF BACKGROUND DATA: Although accumulating evidence suggests that patient expectations and treatment preferences may predict treatment outcomes, few studies have examined this relationship for acupuncture. METHODS: Four hundred seventy-seven acupuncture-naïve participants with chronic low back pain who were randomized to 1 of 3 acupuncture or simulated acupuncture treatments were the focus of this analysis. Ten treatments were provided during a 7-week period, and participants were masked to treatment assignment. Before randomization, participants provided expectations regarding treatment success, impressions, and knowledge about acupuncture and treatment preferences. Outcomes of interest were functional status (Roland score) and symptom bothersomeness at 8 and 52 weeks postrandomization, obtained by telephone interviewers masked to treatment assignment. RESULTS: Persons with high pretreatment expectations for the success of acupuncture were more likely to report greater general expectations for improvement, a preference for acupuncture, having heard acupuncture was a very effective treatment and having a very or moderately positive impression of acupuncture. However, none of these variables was a significant predictor of improvement in back-related symptoms or function at 8 or 52 weeks. After 1 treatment, participants' revised expectations of treatment success were only associated with back-symptoms at the end of treatment. After 5 treatments, revised expectation of success was predictive of both symptoms and function at 8 and 52 weeks. CONCLUSION: Pretreatment expectations and preferences for acupuncture were not found predictive of treatment outcomes for patients with chronic back pain. These results differ from previous studies evaluating acupuncture for chronic back pain. These inconsistent results suggest that the relationship between expectations and outcomes may be more complex than previously believed.

A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain.

BACKGROUND: Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. METHODS: A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale). Outcomes were assessed at baseline and after 8, 26, and 52 weeks. RESULTS: At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P < .001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs 39%; P < .001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P < .001). After 1 year, participants in the treatment groups were more likely than those receiving usual care to experience clinically meaningful improvements in dysfunction (59% to 65% vs 50%, respectively; P = .02) but not in symptoms (P > .05). CONCLUSIONS: Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects.

Hepatitis B vaccine and risk of autoimmune thyroid disease: a Vaccine Safety Datalink study.

PURPOSE: Hepatitis B vaccine has been postulated as a possible cause of autoimmune disorders, including autoimmune thyroid diseases (ATD). Cases of Graves' disease and Hashimoto's thyroiditis, following hepatitis B vaccine have been reported to the Vaccine Adverse Events Reporting System (VAERS). To test the hypothesis that hepatitis B vaccine increases the risk of ATD, we conducted a case-control study, within the Vaccine Safety Datalink project. METHODS: We identified potential cases of Graves' disease and Hashimoto's thyroiditis, among persons aged 18-69 years from administrative data recorded by three health maintenance organizations (HMOs) and verified cases by medical record review. Controls were frequency-matched to cases by birth year, sex, and study site. Vaccine information was collected from administrative records, chart review, and telephone interviews with study subjects. We enrolled 355 Graves' disease cases, 418 Hashimoto's thyroiditis cases, and 1102 controls. We assessed the association between ever-receipt of hepatitis B vaccine, as well as receipt of hepatitis B vaccine less than 1 year, 1-5 years and at least 5 years prior to the index date, and the risk of ATD. RESULTS: Ever-receipt of hepatitis B vaccine was not associated with risk of Graves' disease (odds ratio (OR), 0.90; 95% confidence interval (CI), 0.62-1.32) or Hashimoto's thyroiditis (OR, 1.23; 95%CI, 0.87-1.73). There was also no association between the time interval since receipt of hepatitis B vaccination and either outcome. CONCLUSIONS: We did not observe an increased risk of Graves' disease or Hashimoto's thyroiditis, following receipt of hepatitis B vaccine.