Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial.

BACKGROUND: Mechanical neck pain is a common condition that affects an estimated 70% of persons at some point in their lives. Little research exists to guide the choice of therapy for acute and subacute neck pain. OBJECTIVE: To determine the relative efficacy of spinal manipulation therapy (SMT), medication, and home exercise with advice (HEA) for acute and subacute neck pain in both the short and long term. DESIGN: Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00029770) SETTING: 1 university research center and 1 pain management clinic in Minnesota. PARTICIPANTS: 272 persons aged 18 to 65 years who had nonspecific neck pain for 2 to 12 weeks. INTERVENTION: 12 weeks of SMT, medication, or HEA. MEASUREMENTS: The primary outcome was participant-rated pain, measured at 2, 4, 8, 12, 26, and 52 weeks after randomization. Secondary measures were self-reported disability, global improvement, medication use, satisfaction, general health status (Short Form-36 Health Survey physical and mental health scales), and adverse events. Blinded evaluation of neck motion was performed at 4 and 12 weeks. RESULTS: For pain, SMT had a statistically significant advantage over medication after 8, 12, 26, and 52 weeks (P ≤ 0.010), and HEA was superior to medication at 26 weeks (P = 0.02). No important differences in pain were found between SMT and HEA at any time point. Results for most of the secondary outcomes were similar to those of the primary outcome. LIMITATIONS: Participants and providers could not be blinded. No specific criteria for defining clinically important group differences were prespecified or available from the literature. CONCLUSION: For participants with acute and subacute neck pain, SMT was more effective than medication in both the short and long term. However, a few instructional sessions of HEA resulted in similar outcomes at most time points. PRIMARY FUNDING SOURCE: National Center for Complementary and Alternative Medicine, National Institutes of Health.

Does Vitamin D Provide Added Benefit to Antihypertensive Therapy in Reducing Left Ventricular Hypertrophy Determined by Cardiac Magnetic Resonance?

BACKGROUND: Left ventricular hypertrophy (LVH) and vitamin D deficiency have been linked to hypertension (HTN) and cardiovascular disease, particularly in African Americans (AAs). Our objective was to determine if the addition of vitamin D to antihypertensive therapy would lead to greater regression of LV mass index (LVMI) as determined by cardiac magnetic resonance (CMR) after 1 year in vitamin D deficient AA patients with uncontrolled HTN and LVH. METHODS: This study was a randomized, double-blind, placebo-controlled, single-center study. AA patients with HTN (systolic blood pressure [BP] >160 mm Hg), increased LVMI, and vitamin D deficiency (<20 ng/ml) were randomized. All patients received antihypertensive therapy combined with biweekly 50,000 IU vitamin D3 (vitamin D group, n = 55) or placebo (placebo group, n = 58). RESULTS: At 1 year, there were no statistical differences between the vitamin D and placebo groups in LVMI (-14.1 ± 14.6 vs. -16.9 ± 13.1 g/m2; P = 0.34) or systolic BP (-25.6 ± 32.1 vs. -25.7 ± 25.6 mm Hg; P = 0.99) reduction, respectively. Serum vitamin D levels increased significantly in the vitamin D group compared with placebo (12.7 ± 2.0 vs. 1.8 ± 8.2 ng/ml; P < 0.001). CONCLUSIONS: In this high-risk cohort of AAs we did not find an association between vitamin D supplementation and differential regression of LVMI or reduction in systolic BP. However, our study suffered from a small sample size with low statistical power precluding a definitive conclusion on the therapeutic benefit of vitamin D in such patients. CLINICAL TRIALS REGISTRATION: Trial Number NCT01360476. Full trial protocol is available from corresponding author.

Incidence of type 2 diabetes in the randomized multiple risk factor intervention trial.

