John C. Licciardone

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 Health outcomes In Chronic low back pain: The OSTEOPATHIC Trial

BackgroundOsteopathic manipulative treatment (OMT) and ultrasound physical therapy (UPT) are commonly used for chronic low back pain. Although there is evidence from a systematic review and meta-analysis that OMT generally reduces low back pain, there are no large clinical trials that specifically assess OMT efficacy in chronic low back pain. Similarly, there is a lack of evidence involving UPT for chronic low back pain.MethodsThe OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial is a Phase III randomized controlled trial that seeks to study 488 subjects between August 2006 and June 2010. It uses a 2 × 2 factorial design to independently assess the efficacy of OMT and UPT for chronic low back pain. The primary outcome is a visual analogue scale score for pain. Secondary outcomes include back-specific functioning, generic health, work disability, and satisfaction with back care.ConclusionThis randomized controlled trial will potentially be the largest involving OMT. It will provide long awaited data on the efficacy of OMT and UPT for chronic low back pain.Trial registrationhttp://www.clinicaltrials.gov, NCT00315120

Recovery From Chronic Low Back Pain After Osteopathic Manipulative Treatment: A Randomized Controlled Trial

CONTEXT Little is known about recovery after spinal manipulation in patients with low back pain (LBP). OBJECTIVE To assess recovery from chronic LBP after a short regimen of osteopathic manipulative treatment (OMT) in a responder analysis of the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial. METHODS A randomized double-blind, sham-controlled trial was conducted to determine the efficacy of 6 OMT sessions over 8 weeks. Recovery was assessed at week 12 using a composite measure of pain recovery (10 mm or less on a 100-mm visual analog scale) and functional recovery (2 or less on the Roland-Morris Disability Questionnaire for back-specific functioning). The RRs and numbers-needed-to-treat (NNTs) for recovery with OMT were measured, and corresponding cumulative distribution functions were plotted according to baseline LBP intensity and back-specific functioning. Multiple logistic regression was used to compute the OR for recovery with OMT while simultaneously controlling for potential confounders. Sensitivity analyses were performed to corroborate the primary results. RESULTS There were 345 patients who met neither of the recovery criteria at baseline in the primary analyses and 433 patients who met neither or only 1 of these criteria in the sensitivity analyses. There was a large treatment effect for recovery with OMT (RR, 2.36; 95% CI, 1.31-4.24; P=.003), which was associated with a clinically relevant NNT (8.9; 95% CI, 5.4-25.5). This significant finding persisted after adjustment for potential confounders (OR, 2.92; 95% CI, 1.43-5.97; P=.003). There was also a significant interaction effect between OMT and comorbid depression (P=.02), indicating that patients without depression were more likely to recover from chronic LBP with OMT (RR, 3.21; 95% CI, 1.59-6.50; P<.001) (NNT, 6.5; 95% CI, 4.2-14.5). The cumulative distribution functions demonstrated optimal RR and NNT responses in patients with moderate to severe levels of LBP intensity and back-specific dysfunction at baseline. Similar results were observed in the sensitivity analyses. CONCLUSIONS The OMT regimen was associated with significant and clinically relevant measures for recovery from chronic LBP. A trial of OMT may be useful before progressing to other more costly or invasive interventions in the medical management of patients with chronic LBP. (ClinicalTrials.gov number NCT00315120).

Prevention of progressive back-specific dysfunction during pregnancy: an assessment of osteopathic manual treatment based on Cochrane Back Review Group criteria.

