Optimization of Spinal Manipulative Therapy Protocols: A Factorial Randomized Trial Within a Multiphase Optimization Framework

Spinal manipulative therapy (SMT) is a common nonpharmacological treatment for low back pain (LBP). Although generally supported by systematic reviews and practice guidelines, clinical trials evaluating SMT have been characterized by small effect sizes. This study adopts a Multiphase Optimization Strategy framework to examine individual components of an SMT delivery protocol using a single-blind trial with the goal of identifying and optimizing a multicomponent SMT protocol. We enrolled 241 participants with LBP. All participants received 2 SMT treatment sessions in the first week then were randomly assigned additional treatment based on a fully factorial design. The 3 randomized treatment components provided in twice weekly sessions over 3 weeks were multifidus activating exercise, spinal mobilizing exercise, and additional SMT dose. Primary outcomes included clinical (Oswestry Disability Index, numeric pain intensity rating) and mechanistic (spinal stiffness, multifidus muscle activation) measures assessed at baseline, 1, 4, and 12 weeks. Significant differences were found for the Oswestry index after 12 weeks for participants receiving multifidus activating exercise (mean difference = ?3.62, 97.5% CI: ?6.89, ?0.35; P= .01). There were no additional significant main or interaction effects for other treatment components or different outcome measures. The optimized SMT protocol identified in this study included SMT sessions followed by multifidus activating exercises.PerspectiveOptimizing the effects of nonpharmacological treatments such as SMT for LBP is challenging due to uncertainty regarding mechanisms and the complexity of multicomponent protocols. This factorial randomized trial examined SMT protocols provided with differing co-interventions with mechanistic and patient-centered outcomes. Patient-centered outcomes were optimized by inclusion of lumbar multifidus strengthening exercises.     

Magnetic Resonance Imaging Zygapophyseal Joint Space Changes (Gapping) in Low Back Pain Patients Following Spinal Manipulation and Side-Posture Positioning: A Randomized Controlled Mechanisms Trial With Blinding

ObjectiveThe purpose of this study was to quantify lumbar zygapophyseal (Z) joint space separation (gapping) in low back pain (LBP) subjects after spinal manipulative therapy (SMT) or side-posture positioning (SPP).MethodsThis was a controlled mechanisms trial with randomization and blinding. Acute LBP subjects (N = 112; four n = 28 magnetic resonance imaging [MRI] protocol groups) had 2 MRI appointments (initial enrollment and after 2 weeks of chiropractic treatment, receiving 2 MRI scans of the L4/L5 and L5/S1 Z joints at each MRI appointment. After the first MRI scan of each appointment, subjects were randomized (initial enrollment appointment) or assigned (after 2 weeks of chiropractic treatment appointment) into SPP (nonmanipulation), SMT (manipulation), or control MRI protocol groups. After SPP or SMT, a second MRI was taken. The central anterior-posterior joint space was measured. Difference between most painful side anterior-posterior measurements taken postintervention and preintervention was the Z joint “gapping difference.” Gapping differences were compared (analysis of variance) among protocol groups. Secondary measures of pain (visual analog scale, verbal numeric pain rating scale) and function (Bournemouth questionnaire) were assessed.ResultsGapping differences were significant at the first (adjusted, P = .009; SPP, 0.66 ± 0.48 mm; SMT, 0.23 ± 0.86; control, 0.18 ± 0.71) and second (adjusted, P = .0005; SPP, 0.65 ± 0.92 mm; SMT, 0.89 ± 0.71; control, 0.35 ± 0.32) MRI appointments. Verbal numeric pain rating scale differences were significant at first MRI appointment (P = .04) with SMT showing the greatest improvement. Visual analog scale and Bournemouth questionnaire improved after 2 weeks of care in all groups (both P < .0001).ConclusionsSide-posture positioning showed greatest gapping at baseline. After 2 weeks, SMT resulted in greatest gapping. Side-posture positioning appeared to have additive therapeutic benefit to SMT.     