BACKGROUND: Weight loss and increased physical exercise reduce the risk for diabetes in people with impaired glucose tolerance. Randomized trial evidence on the effect of these interventions on people without impaired glucose tolerance is lacking. OBJECTIVE: To examine the influence of a comprehensive intervention program on the risk for developing diabetes in men without impaired glucose tolerance and in a post hoc subgroup analysis by baseline cigarette smoking status. DESIGN: Randomized, controlled trial. SETTING: 22 clinical centers for the Multiple Risk Factor Intervention Trial (MRFIT). PARTICIPANTS: 12,866 men age 35 to 57 years at risk for cardiovascular disease were randomly assigned to either a special intervention or usual care group and followed for 6 to 7 years; this report focuses on 11,827 men without diabetes or impaired glucose tolerance at entry for whom follow-up glucose measurements were available. MEASUREMENTS: Cardiovascular disease risk factors, fasting blood glucose levels, and diabetes medication history were assessed before randomization and annually. INTERVENTION: Men in the special intervention group were counseled to change diet (reduce saturated fat, cholesterol, and calorie intake), to stop smoking, and to increase physical activity. Blood pressure was treated more intensively in the special intervention group than in the usual care group. RESULTS: 11.5% of the special intervention group and 10.8% of the usual care group developed diabetes over 6 years of follow-up (hazard ratio, 1.08 [95% CI, 0.96 to 1.20]). The special intervention-usual care hazard ratio for diabetes was 1.26 (CI, 1.10 to 1.45) among smokers (63%) and 0.82 (CI, 0.68 to 0.98) among nonsmokers (37%). These estimates differed significantly (P = 0.0003). Weight gain after smoking cessation and the use of antihypertensive drugs may have counterbalanced the beneficial effect of the lifestyle intervention for the special intervention group smokers, while the lifestyle intervention was beneficial among nonsmokers. LIMITATIONS: Principal findings are based on a post hoc subgroup analysis. CONCLUSIONS: In nonsmokers, an intervention program that included nutrition counseling to produce reductions in weight, serum cholesterol, and (along with antihypertensive medication) blood pressure reduced the risk for diabetes.

Patient visits to a hospital-based alternative medicine clinic from 1997 through 2002: experience from an integrated healthcare system.

OBJECTIVE: Efforts to integrate complementary and alternative medicine (CAM) into conventional healthcare systems raise questions about expected levels of CAM use and its cost in an integrated system. This paper documents actual patient usage of a hospital-based alternative medicine clinic that has been operating on a conventional healthcare campus since 1993. SETTING: Hennepin Faculty Associates (HFA) is a multispecialty physician organization serving the Hennepin County Medical Center (HCMC), a public teaching hospital in downtown Minneapolis. In 1993, HFA opened an alternative medicine clinic, primarily providing acupuncture. The clinic has since expanded services to offer chiropractic, massage/bodywork, and herbs. Administrative claims data showing visit dates, treatment received, payment source, charges, and patient complaints are available from 1997 through 2002. RESULTS: Of all HFA patients who received conventional care on the HCMC campus every year (1997-2002), 6.5% also received care at the Alternative Medicine Clinic (AMC). Nearly 80% of AMC patients received third-party reimbursement for AMC services. Averaged over 6 years, self-pay patients had 3.2 visits per year and incurred $173 in charges per year; patients with a mixture of third-party payment sources had 8.0 visits per year and incurred $634 in charges per year. Number of visits per patient per year remained relatively constant over the 6 years, except for patients aged 65 or older, who showed an increase in number of visits, particularly for acupuncture. CONCLUSIONS: This report contributes a new perspective on use of CAM in the general population. Results from this perspective differ markedly from those provided by published survey data, showing a lower prevalence of use and lower charges incurred. Concern that insurance coverage for CAM would increase healthcare costs dramatically are not substantiated by these data.

Should intrathecal narcotics be used as a sole labor analgesic? A prospective comparison of spinal opioids and epidural bupivacaine.

OBJECTIVE: Intrathecal narcotics (ITNs) are being used in some settings as a sole labor analgesic. However, they have not been directly compared to epidural analgesia. STUDY DESIGN: We used a prospective observational design. POPULATION: Eighty-two women with uncomplicated full-term pregnancies were enrolled upon analgesia request during spontaneous labor with cervical dilation 3 to 7 cm. Sixty-three chose ITNs (morphine and fentanyl), and 19 chose epidural analgesia (continuous infusion of bupivacaine and fentanyl). OUTCOMES MEASURED: Pain scores were documented using a visual analog scale. Satisfaction and side effects were rated with Likert scales during a structured interview on the first postpartum day. Outcomes were analyzed with multivariate regression techniques. RESULTS: Intrathecal narcotics were associated with significantly higher pain scores than was epidural analgesia during the first and second stages of labor and on an overall postpartum rating. The median effective duration of action for ITNs was between 60 and 120 minutes; however, ITNs provided excellent analgesia for a subgroup of women who delivered within 2 to 3 hours of receiving them. Although women in both groups were satisfied with their pain management, women receiving ITNs had statistically lower overall satisfaction scores. CONCLUSIONS: Within the limitations of a nonrandomized study, a single intrathecal injection of morphine and fentanyl has a shorter duration of action and provides less effective pain control than a continuous epidural infusion of bupivacaine and fentanyl. However, ITNs may have a role in settings with limited support from anesthesiologists or for women whose labors are progressing rapidly.

