PT-IN-MIND: study protocol for a multisite randomised feasibility trial investigating physical therapy with integrated mindfulness (PT-IN-MIND) for patients with chronic musculoskeletal pain and long-term opioid treatment who attend outpatient physical therapy.

INTRODUCTION: Many individuals receiving outpatient physical therapy have musculoskeletal pain and up to one-third use prescription opioids. The impact of physical therapist-led mindfulness-based interventions integrated with evidence-based physical therapy (I-EPT) to manage patients with chronic musculoskeletal pain and long-term opioid treatment has not been elucidated. This project evaluates the feasibility of conducting a cluster randomised trial to test the effectiveness of I-EPT. METHODS AND ANALYSIS: Study 1 aim: Refine and manualise the I-EPT treatment protocol. Our approach will use semistructured interviews of patients and physical therapists to refine an I-EPT training manual. Study 2 aim: Evaluate different intensities of physical therapist training programmes for the refined I-EPT treatment protocol. Physical therapists will be randomised 1:1:1 to high-intensity training (HighIT), low-IT (LowIT) training and no training arms. Following training, competency in the provision of I-EPT (LowIT and HighIT groups) will be assessed using standardised patient simulations. Study 3 aim: Evaluate the feasibility of the I-EPT intervention across domains of the Reach, Effectiveness, Adoption, Implementation, Maintenance implementation framework. The refined I-EPT treatment protocol will be tested in two different health systems with 90 patients managed by the randomised physical therapists. The coprimary endpoints for study 3 are the proportions of the Pain, Enjoyment of Life and General Activity Scale and the Timeline Followback for opioid use/dose collected at 12 weeks. ETHICS AND DISSEMINATION: Ethics approval for the study was obtained from the University of Utah, University of Florida and Florida State University Institutional Review Boards. Informed consent is required for participant enrolment in all phases of this project. On completion, study data will be made available in compliance with NIH data sharing policies. TRIAL REGISTRATION NUMBER: NCT05875207.

Reliability of the scapular dyskinesis test yes-no classification in asymptomatic individuals between students and expert physical therapists.

BACKGROUND: Scapular dyskinesis is considered a risk factor for the shoulder pain that may warrant screening for prevention. Clinicians of all experience screen scapular dyskinesis using the scapular dyskinesis test yes-no classification (Y-N), yet its reliability in asymptomatic individuals is unknown. We aimed to establish Y-N's intra- and inter-reliability between students and expert physical therapists. METHODS: We utilized a cross-sectional design using consecutive asymptomatic subjects. Six students and two experts rated 100 subjects using the Y-N. Cohen's kappa (κ) and Krippendorff's alpha (K-α) were calculated to determine intra- and inter-rater reliability. RESULTS: Intra- and inter-rater values for experts were κ=0.92 (95% confidence interval [CI], 0.91-0.93) and 0.85 (95% CI, 0.84-0.87) respectively; students were κ=0.77 (95% CI, 0.75-0.78) and K-α=0.63 (95% CI, 0.58-0.67). CONCLUSIONS: The Y-N is reliable in detecting scapular dyskinesis in asymptomatic individuals regardless of experience.

Changes in Pain Catastrophizing and Fear-Avoidance Beliefs as Mediators of Early Physical Therapy on Disability and Pain in Acute Low-Back Pain: A Secondary Analysis of a Clinical Trial.

OBJECTIVE: The Fear-Avoidance Model (FAM) of chronic pain posits that pain catastrophizing and fear-avoidance beliefs are prognostic for disability and chronicity. In acute low-back pain, early physical therapy (PT) is effective in reducing disability in some patients. How early PT impacts short- and long-term changes in disability for patients with acute pain is unknown. Based on the FAM, we hypothesized that early reductions in pain catastrophizing and fear-avoidance beliefs would mediate early PT's effect on changes in disability (primary outcome) and pain intensity (secondary outcome) over 3 months and 1 year. SUBJECTS: Participants were 204 patients with low-back pain of <16 days duration, who enrolled in a clinical trial (NCT01726803) comparing early PT sessions or usual care provided over 4 weeks. METHODS: Patients completed the Pain Catastrophizing Scale (PCS), Fear-Avoidance Beliefs Questionnaire (FABQ work and physical activity scales), and outcomes (Oswestry Disability Index and Numeric Pain Rating Scale) at baseline, 4 weeks, 3 months, and 1 year. We applied longitudinal mediation analysis with single and multiple mediators. RESULTS: Early PT led to improvements in disability and pain over 3 months but not 1 year. In the single mediator model, 4-week reductions in pain catastrophizing mediated early PT's effects on 3-month disability and pain intensity improvements, explaining 16% and 22% of the association, respectively, but the effects were small. Pain catastrophizing and fear-avoidance beliefs did not jointly mediate these associations. CONCLUSIONS: In acute low-back pain, early PT may improve disability and pain outcomes at least partly through reducing patients' catastrophizing.