Cost Analysis Related to Dose-Response of Spinal Manipulative Therapy for Chronic Low Back Pain: Outcomes From a Randomized Controlled Trial

Objective

The purpose of this analysis is to report the incremental costs and benefits of different doses of spinal manipulative therapy (SMT) in patients with chronic low back pain (LBP).

Methods

We randomized 400 patients with chronic LBP to receive a dose of 0, 6, 12, or 18 sessions of SMT. Participants were scheduled for 18 visits for 6 weeks and received SMT or light massage control from a doctor of chiropractic. Societal costs in the year after study enrollment were estimated using patient reports of health care use and lost productivity. The main health outcomes were the number of pain-free days and disability-free days. Multiple regression was performed on outcomes and log-transformed cost data.

Results

Lost productivity accounts for most societal costs of chronic LBP. Cost of treatment and lost productivity ranged from $3398 for 12 SMT sessions to $3815 for 0 SMT sessions with no statistically significant differences between groups. Baseline patient characteristics related to increase in costs were greater age (P = .03), greater disability (P = .01), lower quality-adjusted life year scores (P = .01), and higher costs in the period preceding enrollment (P < .01). Pain-free and disability-free days were greater for all SMT doses compared with control, but only SMT 12 yielded a statistically significant benefit of 22.9 pain-free days (P = .03) and19.8 disability-free days (P = .04). No statistically significant group differences in quality-adjusted life years were noted.

Conclusions

A dose of 12 SMT sessions yielded a modest benefit in pain-free and disability-free days. Care of chronic LBP with SMT did not increase the costs of treatment plus lost productivity.     

Spinal manipulative therapy for elderly patients with chronic obstructive pulmonary disease: a case series

Objective

The objective of this case series is to report the results of spinal manipulative therapy (SMT) for people with chronic obstructive pulmonary disease (COPD) who were older than 65 years.

Methods

The study design was a prospective case series. Six patients of a long-term care center who were older than 65 years and having COPD underwent a course of 12 SMT sessions over a 4-week period. Each SMT session consisted of manually applied spinal manipulation and instrument-assisted spinal manipulation delivered by a doctor of chiropractic. Lung function measurements were recorded at baseline and at 2 and 4 weeks. The occurrence and type of any adverse events (AEs) related to SMT were recorded at each SMT session.

Results

One male and 5 female patients took part in the study. The average age was 79.1 years (range, 68-89 years). There was a clinically significant increase in forced expiratory volume in the first second after SMT in 4 of the 6 patients at 2 weeks. This was sustained in only 1 patient at 4 weeks. No clinically significant changes were observed for forced vital capacity at 2 or 4 weeks. One hundred forty-four manually applied spinal manipulations and 72 instrument-assisted spinal manipulations were administered during the intervention period. No major or moderate AEs were reported. Only minor AEs were reported after 29% of the intervention sessions, with 1 AE being reported for each patient. All AEs resolved within 48 hours.

Conclusions

This case series offers preliminary evidence that SMT may have the potential to benefit lung function in patients with COPD who are older than 65 years.     

Spinal Manipulative Therapy–Specific Changes in Pain Sensitivity in Individuals With Low Back Pain (NCT01168999)

Spinal manipulative therapy (SMT) is effective for some individuals experiencing low back pain; however, the mechanisms are not established regarding the role of placebo. SMT is associated with changes in pain sensitivity, suggesting related altered central nervous system response or processing of afferent nociceptive input. Placebo is also associated with changes in pain sensitivity, and the efficacy of SMT for changes in pain sensitivity beyond placebo has not been adequately considered. We randomly assigned 110 participants with low back pain to receive SMT, placebo SMT, placebo SMT with the instructional set “The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people,” or no intervention. Participants receiving the SMT and placebo SMT received their assigned intervention 6 times over 2 weeks. Pain sensitivity was assessed prior to and immediately following the assigned intervention during the first session. Clinical outcomes were assessed at baseline and following 2 weeks of participation in the study. Immediate attenuation of suprathreshold heat response was greatest following SMT (P = .05, partial η² = .07). Group-dependent differences were not observed for changes in pain intensity and disability at 2 weeks. Participant satisfaction was greatest following the enhanced placebo SMT. This study was registered at www.clinicaltrials.gov under the identifier NCT01168999.PerspectiveThe results of this study indicate attenuation of pain sensitivity is greater in response to SMT than the expectation of receiving an SMT. These findings suggest a potential mechanism of SMT related to lessening of central sensitization and may indicate a preclinical effect beyond the expectations of receiving SMT.     

