Potential Cost Savings with 60-day Peripheral Nerve Stimulation Treatment in Chronic Axial Low Back Pain.

INTRODUCTION: Chronic axial low back pain (CLBP) that is not responsive to medication management or physical therapy often requires significant clinical intervention. Several interventional pain management options exist, including a 60-day peripheral nerve stimulation (PNS) treatment. This economic evaluation investigated the potential for projected cost savings associated with prioritizing 60-day PNS treatment relative to a 'standard of care' (SOC) approach (where patients do not have access to 60-day PNS). METHODS: A decision tree (supervised machine learning) model tracked treatment progression across two hypothetical cohorts of US patients with CLBP in whom non-interventional options were ineffective (Cohort A: treatment starting with 60-day PNS followed by any additional interventional and surgical treatments versus Cohort B: standard of care interventional and surgical treatments without access to 60-day PNS). Treatment efficacy estimates were based on published success rates. Conditional on treatment failure, up to two additional interventions were considered within the 12-month time frame in both cohorts. SOC treatment options included epidural injection, radiofrequency ablation (RFA), basivertebral nerve ablation (BVNA), PNS permanent implant (PNS-PI), spinal cord stimulator (SCS) trial/implant, and spinal fusion surgery. Treatment choice probabilities in both cohort algorithms were based on clinician interviews. Costs were based on national Medicare reimbursement levels in the ambulatory surgery center (ASC) setting. Savings reflected the difference in projected costs between cohorts. A Monte Carlo simulation and sensitivity analyses were conducted to generate confidence intervals and identify important inputs. RESULTS: The treatment algorithm which prioritized initial 60-day PNS treatment was projected to save $8056 (95% CI $6112-$9981) per patient during the first year of interventional treatment relative to the SOC approach. CONCLUSIONS: Use of the 60-day PNS treatment as an initial interventional treatment in patients with CLBP may result in significant savings for Medicare. Projected savings may be even larger for commercial payers covering non-Medicare patients.

Primary diffuse leptomeningeal gliomatosis.

BACKGROUND: Primary diffuse leptomeningeal gliomatosis (PDLG) is a rare presentation of a primary central nervous system glial tumor. METHODS: Four case reports of PDLG in young males aged 14-24 years are presented. These reports are discussed in the context of the existing literature. RESULTS: The clinical presentation of 4 new cases of PDLG resembled chronic meningitis with and without polyradiculopathy. Spinal fluid studies are typically nondiagnostic, but characteristically show elevated opening pressure, an elevated protein level, and a relative paucity of cellular reaction. An accurate antemortem diagnosis required contrast-enhanced imaging and meningeal biopsy in all 4 of our cases. Treatment strategies including craniospinal radiation and chemotherapeutic approaches, alone or in combination, have not been proven to alter the course of the disease. Initial responses to temozolomide and radiation treatments in all 4 of our cases were promising, resulting in temporary stabilization of the disease and prolonging life expectancy over what was previously reported in the literature. CONCLUSION: Total neuroaxis contrast-enhanced MRI scanning is required for directing biopsy confirmation and detecting the extent of the disease. More effective therapeutic strategies are needed, but the combination of temozolomide and radiation therapy may slow disease progression.

Blinding protocols, treatment credibility, and expectancy: methodologic issues in clinical trials of osteopathic manipulative treatment.

CONTEXT: In testing an experimental new drug or therapy, the gold standard in biomedical research for determining treatment efficacy is the randomized controlled trial (RCT). In pharmaceutical trials, inert placebos are an easily administered control that facilitates blinded comparisons. In clinical trials that study the effects of manual interventions, researchers must carefully consider their use of treatment control models. Choosing credible controls that will minimize bias in osteopathic manipulative treatment (OMT) clinical trials poses unique challenges to researchers because of heterogeneous OMT methods and practice. OBJECTIVE: To compare the treatment credibility of sham manipulative treatment and untreated controls to active OMT. METHODS: Subjects recruited for an OMT clinical trial for chronic low back pain completed a treatment-credibility rating scale comparing two written descriptions of the study interventions offered. The scale was administered to subjects before trial entry and at 6-month follow-up. Scale scores were used to compute credibility ratios for both intervention protocols (ie, OMT vs sham manipulative treatment). Repeated measures analysis of variance was used to assess changes in the credibility ratio over time, including the measurement of study group and time main effects, as well as study group x time interaction effects. RESULTS: Subjects (N=91) perceived OMT as a more credible therapeutic option than sham manipulative treatment both at trial entry and at 6-month follow-up (P<.05). Among subjects completing the study protocol (n=66), there were no changes in perceived credibility of the study interventions over time. There were no significant differences in the credibility ratio among study groups (P=.64) or over time (P=.79). In addition, there were no significant study group x time interactions (P=.59). CONCLUSIONS: In clinical trials, OMT may be perceived by subjects as a more credible treatment alternative than many control procedures. Treatment credibility can interact with subject expectations and study design in complex ways. When analyzing the treatment effects of OMT, investigators must consider the effects of these two subjective elements when competing interventions are offered and subjects are asked to self-report data. Study design should be optimized to equalize these effects among interventions.

