Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial.

PURPOSE: We studied the efficacy of osteopathic manual treatment (OMT) and ultrasound therapy (UST) for chronic low back pain. METHODS: A randomized, double-blind, sham-controlled, 2 × 2 factorial design was used to study OMT and UST for short-term relief of nonspecific chronic low back pain. The 455 patients were randomized to OMT (n = 230) or sham OMT (n = 225) main effects groups, and to UST (n = 233) or sham UST (n = 222) main effects groups. Six treatment sessions were provided over 8 weeks. Intention-to-treat analysis was performed to measure moderate and substantial improvements in low back pain at week 12 (30% or greater and 50% or greater pain reductions from baseline, respectively). Five secondary outcomes, safety, and treatment adherence were also assessed. RESULTS: There was no statistical interaction between OMT and UST. Patients receiving OMT were more likely than patients receiving sham OMT to achieve moderate (response ratio [RR] = 1.38; 95% CI, 1.16-1.64; P <.001) and substantial (RR = 1.41, 95% CI, 1.13-1.76; P = .002) improvements in low back pain at week 12. These improvements met the Cochrane Back Review Group criterion for a medium effect size. Back-specific functioning, general health, work disability specific to low back pain, safety outcomes, and treatment adherence did not differ between patients receiving OMT and sham OMT. Nevertheless, patients in the OMT group were more likely to be very satisfied with their back care throughout the study (P <.001). Patients receiving OMT used prescription drugs for low back pain less frequently during the 12 weeks than did patients in the sham OMT group (use ratio = 0.66, 95% CI, 0.43-1.00; P = .048). Ultrasound therapy was not efficacious. CONCLUSIONS: The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients.

Analysis of provider specialties in the treatment of patients with clinically diagnosed back and joint problems.

RATIONALE, AIMS AND OBJECTIVES: Although several studies have compared patient outcomes by provider specialty in the treatment of back and joint pain, little is known about the cost-effectiveness of improving patient outcomes across specialties. This study uses a large-scale, nationally representative database to evaluate the cost-effectiveness of being treated by specific provider specialists for back and joint pain in the United States. METHOD: The 2002-2012 Medical Expenditure Panel Surveys were used to examine patients diagnosed with back and/or joint problems seeking treatment from doctors (internal medicine, family/general, osteopathic medicine, orthopaedics, rheumatology, neurology) or other providers (chiropractor, physical therapist, acupuncturist, massage therapist). A total of 16,546 respondents aged 18 to 85 and clinically diagnosed with back/joint pain were examined. Self-reported measures of physical and mental health and general quality of life (measured by the EuroQol-5D) were compared with average total costs of treatment across medical providers. RESULTS: Total annual treatment costs per person ranged from $397 for family/general doctors to $1205 for rheumatologists. Cost-effectiveness analysis suggests that osteopathic, family/general, internal medicine doctors and chiropractors and massage therapists were more cost-effective than other specialties in improving physical function to back pain patients. For mental health measures, family/general and orthopaedic doctors and physical therapists were more cost-effective compared with other specialties. Similar to results on physical function, family/general, osteopathic and internal medicine doctors dominated other specialties. However, only massage therapy was cost-effective among non-doctor providers in improving quality of life measures. CONCLUSIONS: Patients seeking care for back and joint-related health problems face a wide range of treatments, costs and outcomes depending on which specialist provider they see. This study provides important insight on the relationship between health care costs and patients' perceived physical and mental health status from receiving treatment for diagnosed back/joint problems.

Changes in biomechanical dysfunction and low back pain reduction with osteopathic manual treatment: results from the OSTEOPATHIC Trial.

The purpose of this study was to measure changes in biomechanical dysfunction following osteopathic manual treatment (OMT) and to assess how such changes predict subsequent low back pain (LBP) outcomes. Secondary analyses were performed with data collected during the OSTEOPATHIC Trial wherein a randomized, double-blind, sham-controlled, 2 × 2 factorial design was used to study OMT for chronic LBP. At baseline, prevalence rates of non-neutral lumbar dysfunction, pubic shear, innominate shear, restricted sacral nutation, and psoas syndrome were determined in 230 patients who received OMT. Five OMT sessions were provided at weeks 0, 1, 2, 4, and 6, and the prevalence of each biomechanical dysfunction was again measured at week 8 immediately before the final OMT session. Moderate pain improvement (≥30% reduction on a 100-mm visual analogue scale) at week 12 defined a successful LBP response to treatment. Prevalence rates at baseline were: non-neutral lumbar dysfunction, 124 (54%); pubic shear, 191 (83%); innominate shear, 69 (30%); restricted sacral nutation, 87 (38%), and psoas syndrome, 117 (51%). Significant improvements in each biomechanical dysfunction were observed with OMT; however, only psoas syndrome remission occurred more frequently in LBP responders than non-responders (P for interaction = 0.002). Remission of psoas syndrome was the only change in biomechanical dysfunction that predicted subsequent LBP response after controlling for the other biomechanical dysfunctions and potential confounders (odds ratio, 5.11; 95% confidence interval, 1.54-16.96). These findings suggest that remission of psoas syndrome may be an important and previously unrecognized mechanism explaining clinical improvement in patients with chronic LBP following OMT.