A randomized clinical trial of adjuvant chemotherapy after resection in patients with stomach cancer

A study group including 55 institutions in Japan evaluated the effect of adjuvant cyclophosphamide therapy on 461 patients who had undergone curative resection for stomach cancer. Patients, who were followed up for over three years, were randomly divided into three groups: curative resection and long-term drug therapy; curative resection and short-term drug therapy; and curative resection and no drug therapy. Long-term therapy consisted of (a) twice-weekly intravenous doses of 500 mg of cyclophosphamide for four weeks and, after five weeks with no medication, (b) 100 mg/day, given orally, for 40 days and, after ten weeks with no medication, (c) 100 mg/day, given orally, for 40 days. Short-term therapy consisted of only the first course of therapy (ie, twice-weekly intravenous doses of 500 mg for four weeks). The effect of cyclophosphamide differed, depending on the patients' levels of serosal and lymph node invasion: Short-term therapy was more effective in patients with lymph node involvement, and long-term therapy was more effective in patients with serosal involvement.     

Protease inhibitor-sparing simplified maintenance therapy: a need for perspective

Body fat changes and metabolic abnormalities such as hyperlipidaemia and diabetes have been increasingly reported following the successful introduction of highly active antiretroviral therapy (HAART). These side effects were attributed initially to the use of protease inhibitors (PIs). As a consequence, a series of trials were conducted where patients with well-controlled HIV viraemia either continued on PIs or were switched to a simplified maintenance therapy (SMT) without PIs. Evidence from these trials is still insufficient to show that switching from PIs to either abacavir, nevirapine or efavirenz is safe. However, patients with suboptimal pre-HAART treatment are at increased risk of virological failure if switched to an SMT. Patients switched from PI regimens tend to stay longer on an SMT and those switched to abacavir show a reduction in total cholesterol, but there is no evidence of any additional benefit from non-PI-based SMT. There is a clear need for a better understanding of HAART-related lipodystrophy and metabolic toxicity, and pharmacogenetic tests to identify those patients most at risk. The advent of simpler formulations for all drug classes, and new PIs with less metabolic toxicity, is likely to reshape completely the role of SMT.     

Critical care nurses' beliefs about and reported management of anxiety.

BACKGROUND: Anxiety is associated with increased morbidity and mortality. Critical care nurses are uniquely positioned to reduce anxiety in their patients. Critical care nurses' beliefs about and frequency of use of strategies to reduce anxiety have not been studied. OBJECTIVES: To explore critical care nurses' beliefs about the importance of anxiety management and to describe nurses' reported use of strategies to manage anxiety in their patients. METHODS: A random sample (N = 2500) of members of the American Association of Critical-Care Nurses was asked to complete the Critical Care Nurse Anxiety Identification and Management Survey. RESULTS: Respondents (n = 783) were primarily female (92%), white (88.5%) staff nurses (74.1%) who thought that anxiety is potentially harmful (mean, 4.1; SD, 0.8; range, 1 = no harm to 5 = life-threatening harm), that anxiety management is important (mean, 4.8; SD, 0.6; range, 1 = not important to 5 = very important), and that effective anxiety management is beneficial (mean, 4.6; SD, 0.6; range, 1 = no benefit to 5 = profound benefit). A majority commonly used pharmacological management; most also used information and communication interventions. Fewer subjects used the presence of patients' family members to alleviate patients' anxiety; few reported using stress-reduction techniques. CONCLUSION: Most respondents thought that treating anxiety is important and beneficial. Commonly used strategies included pharmacological relief of anxiety and pain and information and communication interventions. Although these strategies are useful, they may not effectively reduce anxiety in all patients.     