Effectiveness of training physical therapists in pain neuroscience education for patients with chronic spine pain: a cluster-randomized trial.

ABSTRACT: Chronic spinal pain poses complex challenges for health care around the world and is in need of effective interventions. Pain neuroscience education (PNE) is a promising intervention hypothesized to improve pain and disability by changing individuals' beliefs, perceptions, and expectations about pain. Pain neuroscience education has shown promise in small, controlled trials when implemented in tightly controlled situations. Exploration of promising interventions through more pragmatic methodologies is a crucial but understudied step towards improving outcomes in routine clinical care. The purpose was to examine the impact of pragmatic PNE training on clinical outcomes in patients with chronic spine pain. The cluster-randomized clinical trial took place in 45 outpatient physical therapist (PT) clinics. Participants included 108 physical therapists (45 clinics and 16 clusters) and 319 patients. Clusters of PT clinics were randomly assigned to either receive training in PNE or no intervention and continue with usual care (UC). We found no significant differences between groups for our primary outcome at 12 weeks, Patient-Reported Outcomes Measurement Information System Physical Function computer adaptive test {mean difference = 1.05 (95% confidence interval [CI]: -0.73 to 2.83), P = 0.25}. The PNE group demonstrated significant greater improvements in pain self-efficacy at 12 and 2 weeks compared with no intervention (mean difference = 3.65 [95% CI: 0.00-7.29], P = 0.049 and = 3.08 [95% CI: 0.07 to -6.09], P = 0.045, respectively). However, a similar percentage of participants in both control (41.1%) and treatment (44.4%) groups reported having received the treatment per fidelity question (yes or no to pain discussed as a perceived threat) at 2 weeks. Pragmatic PT PNE training and delivery failed to produce significant functional changes in patients with chronic spinal pain but did produce significant improvement in pain self-efficacy over UC PT.

The Influence of an Opioid Use Disorder on Initiating Physical Therapy for Low Back Pain: A Retrospective Cohort.

OBJECTIVES: Low back pain (LBP) is common among patients with an opioid use disorder (OUD). The extent to which patients with an OUD initiate physical therapy for LBP is unknown. The aim of this study was to examine the association between a history of an OUD and initiation of physical therapy for LBP within 60 days of a primary care provider (PCP) visit for this condition. METHODS: Claims from a single state-wide all payer claims database from June 30, 2013 and August 31, 2015 were used to establish a retrospective cohort of patients who consulted a PCP for a new episode of LBP. The outcome measure was patients who had at least 1 physical therapy claim within 60-days after the PCP visit. After propensity score matching on covariates, logistic regression was used to compare the outcome of patients with a history of an OUD to patients without an OUD. RESULTS: Propensity score matching resulted in 1360 matched pairs of participants. The mean age was 47.2 years (15.9) and 55.9% were female. Compared to patients without an OUD, patients with an OUD were less likely to initiate physical therapy for LBP (adjusted odds ratio  = 0.65, 95% confidence intervals:0.49-0.85). CONCLUSIONS: After a visit to a PCP for a new episode of care for LBP, patients with a history of an OUD are less likely to initiate physical therapy.

Physical Therapy Referral From Primary Care for Acute Back Pain With Sciatica : A Randomized Controlled Trial.