Somatic dysfunction and use of osteopathic manual treatment techniques during ambulatory medical care visits: a CONCORD-PBRN study.

CONTEXT: Osteopathic manual treatment (OMT) of somatic dysfunction is a unique approach to medical care that may be studied within a practice-based research network. OBJECTIVE: To measure patient characteristics and osteopathic physician practice patterns within the Consortium for Collaborative Osteopathic Research Development-Practice-Based Research Network (CONCORD-PBRN). DESIGN: Cross-sectional card study. SETTING: Eleven member clinics within the CONCORD-PBRN coordinated by The Osteopathic Research Center. PATIENTS: A total of 668 patients seen between January and March 2013. MAIN STUDY MEASURES: Patient age and sex; primary diagnoses; somatic dysfunction as manifested by tenderness, asymmetry, restricted motion, or tissue texture changes; and use of 14 OMT techniques. Results were stratified by anatomical region and adjusted for clustering within member clinics. Clustering was measured by the intracluster correlation coefficient. RESULTS: Patient ages ranged from 7 days to 87 years (adjusted mean age, 49.2 years; 95% confidence interval [CI], 43.3-55.1 years). There were 450 females (67.4%) and 508 patient visits (76.0%) involved a primary diagnosis of disease of the musculoskeletal system and connective tissue. Structural examination was performed during 657 patient visits (98.4%), and 649 visits (97.2%) involved OMT. Restricted motion and tenderness were the most and least common palpatory findings, respectively. Cranial (1070 [14.5%]), myofascial release (1009 [13.7%]), muscle energy (1001 [13.6%]), and counterstrain (980 [13.3%]) techniques were most commonly used, accounting for more than one-half of the OMT provided. Pediatric patients were more likely than adults to receive OMT within the head (adjusted odds ratio [OR], 9.53; 95% CI, 1.28-71.14). Geriatric patients were more likely than adults to receive a structural examination (adjusted OR, 1.83; 95% CI, 1.09-3.07) and OMT (adjusted OR, 1.62; 1.02-2.59) within the lower extremity. Females were more likely than males to receive a structural examination (adjusted OR, 2.44; 95% CI, 1.44-4.16) and OMT (adjusted OR, 2.11; 95% CI, 1.26-3.52) within the sacrum and OMT within the pelvis (adjusted OR, 1.79; 95% CI, 1.12-2.88). Intracluster correlation coefficients for the 4 most commonly used OMT techniques ranged from 0.34 to 0.72. CONCLUSION: This study provides proof of concept of the feasibility of studying osteopathic medical practice on a national level by developing and growing the CONCORD-PBRN.

Outcomes of osteopathic manual treatment for chronic low back pain according to baseline pain severity: results from the OSTEOPATHIC Trial.

PURPOSE: To assess response to osteopathic manual treatment (OMT) according to baseline severity of chronic low back pain (LBP). METHODS: The OSTEOPATHIC Trial used a randomized, double-blind, sham-controlled, 2×2 factorial design to study OMT for chronic LBP. A total of 269 (59%) patients reported low baseline pain severity (LBPS) (<50 mm/100 mm), whereas 186 (41%) patients reported high baseline pain severity (HBPS) (≥50 mm/100 mm). Six OMT sessions were provided over eight weeks and outcomes were assessed at week 12. The primary outcome was substantial LBP improvement (≥50% pain reduction). The Roland-Morris Disability Questionnaire (RMDQ) and eight other secondary outcomes were also studied. Response ratios (RRs) and 95% confidence intervals (CIs) were used in conjunction with Cochrane Back Review Group criteria to determine OMT effects. RESULTS: There was a large effect size for OMT in providing substantial LBP improvement in patients with HBPS (RR, 2.04; 95% CI, 1.36-3.05; P<0.001). This was accompanied by clinically important improvement in back-specific functioning on the RMDQ (RR, 1.80; 95% CI, 1.08-3.01; P=0.02). Both RRs were significantly greater than those observed in patients with LBPS. Osteopathic manual treatment was consistently associated with benefits in all other secondary outcomes in patients with HBPS, although the statistical significance and clinical relevance of results varied. CONCLUSIONS: The large effect size for OMT in providing substantial pain reduction in patients with chronic LBP of high severity was associated with clinically important improvement in back-specific functioning. Thus, OMT may be an attractive option in such patients before proceeding to more invasive and costly treatments.