Noninvasive ventilation to prevent respiratory failure after extubation in high-risk patients

OBJECTIVE: Compared with standard medical therapy (SMT), noninvasive ventilation (NIV) does not reduce the need for reintubation in unselected patients who develop respiratory failure after extubation. The goal of this study was to assess whether early application of NIV, immediately after extubation, is effective in preventing postextubation respiratory failure in an at-risk population. DESIGN: Multiple-center, randomized controlled study. SETTING: Multiple hospitals. PATIENTS: Ninety-seven consecutive patients with similar baseline characteristics, requiring >48 hrs of mechanical ventilation and considered at risk of developing postextubation respiratory failure (i.e., patients who had hypercapnia, congestive heart failure, ineffective cough and excessive tracheobronchial secretions, more than one failure of a weaning trial, more than one comorbid condition, and upper airway obstruction). INTERVENTIONS: After a successful weaning trial, the patients were randomized to receive NIV for > or = 8 hrs a day in the first 48 hrs or SMT. Primary outcome was the need for reintubation according to standardized criteria. Secondary outcomes were intensive care unit and hospital mortality, as well as time spent in the intensive care unit and in hospital. MEASUREMENTS AND MAIN RESULTS: Compared with the SMT group, the NIV group had a lower rate of reintubation (four of 48 vs. 12 of 49; p = .027). The need for reintubation was associated with a higher risk of mortality (p < .01). The use of NIV resulted in a reduction of risk of intensive care unit mortality (-10%, p < .01), mediated by the reduction for the need of reintubation. CONCLUSIONS: NIV was more effective than SMT in preventing postextubation respiratory failure in a population considered at risk of developing this complication.     

Effect of additional functional exercises on balance in elderly people

OBJECTIVE: To evaluate the additional effect of functional exercises on balance and lower extremity function among hostel-dwelling elderly people partaking in strength,training. DESIGN: A randomized two-group parallel controlled trial. SETTING: A senior resident's hostel in Switzerland. PARTICIPANTS: Thirty-two individuals randomized to either strength or strength and functional exercise groups. INTERVENTIONS: Both groups received machine-driven strength training for 45 min, twice weekly, for 12 weeks. The strength and functional exercises group received an additional 30 min of functional exercise training, once weekly. MAIN OUTCOME MEASURES: Tinetti test, balance tests and a physical performance test. Assessments were performed before and after the intervention. RESULTS: Improvements for the balance test depended on the type of training (significant interaction effects [F(1,20)= 6.7; P = 0.018]). This test improved from 11.3 +/- 11.7 to 17 +/- 11.2 (P = 0.009) in the combined training group (n = 12) and remained from 7.3 +/- 9.5 to 6.9 +/- 9.2 unchanged (P = 0.821) in the strength training group (n = 13). A significant difference between groups following training was observed (P = 0.031). The Tinetti balance score and the chair stand test of the physical performance assessment improved from 14.3 +/- 1.9 to 15.3 +/- 1.1 (P = 0.026) and 1.8 +/- 1.2 to 2.8 +/- 1.1 (P = 0.012) respectively in the combined training group only. CONCLUSIONS: Our findings suggest that twice-weekly lower extremity strength training of 12 weeks' duration in hostel-dwelling elderly people only improves task-specific balance performance and lower extremity physical function when additional functional exercises are added.     