Spinal manipulative therapy and exercise for seniors with chronic neck pain.

BACKGROUND CONTEXT: Neck pain, common among the elderly population, has considerable implications on health and quality of life. Evidence supports the use of spinal manipulative therapy (SMT) and exercise to treat neck pain; however, no studies to date have evaluated the effectiveness of these therapies specifically in seniors. PURPOSE: To assess the relative effectiveness of SMT and supervised rehabilitative exercise, both in combination with and compared to home exercise (HE) alone for neck pain in individuals ages 65 years or older. STUDY DESIGN/SETTING: Randomized clinical trial. PATIENT SAMPLE: Individuals 65 years of age or older with a primary complaint of mechanical neck pain, rated ≥3 (0-10) for 12 weeks or longer in duration. OUTCOME MEASURES: Patient self-report outcomes were collected at baseline and 4, 12, 26, and 52 weeks after randomization. The primary outcome was pain, measured by an 11-box numerical rating scale. Secondary outcomes included disability (Neck Disability Index), general health status (Medical Outcomes Study Short Form-36), satisfaction (7-point scale), improvement (9-point scale), and medication use (days per week). METHODS: This study was funded by the US Department of Health and Human Services, Health Resources and Services Administration. Linear mixed model analyses were used for comparisons at individual time points and for short- and long-term analyses. Blinded evaluations of objective outcomes were performed at baseline and 12 weeks. Adverse event data were collected at each treatment visit. RESULTS: A total of 241 participants were randomized, with 95% reporting primary outcome data at all time points. After 12 weeks of treatment, the SMT with home exercise group demonstrated a 10% greater decrease in pain compared with the HE-alone group, and 5% change over supervised plus home exercise. A decrease in pain favoring supervised plus HE over HE alone did not reach statistical significance. Compared with the HE group, both combination groups reported greater improvement at week 12 and more satisfaction at all time points. Multivariate longitudinal analysis incorporating primary and secondary patient-rated outcomes showed that the SMT with HE group was superior to the HE-alone group in both the short- and long-term. No serious adverse events were observed as a result of the study treatments. CONCLUSIONS: SMT with HE resulted in greater pain reduction after 12 weeks of treatment compared with both supervised plus HE and HE alone. Supervised exercise sessions added little benefit to the HE-alone program.

Supervised exercise with and without spinal manipulation performs similarly and better than home exercise for chronic neck pain: a randomized controlled trial.

STUDY DESIGN: Randomized controlled trial using mixed methods. OBJECTIVE: To evaluate the relative effectiveness of high-dose supervised exercise with and without spinal manipulation and low-dose home exercise for chronic neck pain. SUMMARY OF BACKGROUND DATA: Neck pain is a common global health care complaint with considerable social and economic impact. Systematic reviews have found exercise therapy (ET) to be effective for neck pain, either alone or in combination with spinal manipulation. However, it is unclear to what extent spinal manipulation adds to supervised exercise or how supervised high-dose exercise compares with low-dose home exercise. METHODS: Two hundred and seventy patients with chronic neck pain were studied at an outpatient clinic. Patients were randomly assigned one of the following interventions: (1) high-dose supervised strengthening exercise with spinal manipulation (exercise therapy combined with spinal manipulation therapy [ET + SMT]), (2) high-dose supervised strengthening exercise (ET) alone, or (3) low-dose home exercise and advice (HEA). The primary outcome was patient-rated pain at baseline and at 4, 12, 26, and 52 weeks. Secondary measures were disability, health status, global perceived effect, medication use, and satisfaction. RESULTS: At 12 weeks, there was a significant difference in patient-rated pain between ET + SMT and HEA (1.3 points, P < 0.001) and ET and HEA (1.1 points, P = 0.001). Although there were smaller group differences in patient-rated pain at 52 weeks (ET + SMT vs. HEA, 0.2 points, P > 0.05; ET vs. HEA, 0.3 points, P > 0.05), linear mixed model analyses incorporating all time points yielded a significant advantage for the 2 supervised exercise groups (ET + SMT vs. HEA, P = 0.03; ET vs. HEA, P = 0.02). Similar results were observed for global perceived effect and satisfaction. CONCLUSION: Supervised strengthening exercise with and without spinal manipulation performed similarly, yielding better outcomes than home exercise particularly in the short term. Various stakeholders' perspectives should be considered carefully when making recommendations regarding these therapies, taking into account side effects, preferences, and costs.

Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial.

BACKGROUND CONTEXT: Several conservative therapies have been shown to be beneficial in the treatment of chronic low back pain (CLBP), including different forms of exercise and spinal manipulative therapy (SMT). The efficacy of less time-consuming and less costly self-care interventions, for example, home exercise, remains inconclusive in CLBP populations. PURPOSE: The purpose of this study was to assess the relative efficacy of supervised exercise, spinal manipulation, and home exercise for the treatment of CLBP. STUDY DESIGN/SETTING: An observer-blinded and mixed-method randomized clinical trial conducted in a university research clinic in Bloomington, MN, USA. PATIENT SAMPLE: Individuals, 18 to 65 years of age, who had a primary complaint of mechanical LBP of at least 6-week duration with or without radiating pain to the lower extremity were included in this trial. OUTCOME MEASURES: Patient-rated outcomes were pain, disability, general health status, medication use, global improvement, and satisfaction. Trunk muscle endurance and strength were assessed by blinded examiners, and qualitative interviews were performed at the end of the 12-week treatment phase. METHODS: This prospective randomized clinical trial examined the short- (12 weeks) and long-term (52 weeks) relative efficacy of high-dose, supervised low-tech trunk exercise, chiropractic SMT, and a short course of home exercise and self-care advice for the treatment of LBP of at least 6-week duration. The study was approved by local institutional review boards. RESULTS: A total of 301 individuals were included in this trial. For all three treatment groups, outcomes improved during the 12 weeks of treatment. Those who received supervised trunk exercise were most satisfied with care and experienced the greatest gains in trunk muscle endurance and strength, but they did not significantly differ from those receiving chiropractic spinal manipulation or home exercise in terms of pain and other patient-rated individual outcomes, in both the short- and long-term. CONCLUSIONS: For CLBP, supervised exercise was significantly better than chiropractic spinal manipulation and home exercise in terms of satisfaction with treatment and trunk muscle endurance and strength. Although the short- and long-term differences between groups in patient-rated pain, disability, improvement, general health status, and medication use consistently favored the supervised exercise group, the differences were relatively small and not statistically significant for these individual outcomes.

Long-term cardiovascular mortality among middle-aged men with gout.

BACKGROUND: There are limited data available on the association of gouty arthritis (gout) in middle age with long-term cardiovascular disease (CVD) mortality. METHODS: We performed a 17-year follow-up study of 9105 men, aged 41 to 63 years and at above-average risk for coronary heart disease, who were randomized to the Multiple Risk Factor Intervention Trial and who did not die or have clinical or electrocardiographic evidence of coronary artery disease during the 6-year trial. Risk of CVD death and other causes subsequent to the sixth annual examination associated with gout was assessed by means of Cox proportional hazards regressions. RESULTS: The unadjusted mortality rates from CVD among those with and without gout were 10.3 per 1000 person-years and 8.0 per 1000 person-years, respectively, representing an approximately 30% greater risk. After adjustment for traditional risk factors, use of diuretics and aspirin, and serum creatinine level, the hazard ratio (gout vs no gout) for coronary heart disease mortality was 1.35 (95% confidence interval [CI], 1.06-1.72). The hazard ratio for death from myocardial infarction was 1.35 (95% CI, 0.94-1.93); for death from CVD overall, 1.21 (95% CI, 0.99-1.49); and for death from any cause, 1.09 (95% CI, 1.00-1.19) (P = .04). The association between hyperuricemia and CVD was weak and did not persist when analysis was limited to men with hyperuricemia without a diagnosis of gout. CONCLUSION: Among middle-aged men, a diagnosis of gout accompanied by an elevated uric acid level imparts significant independent CVD mortality risk. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00000487.