Osteopathic manual treatment in patients with diabetes mellitus and comorbid chronic low back pain: subgroup results from the OSTEOPATHIC Trial.

CONTEXT: Chronic pain is often present in patients with diabetes mellitus. OBJECTIVE: To assess the effects of osteopathic manual treatment (OMT) in patients with diabetes mellitus and comorbid chronic low back pain (LBP). DESIGN: Randomized, double-blind, sham-controlled, 2×2 factorial trial, including OMT and ultrasound therapy (UST) interventions. SETTING: University-based study in Dallas-Fort Worth, Texas. PATIENTS: A subgroup of 34 patients (7%) with diabetes mellitus within 455 adult patients with nonspecific chronic LBP enrolled in the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial. MAIN STUDY MEASURES: The Outpatient Osteopathic SOAP Note Form was used to measure somatic dysfunction at baseline. A 100-mm visual analog scale was used to measure LBP severity over 12 weeks from randomization to study exit. Paired serum concentrations of tumor-necrosis factor (TNF)-α obtained at baseline and study exit were available for 6 subgroup patients. RESULTS: Key osteopathic lesions were observed in 27 patients (79%) with diabetes mellitus vs 243 patients (58%) without diabetes mellitus (P=.01). The reduction in LBP severity over 12 weeks was significantly greater in 19 patients with diabetes mellitus who received OMT than in 15 patients with diabetes mellitus who received sham OMT (mean between-group difference in changes in the visual analog scale pain score, -17 mm; 95% confidence interval [CI], -32 mm to -1 mm; P=.04). This difference was clinically relevant (Cohen d=0.7). A corresponding significantly greater reduction in TNF-α serum concentration was noted in patients with diabetes mellitus who received OMT, compared with those who received sham OMT (mean between-group difference, -6.6 pg/mL; 95% CI, -12.4 to -0.8 pg/mL; P=.03). This reduction was also clinically relevant (Cohen d=2.7). No significant changes in LBP severity or TNF-α serum concentration were associated with UST during the 12-week period. CONCLUSION: Severe somatic dysfunction was present significantly more often in patients with diabetes mellitus than in patients without diabetes mellitus. Patients with diabetes mellitus who received OMT had significant reductions in LBP severity during the 12-week period. Decreased circulating levels of TNF-α may represent a possible mechanism for OMT effects in patients with diabetes mellitus. A larger clinical trial of patients with diabetes mellitus and comorbid chronic LBP is warranted to more definitively assess the efficacy and mechanisms of action of OMT in this population.

Somatic dysfunction and its association with chronic low back pain, back-specific functioning, and general health: results from the OSTEOPATHIC Trial.