Short-term resistance training and the older adult: the effect of varied programmes for the enhancement of muscle strength and functional performance

Although it is well recognized that resistance training is an efficient strategy to enhance physical performance in older adults, less is known about the most effective type of resistive exercise or the role of functional training. This study compared the effectiveness of three varied short-term (8 weeks) training protocols on muscle strength and functional performance in older men and women aged 65-84 years. Participants underwent twice-weekly high-velocity varied-resistance training (HV), twice weekly slow to moderate-velocity constant-resistance training (CT), combined once weekly high-velocity varied-resistance and once weekly gymnasium-based functional training (CB) or no training (CO). Dynamic muscle strength (1RM) of six muscle groups was assessed using isotonic equipment and functional performance by a battery of tests. Following 8 weeks of training, whole-body muscle strength increased (P<0.001) by 22.0 +/- 12.5% (mean +/- SD), 21.7 +/- 11.0% and 26.1 +/-14.4% in HV, CT and CB, respectively, compared to CO (-1.8 +/- 7.2%). In between group comparisons, only the HV group displayed greater chair rise ability (P =0.010) than the CO group, while differences among groups approached significance for the fast 6-m walk and the stair climb test (P = 0.017 and 0.041 respectively). Within groups, the HV group significantly improved in stair-climbing and chair rise ability (P相似文献   

Suboccipital injection with a mixture of rapid- and long-acting steroids in cluster headache: a double-blind placebo-controlled study

Oral steroids can interrupt bouts of cluster headache (CH) attacks, but recurrence is frequent and may lead to steroid-dependency. Suboccipital steroid injection may be an effective 'single shot' alternative, but no placebo-controlled trial is available. The aim of our study was to assess in a double-blind placebo-controlled trial the preventative effect on CH attacks of an ipsilateral steroid injection in the region of the greater occipital nerve. Sixteen episodic (ECH) and seven chronic (CCH) CH outpatients were included. ECH patients were in a new bout since no more than 1 week. After a one-week run-in period, patients were allocated by randomization to the placebo or verum arms and received on the side of attacks a suboccipital injection of a mixture of long- and rapid-acting betamethasone (n=13; Verum-group) or physiological saline (n=10; Plac-group). Acute treatment was allowed at any time, additional preventative therapy if attacks persisted after 1 week. Three investigators performed the injections, while four others, blinded to group allocation, followed the patients. Follow-up visits were after 1 and 4 weeks, whereafter patients were followed routinely. Eleven Verum-group patients (3 CCH) (85%) became attack-free in the first week after the injection compared to none in the Plac-group (P=0.0001). Among them eight remained attack-free for 4 weeks (P=0.0026). Remission lasted between 4 and 26 months in five patients. A single suboccipital steroid injection completely suppresses attacks in more than 80% of CH patients. This effect is maintained for at least 4 weeks in the majority of them.     

Long-term plasma exchange as maintenance therapy for cerebellar-type Hashimoto’s encephalopathy,a case report

Hashimoto’s encephalopathy (HE) is a presumed autoimmune disorder associated with anti-thyroid autoantibodies and signs and symptoms of encephalopathy. A sub-type of HE is associated with cerebellar dysfunction and ataxia. Immunosuppressive therapy, particularly corticosteroid treatment, is utilized in the majority of cases. Short-term apheresis has been reported with variable patient responses. Here we report the case of a 72?year-old female with an ～15?year history of cerebellar type HE that had profound improvement in symptoms after long-term apheresis treatment over an ～2?year period. Following an induction phase, twice-weekly maintenance apheresis of 1 plasma volume reversed long-standing severe gait ataxia that had required a walker, as well as mild cognitive symptoms. This paralleled reductions in anti-thyroid antibody levels. Holidays from apheresis lasting several weeks and/or reductions in maintenance apheresis frequency to once per-week resulted in re-expression of ataxia and cognitive impairments along with a rise in anti-thyroid antibody levels. An apheresis dose-effect was observed whereby parallel rise and fall in both symptomatology and antibody levels would mirror duration between apheresis intervals. To our knowledge, this is the first report of profound therapeutic benefit and a dose-response relationship to long-term apheresis in cerebellar-type HE. This case suggests that maintenance apheresis be considered in responsive patients, particularly in those with contraindications to medical immunosuppression.     