Cost-effective osteopathic manipulative medicine: a literature review of cost-effectiveness analyses for osteopathic manipulative treatment.

Despite the value that osteopathic manipulative medicine (OMM) may offer to healthcare consumers in a managed care, evidence-based healthcare system, very little research has been published on the cost-effectiveness of osteopathic manipulative treatment compared with other treatment modalities. The authors searched MEDLINE and OSTMED for English-language articles published between January 1966 and June 2002 using the key terms cost-effectiveness, osteopathic medicine, workers' compensation, hospital length of stay, healthcare providers, and manipulative medicine. The authors then extended their search by reviewing the reference lists provided in the articles initially identified as relevant by these databases. The purpose, methods, findings, and conclusions of each study were evaluated for how the cost-effectiveness of OMM was analyzed. The authors conclude that the osteopathic medical profession needs to conduct and publish research that is consistent with current practices in the conventional medical literature.

Development of the Attitudes Toward Osteopathic Principles and Practice Scale (ATOPPS): preliminary results.

Little empirical work has been done to examine how osteopathic medical students' attitudes toward osteopathic principles and practice (OPP) develop and evolve over the course of their medical education. A major obstacle to conducting this research is the absence of reliable and sensitive instruments to measure students' attitudes toward OPP. The purpose of this project is to develop a sensitive and reliable instrument to measure students' attitudes toward OPP. Face-to-face and telephone interviews were conducted with osteopathic medical students, osteopathic manipulative medicine (OMM) residents, OMM undergraduate fellows, and three board-certified OMM specialists. These interviews were summarized in a 39-item instrument administered to 127 students at the completion of their core OMM rotation at the University of North Texas Health Science Center at Fort Worth-Texas College of Osteopathic Medicine. Factor analysis of student responses to the 39 candidate items yielded two interpretable factors. Factor 1 contained 24 items and accounted for 33% of the item response variance, and factor 2 contained four items and accounted for 5.6% of the item response variance. Based on these results, 14 of the original 39 statements were eliminated and the smaller second factor was dropped. Factor 1 contained items reflecting both positive and negative attitudes toward the application of OPP in patient care, the importance of OPP in medical education, and professional distinctiveness. One of the original 39 candidate items was returned to factor 1 because it was judged by the investigators to be consistent with the underlying construct of the scale and helped balance the number of forward-scored and reversed-scored items in the final instrument. Two internal consistency estimates of reliability were computed for the revised 25-item Attitudes Toward Osteopathic Principles and Practice Scale (ATOPPS): the Spearman-Brown unequal-length corrected coefficient alpha and the split-half reliability coefficients. Estimates for the split-half coefficients were .89 for part 1 and .87 for part 2. The Spearman-Brown coefficient alpha was .93, indicating substantial internal consistency. The 25-item ATOPPS seems to reflect a continuum of positive and negative attitudes toward OPP. This preliminary report documents reliability for the 25-item ATOPPS. With continued support for its construct validity, ATOPPS provides investigators with a reliable tool to assess the development of attitudes toward OPP.

Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial was conducted. OBJECTIVE: To determine the efficacy of osteopathic manipulative treatment as a complementary treatment for chronic nonspecific low back pain. SUMMARY OF BACKGROUND DATA: Osteopathic manipulative treatment may be useful for acute or subacute low back pain. However, its role in chronic low back pain is unclear. METHODS: This trial was conducted in a university-based clinic from 2000 through 2001. Of the 199 subjects who responded to recruitment procedures, 91 met the eligibility criteria. They were randomized, with 82 patients completing the 1-month follow-up evaluation, 71 completing the 3-month evaluation, and 66 completing the 6-month evaluation. The subjects were randomized to osteopathic manipulative treatment, sham manipulation, or a no-intervention control group, and they were allowed to continue their usual care for low back pain. The main outcomes included the SF-36 Health Survey, a 10-cm visual analog scale for overall back pain, the Roland-Morris Disability Questionnaire, lost work or school days because of back pain, and satisfaction with back care. RESULTS: As compared with the no-intervention control subjects, the patients who received osteopathic manipulative treatment reported greater improvements in back pain, greater satisfaction with back care throughout the trial, better physical functioning and mental health at 1 month, and fewer cotreatments at 6 months. The subjects who received sham manipulation also reported greater improvements in back pain and physical functioning and greater satisfaction than the no-intervention control subjects. There were no significant benefits with osteopathic manipulative treatment, as compared with sham manipulation. CONCLUSIONS: Osteopathic manipulative treatment and sham manipulation both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific low back pain. It remains unclear whether the benefits of osteopathic manipulative treatment can be attributed to the manipulative techniques themselves or whether they are related to other aspects of osteopathic manipulative treatment, such as range of motion activities or time spent interacting with patients, which may represent placebo effects.