CONTEXT: Somatic dysfunction is diagnosed by the presence of any of 4 TART criteria: tissue texture abnormality, asymmetry, restriction of motion, or tenderness. OBJECTIVE: To measure the prevalence of somatic dysfunction in patients with chronic low back pain (LBP) and to study the associations of somatic dysfunction with LBP severity, back-specific functioning, and general health. DESIGN: Cross-sectional study nested within a randomized controlled trial. SETTING: University-based study in Dallas-Fort Worth, Texas. PATIENTS: A total of 455 adult research patients with non-specific chronic LBP. MAIN STUDY MEASURES: Somatic dysfunction in the lumbar, sacrum/pelvis, and pelvis/innominate regions, including key lesions representing severe somatic dysfunction. A 10-cm visual analog scale (VAS), the Roland-Morris Disability Questionnaire (RMDQ), and the Medical Outcomes Study Short Form-36 Health Survey (SF-36) were used to measure LBP severity, back-specific functioning, and general health, respectively. RESULTS: Severe somatic dysfunction was most prevalent in the lumbar (225 [49%]), sacrum/pelvis (129 [28%]), and pelvis/innominate (48 [11%]) regions. Only 30 patients (7%) had no somatic dysfunction in the lumbar, sacrum/pelvis, or pelvis/innominate regions. There were 4 statistically significant pairwise correlations for severe somatic dysfunction: thoracic (T) 10-12 with ribs; T10-12 with lumbar; lumbar with sacrum/pelvis; and sacrum/pelvis with pelvis/innominate. Having a key lesion in the lumbar region (ρ=0.80) or sacrum/pelvis region (ρ=0.71) was strongly correlated with the overall number of key lesions. There were no consistent demographic or clinical predictors of somatic dysfunction. The presence (vs absence) of severe somatic dysfunction in the lumbar region was associated with greater LBP severity (median VAS score, 4.7 vs 3.8, respectively; P=.003) and greater back-specific disability (median RMDQ score, 6 vs 4, respectively; P=.01). The presence (vs absence) of severe somatic dysfunction in the sacrum/pelvis region was associated with greater back-specific disability (median RMDQ score, 6 vs 5, respectively; P=.02) and poorer general health (median SF-36 score, 62 vs 72, respectively; P=.002). An increasing number of key lesions was associated with back-specific disability (P=.009) and poorer general health (P=.02). CONCLUSION: The present study demonstrates that somatic dysfunction, particularly in the lumbar and sacrum/pelvis regions, is common in patients with chronic LBP. Forthcoming extensions of the OSTEOPATHIC Trial will assess the efficacy of OMT according to baseline levels of somatic dysfunction.

A new triadic paradigm for osteopathic research in real-world settings.

Clinical research is increasingly conducted in real-world settings. Osteopathic practices represent natural laboratories for studying the distinctiveness of osteopathic medicine. The Osteopathic Research Center (ORC) recently developed a triadic paradigm for research consisting of the Consortium for Collaborative Osteopathic Research Development (CONCORD), its affiliated practice-based research network (PBRN), and the patient-centered research (PCR) fellowship program. The CONCORD-PBRN was certified by the Agency for Healthcare Research and Quality in 2011. The inaugural PCR fellowship class completed didactic training that year. Fellows increased their knowledge of research design and biostatistics following participation in the curriculum. In 2012, a card study of osteopathic palpatory findings and manual techniques will be conducted within the CONCORD-PBRN. The ORC plans to use a hub-and-spoke model to grow the CONCORD-PBRN. Further expansion of this triadic paradigm is dependent on funding streams to support the needed research infrastructure.

Associations of cytokine concentrations with key osteopathic lesions and clinical outcomes in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial.

CONTEXT: Little is known about the role that cytokines play in osteopathic manual treatment (OMT) of patients with chronic low back pain (LBP). OBJECTIVE: To measure the baseline concentrations of interleukin (IL)-1ß, IL-6, IL-8, IL-10, and tumor necrosis factor (TNF)-α in patients with chronic LBP; the correlations of these cytokine concentrations with clinical measures, including the number of key osteopathic lesions; the changes in cytokine concentrations with OMT; and the association of such changes with clinical outcomes. DESIGN: Substudy nested within a randomized controlled trial of OMT for nonspecific chronic LBP. SETTING: University-based study in Dallas-Fort Worth, Texas. PATIENTS: Seventy adult research patients with nonspecific chronic LBP. MAIN OUTCOME MEASURES: A 10-cm visual analog scale, the Roland-Morris Disability Questionnaire, and the Medical Outcomes Study Short Form-36 Health Survey were used to measure LBP severity, back-specific functioning, and general health, respectively. RESULTS: At baseline, IL-1ß (ρ = 0.33; P = .005) and IL-6 (ρ = 0.32; P = .006) were each correlated with the number of key osteopathic lesions; however, only IL-6 was correlated with LBP severity (ρ = 0.28; P = .02). There was a significantly greater reduction of TNF-α concentration after 12 weeks in patients who received OMT compared with patients who received sham OMT (Mann-Whitney U = 251.5; P = .03). Significant associations were found between OMT and a reduced TNF-α concentration response at week 12 among patients who achieved moderate (response ratio, 2.13; 95% confidence interval [CI], 1.11-4.06; P = .006) and substantial (response ratio, 2.13; 95% CI, 1.07-4.25; P = .01) LBP improvements, and improvement in back-specific functioning (response ratio, 1.68; 95% CI, 1.04-2.71; P = .03). CONCLUSIONS: This study found associations between IL-1ß and IL-6 concentrations and the number of key osteopathic lesions and between IL-6 and LBP severity at baseline. However, only TNF-α concentration changed significantly after 12 weeks in response to OMT. These discordant findings indicate that additional research is needed to elucidate the underlying mechanisms of action of OMT in patients with nonspecific chronic LBP.