An Exploratory Analysis of Gender as a Potential Modifier of Treatment Effect Among Patients in a Randomized Controlled Trial of Integrative Acupuncture and Spinal Manipulation for Low Back Pain

ObjectiveTo identify the potential association of self-reported gender on pain and disability among patients in a randomized controlled trial of integrative acupuncture and spinal manipulation therapy (SMT) for low back pain (LBP).MethodsIn the original study, 100 participants with LBP were randomized to receive acupuncture, SMT, or both combined. Eighty completed treatment and were followed for 60 days. Primary outcome measures were the Roland-Morris Disability Questionnaire and numeric pain scales. This study was a secondary analysis and used regression models to estimate and test for gender-specific differences in outcomes from baseline through end of treatment.ResultsWomen assigned to acupuncture averaged a 3.8-point reduction in highest LBP vs 2.0 points for SMT, whereas men assigned to SMT averaged a 3.5-point reduction vs 1.8 points for acupuncture (P for interaction = .04). There was a trend toward the same for disability (P for interaction = .12). For women, acupuncture alone led to better outcomes without SMT, and for men, SMT alone led to better outcomes without acupuncture. Women who received acupuncture were more likely to experience 50% or greater reductions in disability and pain, whereas men who received SMT were more likely to experience 50% or greater reductions in disability and pain.ConclusionAn association was found between self-reported gender and response to LBP treatment. Women demonstrated a greater reduction in pain and disability with acupuncture and men with SMT. Future clinical trials should consider sex as a potential determinant of treatment outcomes for LBP.     

Evaluating the relationship among cavitation, zygapophyseal joint gapping, and spinal manipulation: an exploratory case series

Objective

This project determined the feasibility of conducting larger studies assessing the relationship between cavitation and zygapophyseal (Z) joint gapping following spinal manipulative therapy (SMT).

Methods

Five healthy volunteers (average age, 25.4 years) were screened and examined against inclusion and exclusion criteria. High-signal magnetic resonance imaging (MRI) markers were fixed to T12, L3, and S1 spinous processes. Scout images were taken to verify the location of the markers. Axial images of the L4/L5 and L5/S1 levels were obtained in the neutral supine position. Following the first MRI, accelerometers were placed over the same spinous processes; and recordings were made from them during side-posture positioning and SMT. The accelerometers were removed, and each subject was scanned in side-posture. The greatest central anterior to posterior Z joint spaces (gap) were measured from the first and second MRI scans. Values obtained from the first scan were subtracted from those of the second, with a positive result indicating an increase in gapping following SMT (positive gapping difference). Gapping difference was compared between the up-side (SMT) joints vs the down-side (non-SMT) joints and between up-side cavitation vs up-side noncavitation joints.

Results

Greater gapping was found in Z joints that received SMT (0.5 ± 0.6 mm) vs non-SMT joints (−0.2 ± 0.6 mm), and vertebral segments that cavitated gapped more than those that did not cavitate (0.8 ± 0.7 vs 0.4 ± 0.5 mm).

Conclusions

A future clinical study is quite feasible. Forty subjects (30 in an SMT group and 10 in a control group) would be needed for appropriate power (0.90).     

Spinal manipulative therapy versus a low force mimic maneuver for women with primary dysmenorrhea: a randomized, observer-blinded, clinical trial.