CONTEXT Back pain during pregnancy may be associated with deficits in physical functioning and disability. Research indicates that osteopathic manual treatment (OMT) slows the deterioration of back-specific functioning during pregnancy. OBJECTIVE To measure the treatment effects of OMT in preventing progressive back-specific dysfunction during the third trimester of pregnancy using criteria established by the Cochrane Back Review Group. DESIGN A randomized sham-controlled trial including 3 parallel treatment arms: usual obstetric care and OMT (UOBC+OMT), usual obstetric care and sham ultrasound therapy (UOBC+SUT), and usual obstetric care (UOBC). SETTING The Osteopathic Research Center within the University of North Texas Health Science Center in Fort Worth. PARTICIPANTS A total of 144 patients were randomly assigned and included in intention-to-treat analyses. MAIN OUTCOME MEASURES Progressive back-specific dysfunction was defined as a 2-point or greater increase in the Roland-Morris Disability Questionnaire (RMDQ) score during the third trimester of pregnancy. Risk ratios (RRs) and 95% confidence intervals (CIs) were used to compare progressive back-specific dysfunction in patients assigned to UOBC+OMT relative to patients assigned to UOBC+SUT or UOBC. Numbers needed to treat (NNTs) and 95% CIs were also used to assess UOBC+OMT vs each comparator. Subgroup analyses were performed using median splits of baseline scores on a numerical rating scale for back pain and the RMDQ. RESULTS Overall, 68 patients (47%) experienced progressive back-specific dysfunction during the third trimester of pregnancy. Patients who received UOBC+OMT were significantly less likely to experience progressive back-specific dysfunction (RR, 0.6; 95% CI, 0.3-1.0; P=.046 vs UOBC+SUT; and RR, 0.4; 95% CI, 0.2-0.7; P<.0001 vs UOBC). The effect sizes for UOBC+OMT vs UOBC+SUT and for UOBC+OMT vs UOBC were classified as medium and large, respectively. The corresponding NNTs for UOBC+OMT were 5.1 (95% CI, 2.7-282.2) vs UOBC+SUT; and 2.5 (95% CI, 1.8-4.9) vs UOBC. There was no statistically significant interaction between subgroups in response to OMT. CONCLUSION Osteopathic manual treatment has medium to large treatment effects in preventing progressive back-specific dysfunction during the third trimester of pregnancy. The findings are potentially important with respect to direct health care expenditures and indirect costs of work disability during pregnancy.

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.

Non-thrust manual therapy reduces erector spinae short-latency stretch reflex asymmetries in patients with chronic low back pain

The purpose of this study was to determine if non-thrust manual therapy (MT) attenuated side-to-side differences (asymmetry) of the erector spinae (ES) stretch reflex amplitude in nine patients with chronic LBP. We used electromechanical tapping to elicit short-latency stretch reflexes (SR) from the ES muscles before and after non-thrust MT. A large asymmetry in the SR was observed at baseline, with the higher of the paraspinal sides exhibiting a 100.2±28.2% greater value than the lower side. Following the intervention, this SR asymmetry was reduced (100.2±28.2% to 36.6±23.1%; p=0.03). This change was largely due to reduced amplitude on the side that was higher at baseline (35% reduction following treatment; p=0.05), whereas no change over time was observed in the low side (p=0.23). Additionally, there was no difference between the respective sides following the intervention (p=0.38), indicating that the asymmetry was normalized following treatment. These findings provide insight into the mechanism(s) of action of non-thrust MT, and suggest that it acts to down regulate the gain of the muscle spindles and/or the various sites of the Ia reflex pathway. Ultimately, developing a better understanding of the physiologic effects of manual therapies will assist in optimizing treatment strategies for patients with LBP.

Targeting Patient Subgroups With Chronic Low Back Pain for Osteopathic Manipulative Treatment: Responder Analyses From a Randomized Controlled Trial