Association of single measurements of dipstick proteinuria, estimated glomerular filtration rate, and hematocrit with 25-year incidence of end-stage renal disease in the multiple risk factor intervention trial.

The incidence of ESRD is increasing rapidly. Limited information exists regarding early markers for the development of ESRD. This study aimed to determine over 25 yr the risk for ESRD associated with proteinuria, estimated GFR (eGFR), and hematocrit in men who did not have identified kidney disease and were randomly assigned into the Multiple Risk Factor Intervention Study (MRFIT). A total of 12,866 men who were at high risk for heart disease were enrolled (1973 to 1975) and followed through 1999. Renal replacement therapy was ascertained by matching identifiers with the United States Renal Data System's data; vital status was from the National Death Index. Men who initiated renal replacement therapy or died as a result of kidney disease were deemed to have developed ESRD. Dipstick urine for proteinuria, eGFR, and hematocrit were related to development of ESRD. During 25 yr, 213 (1.7%) men developed ESRD. Predictors of ESRD were dipstick proteinuria of 1+ or > or =2+ (hazard ratio [HR] 3.1 [95% confidence interval (CI) 1.8 to 5.4] and 15.7 [95% CI 10.3 to 23.9] respectively) and an eGFR of <60 ml/min per 1.73 m(2) (HR 2.4; 95% CI 1.5 to 3.8). Correlation between eGFR and serum creatinine was 0.9; the risk for ESRD with a 1-SD difference of each was identical (HR 1.21). Bivariate analysis demonstrated a 41-fold increase in ESRD risk in those with an eGFR <60 ml/min per 1.73 m(2) and > or =2+ proteinuria (95% CI 15.2 to 71.1). There was no association between hematocrit and ESRD. Other baseline measures that independently predicted ESRD included age, cigarette smoking, BP, low HDL cholesterol, and fasting glucose. Among middle-aged men who were at high risk for cardiovascular disease but had no clinical evidence of cardiovascular disease or significant kidney disease, dipstick proteinuria and an eGFR value <60 ml/min per 1.73 m(2) were strong predictors of long-term development of ESRD. It remains unknown whether intervention for proteinuria or early identification of those with chronic kidney disease reduces the risk for ESRD.

Pulse pressure and cardiovascular disease-related mortality: follow-up study of the Multiple Risk Factor Intervention Trial (MRFIT).

CONTEXT: The sixth Joint National Committee (JNC-VI) classification system of blood pressure emphasizes both systolic blood pressure (SBP) and diastolic blood pressure (DBP) for cardiovascular disease risk assessment. Pulse pressure may also be a valuable risk assessment tool. OBJECTIVE: To compare relationships of SBP, DBP, and pulse pressure, separately and jointly, with cardiovascular disease-related mortality in men. DESIGN AND SETTING: Data from the Multiple Risk Factor Intervention Trial (MRFIT), which screened men aged 35 to 57 years from 1973 through 1975 at 22 US centers, was used to assess cardiovascular disease-related mortality through 1996. PARTICIPANTS: A total of 342 815 men without diabetes or a history of myocardial infarction were divided into 2 groups based on their age at MRFIT screening (35- to 44-year-olds and 45- to 57-year olds). Participant blood pressure levels were classified into a JNC-VI blood pressure category based on SBP and DBP (optimal, normal but not optimal, high normal, stage 1 hypertension, stage 2-3 hypertension), and pulse pressure was calculated. MAIN OUTCOME MEASURE: Cardiovascular disease-related mortality. RESULTS: There were 25 721 cardiovascular disease-related deaths. Levels of SBP and DBP were more strongly related to cardiovascular disease than pulse pressure. Relationships of SBP, DBP, and pulse pressure to cardiovascular disease-related mortality varied within JNC-VI category. Concordant elevations of SBP and DBP were associated with a greater risk of cardiovascular disease-related mortality for both age groups of men. Among men aged 45 to 57 years, higher SBP and lower DBP (discordant elevations) also yielded a greater risk of cardiovascular disease-related mortality. CONCLUSION: In both age groups, cardiovascular disease risk assessment was improved by considering both SBP and DBP, not just SBP, DBP, or pulse pressure separately.