Non-drug therapies for women with primary dysmenorrhea are primarily based on anecdotal evidence and small-scale clinical studies. This randomized, observer-blinded, clinical trial evaluated the efficacy of spinal manipulative therapy (SMT) in the treatment of women with primary dysmenorrhea. Women were recruited from the Chicago metropolitan area and evaluated for inclusion through four screening levels. One hundred thirty eight women, ages 18-45, with primary dysmenorrhea diagnosed by participating gynecologists, were randomly assigned to either SMT or a low-force mimic (LFM) maneuver. No treatment occurred at menstrual cycle 1. Treatment for both groups took place on day 1 of cycles 2, 3 and 4, and prophylactic treatment of three visits took place during the 7 days before cycles 3 and 4. Main outcome measures were the Visual Analog Scale (VAS) and plasma concentration of the prostaglandin F2alpha metabolite, 15-keto-13,14-dihydro-prostaglandin F2alpha (KDPGF2alpha), measured 15 min before treatment and 60 min after treatment on day 1 of four consecutive menstrual cycles. The Moos' Menstrual Distress Questionnaire (MDQ) was also administered after treatment on day 1 of each cycle. At cycle 2, the post-treatment VAS scores decreased for both groups, with no statistically significant difference in pre- to post-treatment scores between the two groups (P = 0.44). The changes in pre- to post-treatment KDPGF2alpha levels were not statistically different between the SMT and LFM groups (P = 0.15). No treatment effects were detected over the three cycles for VAS, KDPGF2alpha or MDQ (P = 0.65, P = 0.61 and P = 0.78, respectively). However, there were statistically significant linear time effects for VAS (P = 0.008), MDQ (P < 0.001), and borderline significance for KDPGF2alpha (P = 0.054); these decreases were not considered clinically meaningful. The LFM maneuver used in this study was designed to act as a 'placebo-like' control treatment in comparison with SMT. Although it is possible that the trial did not continue long enough for any placebo effect of the LFM to wash out, it seems more likely that this maneuver was indistinguishable from SMT. Therefore, the postulated superior benefit of high-velocity, short-lever, low-amplitude, high-force spinal manipulation to a low-force maneuver is not supported by the results of this study. 1999 International Association for the Study of Pain.     

Quality of life as a clinical trial endpoint: determining the appropriate interval for repeated assessments in patients with advanced lung cancer

One of the unresolved design issues for clinical trials with quality of life (QOL) as an endpoint is the frequency of measurement in patients with stage III and IV lung cancer. In a retrospective review of clinical trials, the QOL interval varied widely from 1 to 12 weeks during treatment. During follow-up, the interval was generally 2 to 3 months or not at all. The purpose of this methodological study was to determine an appropriate interval for QOL serial measurement based on prospectively collected data. The 20 patients for this study were part of a phase I/II study using combination chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). They were typical of patients in lung cancer clinical trials, with a median age of 67 (interquartile range: 58, 72) years, the majority were male (13, 65%), and a baseline median Karnofsky performance status was 80 (interquartile range: 70%, 90%). The primary instrument, developed in 1985, was the Lung Cancer Symptom Scale (LCSS) patient form, a 9-item self-report and site-specific QOL measure. The method, outcome, and implication of these findings to research are presented for establishing a method for obtaining an appropriate serial measurement interval for QOL during therapy in clinical trials. Based on the findings of this study, an every 3-week QOL assessment for patients with advanced NSCLC provides data similar to more frequent evaluation (94% of data preserved compared to twice-weekly assessment, 95% confidence interval, 86–98%, p=0.05). Less frequent assessment (every 4 or every 6 weeks) retained less than 85% of the data, which is the recommended minimum adequacy rate. Retaining a high percentage of QOL information may lessen the effect of measurement bias due to patient attrition and may give more validity to QOL studies.     

Do early quadriceps exercises affect the outcome of ACL reconstruction? A randomised controlled trial

A prospective, blinded, randomised controlled trial investigated the effectiveness of quadriceps exercises following anterior cruciate ligament reconstruction. A treatment group (Quadriceps exercise group) performed straight leg raises and isometric quadriceps contractions throughout the first two postoperative weeks, and a second group (No quadriceps exercise group) did not. A battery of outcome measures assessed subjects postoperatively at day one, two weeks, and one, three and six months. A total of 103 patients (Quadriceps exercise n = 48, No quadriceps exercise n = 55) commenced the study with 91 subjects available at final follow up (Quadriceps exercise n = 47, No quadriceps exercise n = 44). Performance of quadriceps exercises significantly improved a number of knee flexion and extension range of motion measurements (p = 0.01 to 0.04). No significant differences were found between the two groups at any postoperative period for quadriceps lag (p = 0.36), functional hop testing (p = 0.49 to 0.51), isokinetic quadriceps strength (p = 0.70 to 0.72), the majority of numerical analogue scores (p = 0.1 to 0.94) and Cincinnati scores (p = 0.10 to 0.84). Subjects performing quadriceps exercises reported significantly higher pain scores with exercise on the first postoperative day (p = 0.02). At six months postoperatively, the Quadriceps exercise subjects reported significantly more favourable Cincinnati scores for symptoms (p = 0.005) and problems with sport (p = 0.05). While average knee laxity was not significantly different between treatment groups over time (p = 0.27 to 0.94), quadriceps exercise performance was associated with a significantly lower incidence of abnormal knee laxity. Isometric quadriceps exercises and straight leg raises can be safely prescribed during the first two postoperative weeks and confer advantages for faster recovery of knee range of motion and stability. It remains to be proven whether the magnitude of differences between groups is clinically significant.     