Depression, somatization, and somatic dysfunction in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial.

CONTEXT: Depression and somatization are often present in patients with chronic low back pain (LBP). OBJECTIVES: To measure the presence of depression and somatization in patients with chronic LBP and to study the associations of depression and somatization with somatic dysfunction, LBP severity, back-specific functioning, and general health. DESIGN: Cross-sectional study using baseline measures collected within a randomized controlled trial. SETTING: University-based study in Dallas-Fort Worth, Texas. PATIENTS: A total of 202 adult research participants with nonspecific chronic LBP. MAIN STUDY MEASURES: Depression was self-reported and also measured with the Modified Zung Depression Index (MZDI). Somatization was measured with the Modified Somatic Perception Questionnaire (MSPQ). The MZDI and MSPQ scores were used to classify patients as "normal," "at risk," or "distressed" using the Distress and Risk Assessment Method. Somatic dysfunction was assessed using the Outpatient Osteopathic SOAP Note Form. A 100-mm visual analog scale (VAS), the Roland-Morris Disability Questionnaire (RMDQ), and the Medical Outcomes Study Short Form-36 Health Survey (SF-36) were used to measure LBP severity, back-specific functioning, and general health, respectively. RESULTS: There were 53 patients (26%) and 44 patients (22%) who were classified as having depression on the basis of self-reports and the MZDI cut point, respectively. A total of 38 patients (19%) were classified as having somatization on the basis of the MSPQ cut point. There were significant correlations among self-reported depression and the MZDI and MSPQ scores (P<.001 for each pairwise correlation). Similarly, the MZDI and MSPQ scores were both correlated with LBP severity and back-specific disability, and they were inversely correlated with general health (P<.001 for each pairwise correlation). Depression and the number of key osteopathic lesions were also each correlated with back-specific disability and inversely correlated with general health (P<.001 for each pairwise correlation). The MZDI (P=.006) and MSPQ (P=.004) scores were also correlated with the number of key osteopathic lesions. CONCLUSIONS: The associations among depression, somatization, and LBP in this study are consistent with the findings of previous studies. These associations, coupled with the findings that MZDI and MSPQ scores are correlated with somatic dysfunction, may have important implications for the use of osteopathic manual treatment in patients with chronic LBP.

Background and methodology of the Osteopathic Survey of Health Care in America 2010 (OSTEOSURV 2010).

BACKGROUND: The Osteopathic Survey of Health Care in America (OSTEOSURV) is a decennial national telephone survey. Its goals are to monitor longitudinal trends in awareness, beliefs, utilization, and patient satisfaction relating to osteopathic physicians and to assess beliefs and attitudes regarding contemporary health care issues in the United States. The questionnaire was validated during the administrations of OSTEOSURV-I and OSTEOSURV-II in 1998 and 2000, respectively. In OSTEOSURV 2010, the contemporary health care issues of interest are patient-centered care and the Patient Protection and Affordable Care Act of 2010. METHODS: The target population was household residents of the United States aged 18 years or older. A total of 10,308 random landline telephone numbers were dialed using a computer-assisted telephone interviewing system to acquire 1000 completed interviews between July 23, 2010, and October 1, 2010. The response, cooperation, and contact rates as defined by the American Association for Public Opinion Research were comparable to those of other national telephone surveys. The survey provides an estimated margin of error no greater than 3% to 4% for both general items and for those relating to the subset of respondents claiming to be aware of osteopathic physicians. Because respondents were older and more likely to be female than referents in the general population, the observed responses will be weighted by age and sex to reflect the US Census estimates for persons aged 18 years or older in 2010. DISCUSSION: OSTEOSURV 2010 was successfully fielded as the latest national telephone survey relevant to osteopathic medicine and contemporary US health care issues. Data analysis should yield important new findings relating to osteopathic physicians, patient-centered care, and the Patient Protection and Affordable Care Act that may not be readily observed through other national health care data sets. While underrepresented in this survey, which excluded cell phone-only participants, young adult respondents were reflective of their national age referents with regard to health insurance coverage and general health status. Thus, it appears likely that statistical weighting by age and sex of the OSTEOSURV 2010 data will minimize potential bias in estimates of health-related items. Rapidly evolving technology and sociocultural transitions will necessitate changes in the design of OSTEOSURV 2020.