Physicians' and patients' attitudes toward manual medicine: implications for continuing medical education.

INTRODUCTION: Manual medicine (MM) is a physical modality infrequently used in primary care clinics. This study examines primary care physicians' experience with and attitudes toward the use of MM in the primary care setting, as well as patients' experience with and attitudes toward MM. METHODS: Surveys were distributed to a convenience sample of physicians (54.3% response rate) attending a 1-week primary care continuing medical education (CME) conference in Kentucky. Similar surveys were also mailed to a random sample of primary care patients (35.3% response rate) living in a service region in which most conference attendees practiced. RESULTS: Similar responses were obtained from physicians and patients. A majority (81% and 76%, respectively) of physicians and patients felt that MM was safe, and over half (56% of physicians and 59% of patients) felt that MM should be available in the primary care setting. Although less than half (40%) of the physicians reported any educational exposure to MM and less than one-quarter (20%) have administered MM in their practice, most (71%) respondents endorsed desiring more instruction in MM. The majority of those seeking additional educational exposure (56%) were willing to pay for MM training that included CME credit. DISCUSSION: This survey suggests that primary care physicians feel that there is currently insufficient education in MM. The majority of physicians and patients feel that MM is beneficial, safe, and appropriate for use in a primary care setting. Thus, there may be a rising demand for quality instruction in MM from physical medicine doctors and other licensed therapists who currently practice MM.

Osteopathic manipulative treatment in conjunction with medication relieves pain associated with fibromyalgia syndrome: results of a randomized clinical pilot project.

Osteopathic physicians caring for patients with fibromyalgia syndrome (FM) often use osteopathic manipulative treatment (OMT) in conjunction with other forms of standard medical care. Despite a growing body of evidence on the efficacy of manual therapy for the treatment of selected acute musculoskeletal conditions, the role of OMT in treating patients with chronic conditions such as FM remains largely unknown. Twenty-four female patients meeting American College of Rheumatology criteria for FM were randomly assigned to one of four treatment groups: (1) manipulation group, (2) manipulation and teaching group, (3) moist heat group, and (4) control group, which received no additional treatment other than current medication. Participants' pain perceptions were assessed by use of pain thresholds measured at each of 10 bilateral tender points using a 9-kg dolorimeter, the Chronic Pain Experience Inventory, and the Present Pain Intensity Rating Scale. Patients' affective response to treatment was assessed using the Self-Evaluation Questionnaire. Activities of daily living were assessed using the Stanford Arthritis Center Disability and Discomfort Scales: Health Assessment Questionnaire. Depression was assessed using the Center for Epidemiological Studies Depression Scale. Significant findings between the four treatment groups on measures of pain threshold, perceived pain, attitude toward treatment, activities of daily living, and perceived functional ability were found. All of these findings favored use of OMT. This study found OMT combined with standard medical care was more efficacious in treating FM than standard care alone. These findings need to be replicated to determine if cost savings are incurred when treatments for FM incorporate nonpharmacologic approaches such as OMT.

Quality of life in referred patients presenting to a specialty clinic for osteopathic manipulative treatment.

Previous research has found that patients of osteopathic physicians tend to report poorer general health perceptions than persons in the general population or than patients of allopathic physicians. Quality of life and level of healthcare satisfaction in patients referred to a specialty clinic for osteopathic manipulative treatment (OMT) at a college of osteopathic medicine were measured in 1997. Data from the Medical Outcomes Study 36-Item Short Form (SF-36) were used to compute standardized scores in the following eight health scales: physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations because of emotional problems, and mental health. There were 185 patients who returned the survey (mean response rate, 90%), including 22 new and 163 established patients. Patients reported poorer health than the general population on all eight scales (P < .001). Patients frequently reported poorer quality of life than referents with hypertension, congestive heart failure, type 2 diabetes mellitus, recent acute myocardial infarction, or clinical depression. More than 97% of established patients were satisfied or very satisfied with the healthcare received at the clinic. This study suggests that referred patients presenting to osteopathic physicians for OMT may have poorer quality of life than is generally recognized when relying only on traditional diagnostic approaches. Early detection and treatment of musculoskeletal conditions may be important factors in preventing chronicity and its impact on quality of life.