Comparing hyperlipidemia control with daily versus twice-weekly simvastatin

BACKGROUND: Costs associated with the use of hydroxymethylglutaryl coenzyme A reductase inhibitors are increasing. Finding ways to manage hyperlipidemia at lower costs is critical to all healthcare systems. OBJECTIVE: To assess effectiveness, safety, cost, and patients' satisfaction when converting hyperlipemic patients taking simvastatin daily to simvastatin twice weekly. METHODS: This nonrandomized, open-label, proof-of-concept study converted patients treated with simvastatin 10 or 20 mg daily to 40 or 80 mg twice weekly, respectively, for 12 weeks. The lipid profiles at enrollment, week 6, and week 12 were compared using repeated-measures ANOVA. The percentage of patients attaining the appropriate low-density lipoprotein cholesterol (LDL-C) goal was determined. RESULTS: Thirty-one patients completed the study. The proportion of patients at the LDL-C goal was not statistically different between enrollment and week 12 (87% vs 68%; p = 0.068). The mean LDL-C value +/- SD at weeks 6 and 12 increased compared with enrollment (112 +/-20, 111 +/-17, and 97 +/- 17 mg/dL, respectively; p < 0.001). Three (10%) patients reported nonadherence to the twice-weekly regimen. Seventeen (55%) patients reported that both regimens were equally convenient or preferred the twice-weekly regimen. Estimated cost-savings at our institution associated with this regimen would be $32 000 per 1000 patients per year. CONCLUSIONS: The twice-weekly regimen safely maintained most of the patients at their LDL-C goal level, and over half the patients found this regimen to be the same or easier to follow than a daily regimen. Large outcome studies evaluating this approach are needed.     

Learning Spinal Manipulation: Objective and Subjective Assessment of Performance

ObjectiveThe purpose of this study was to investigate associations between objective spinal manipulation therapy (SMT) biomechanical parameters and subjective assessments provided by patients, clinicians, and expert assessors.MethodsChiropractic students (N = 137) and expert instructors (N = 14) were recruited. Students were asked to perform a thoracic SMT alternately on each other on a force-sensing table while being observed by an expert instructor. Students who performed (clinicians) and received (patients) SMT, and expert instructors, independently scored each SMT performance using visual analog scales. Correlations between these subjective scores and SMT biomechanical parameters were calculated. The following parameters were evaluated: peak force, preload force, thrust duration, and drop in preload force. Spinal manipulation therapy comfort was also assessed by patients, clinicians, and expert instructors.ResultsResults of the study indicate that thrust duration assessed by instructors and patients was the only parameters significantly correlated with the table data (r = .37; P < .001 and r = .26; P = .002). Comfort assessed by clinicians was significantly correlated with their own assessments of thrust duration (r = .37; P < .001) and preload force (r = .23; P = .007), whereas comfort assessed by instructors was significantly correlated with their own assessment of thrust duration (r = .27; P = .002) and drop in preload force (r = -.34; P < .001). Objective biomechanical parameters of performance did not predict perceived comfort.ConclusionsOverall, the results from the subjective assessments of SMT performance are weakly correlated with objective measures of SMT performance. Only the thrust duration evaluated by expert instructors and patients was associated with scores obtained from the table. Perceived comfort of the procedure seems to be associated mostly with perceived thrust duration and preload characteristics.