CONTEXT Osteopathic manipulative treatment (OMT) is often used to treat patients with low back pain (LBP). OBJECTIVE To identify subgroups of patients with chronic LBP who achieve medium to large treatment effects with OMT based on responder analyses involving pain and functioning outcomes from the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial. METHODS This randomized, double-blind, sham-controlled trial involving 455 patients in Dallas-Fort Worth was conducted from 2006 to 2011. A 100-mm visual analog scale (VAS) for LBP intensity and the Roland-Morris Disability Questionnaire (RMDQ) for back-specific functioning were used to assess primary and secondary outcomes, respectively. Substantial improvement was defined as 50% or greater reduction at week 12 compared with baseline. Cumulative distribution functions for the RR and number-needed-to-treat (NNT) were used to assess response. RESULTS Medium treatment effects for LBP intensity were observed overall (RR, 1.41; 95% CI, 1.13-1.76; P=.002; NNT, 6.9; 95% CI, 4.3-18.6). However, large treatment effects were observed in patients with baseline VAS scores of 35 mm or greater. Although OMT was not associated with overall substantial improvement in back-specific functioning, patients with baseline RMDQ scores of 7 or greater experienced medium effects, and patients with baseline scores 16 or greater experienced large effects that were significant. The OMT effects for LBP intensity and back-specific functioning were independent of baseline patient demographic characteristics, comorbid medical conditions, and medication use for LBP during the trial. CONCLUSIONS Subgrouping according to baseline levels of chronic LBP intensity and back-specific functioning appears to be a simple strategy for identifying sizeable numbers of patients who achieve substantial improvement with OMT and may thereby be less likely to use more costly and invasive interventions. (ClinicalTrials.gov number NCT00315120).

Short-term dosing of manual therapies for chronic low back pain

In their dose-response and efficacy trial of spinal manipulative therapy (SMT) in patients with chronic nonspecific low back pain (LBP), Haas et al. [1] concluded that 12 treatment sessions are the best dose within a 12-week end point. This was largely based on responder analysis wherein 50% of patients achieved at least 50% pain improvement with this dose of chiropractic treatment, which consisted primarily of high-velocity low-amplitude thrust techniques. In comparison with 0 sessions (control), significantly more patients responded to this 12-session regimen but not to the 6or 18-session regimens. By contrast, the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) trial involving 455 patients demonstrated that comparable pain improvement can be achieved at 12 weeks with only six osteopathic manual treatment (OMT) sessions [2]. The significant pain reductions with OMT, which were clinically relevant according to guidelines established by the Cochrane Back Review group [3], were corroborated by decreased use of prescription rescue medication for LBP and high levels of satisfaction with back care during the trial among patients receiving OMT [2]. Moreover, subgroup analyses have demonstrated large treatment effects in reducing LBP and clinically important improvements in back-specific functioning with this 6-session OMT regimen in patients with high levels of baseline LBP [4]. There is limited information on cost-effectiveness of interventions for LBP [5], and clinical practice guidelines on SMT in the management of LBP vary across nations [6]. Thus, recommendations on dosing of manual therapies have potentially important implications not only for guiding future efficacy trials but also for assessing cost-effectiveness and refining clinical practice guidelines. A joint clinical practice guideline from the American College of Physicians and the American Pain Society issued a Grade B recommendation (based on good evidence for a moderate net benefit with SMT) that clinicians consider using SMT in patients with chronic LBP who do not improve with self-care options [7]. Another guideline on early management of persistent nonspecific LBP from the National Institute for Health and Care Excellence subsequently recommended offering a course of manual therapy comprising up to nine treatment sessions over a period of up to 12 weeks [8]. Why were Haas et al. [1] unable to replicate the shortterm pain improvements achieved with only six OMT sessions [2], which were well within the National Institute for Health and Care Excellence dosing guideline? [8] A likely explanation is that the multimodal approach used in the OMT protocol did not rely primarily on high-velocity low-amplitude thrusts in the lumbar and transitional thoracic regions. Rather, it also included moderatevelocity moderate-amplitude thrusts; soft-tissue stretching, kneading, and pressure; myofascial stretching and release; positional treatment of myofascial tender points; and muscle energy treatment. These techniques were targeted at the lumbosacral, iliac, and pubic regions. This treatment philosophy is important because patients with chronic LBP have multifocal dysfunctions involving the lumbar, sacral, pelvic, and innominate regions that are associated with LBP and back-specific disability [9]. Nevertheless, several techniques in the OMT protocol have been accepted for LBP treatment by professional organizations representing chiropractors and physiotherapists [10]. Thus, the OSTEOPATHIC trial protocol, dosing, and results may be generalizable to other manual therapy practitioners.