BACKGROUND: Few studies have examined primary care management for acute sciatica, including referral to physical therapy. OBJECTIVE: To evaluate whether early referral to physical therapy reduced disability more than usual care (UC) alone for patients with acute sciatica. DESIGN: Randomized controlled clinical trial. (ClinicalTrials.gov: NCT02391350). SETTING: 2 health care systems in Salt Lake City, Utah. PATIENTS: 220 adults aged 18 to 60 years with sciatica of less than 90 days' duration who were making an initial primary care consultation. INTERVENTION: All participants received imaging and medication at the discretion of the primary care provider before enrollment. A total of 110 participants randomly assigned to UC were provided 1 session of education, and 110 participants randomly assigned to early physical therapy (EPT) were provided 1 education session and then referred for 4 weeks of physical therapy, including exercise and manual therapy. MEASUREMENTS: The primary outcome was the Oswestry Disability Index (OSW) score after 6 months. Secondary outcomes were pain intensity, patient-reported treatment success, health care use, and missed workdays. RESULTS: Participants in the EPT group had greater improvement from baseline to 6 months for the primary outcome (relative difference, -5.4 points [95% CI, -9.4 to -1.3 points]; P = 0.009). The OSW and several secondary outcomes favored EPT after 4 weeks. After 1 year, between-group differences favored EPT for the OSW (relative difference, -4.8 points [CI, -8.9 to -0.7 points]) and back pain intensity (relative difference, -1.0 points [CI, -1.6 to -0.4 points]). The EPT group was more likely to self-report treatment success after 1 year (45.2%) than the UC group (27.6%) (relative risk, 1.6 [CI, 1.1 to 2.4]). There were no significant differences in health care use or missed workdays. LIMITATION: The patients and providers were unblinded, and specific physical therapy interventions responsible for effects could not be determined. CONCLUSION: Referral from primary care to physical therapy for recent-onset sciatica improved disability and other outcomes compared with UC. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

The influence of smoking on recovery from subacromial pain syndrome: a cohort from the Military Health System.

BACKGROUND: Smoking rates are higher in the military population than in the civilian sector. Smoking is associated with poor prognosis for many musculoskeletal injuries. The purpose of this study was to investigate the effects of smoking on recovery from a shoulder injury in a prospective cohort seeking care at a military treatment facility. METHODS: Secondary analysis of 98 patients referred to physical therapy for unilateral shoulder pain. Patients received a corticosteroid injection or 6 sessions of physical therapy. Sociodemographic and historical variables were analyzed to assess their influence on whether a patient achieved the minimally clinically important difference of 12 or more points on the Shoulder Pain and Disability Index following treatment. RESULTS: The mean improvement was almost 50% in both groups and maintained to one year. Smoking was associated with not achieving a clinically significant improvement in disability scores at 4 weeks, but not 6 months. Higher levels of disability at baseline and receiving only the treatment originally assigned (not crossing over) were associated with achieving clinically significant changes at both 4 weeks and 6 months. COMMENT: Smoking is a modifiable variable that may help explain lack of improvement in patients with shoulder pain. Healthcare providers in the military setting should keep this in mind when educating this patient population and determining their prognosis, especially given high rates of smoking. Further research is needed to validate these findings and determine their influence on other musculoskeletal injuries.

Cost-Effectiveness of Primary Care Management With or Without Early Physical Therapy for Acute Low Back Pain: Economic Evaluation of a Randomized Clinical Trial.

STUDY DESIGN: Economic evaluation of a randomized clinical trial. OBJECTIVE: Compare costs and cost-effectiveness of usual primary care management for patients with acute low back pain (LBP) with or without the addition of early physical therapy. SUMMARY OF BACKGROUND DATA: Low back pain is among the most common and costly conditions encountered in primary care. Early physical therapy after a new primary care consultation for acute LBP results in small clinical improvement but cost-effectiveness of a strategy of early physical therapy is unknown. METHODS: Economic evaluation was conducted alongside a randomized clinical trial of patients with acute, nonspecific LBP consulting a primary care provider. All patients received usual primary care management and education, and were randomly assigned to receive four sessions of physical therapy or usual care of delaying referral consideration to permit spontaneous recovery. Data were collected in a randomized trial involving 220 participants age 18 to 60 with LBP <16 days duration without red flags or signs of nerve root compression. The EuroQoL EQ-5D health states were collected at baseline and after 1-year and used to compute the quality adjusted life year (QALY) gained. Direct (health care utilization) and indirect (work absence or reduced productivity) costs related to LBP were collected monthly and valued using standard costs. The incremental cost-effectiveness ratio was computed as incremental total costs divided by incremental QALYs. RESULTS: Early physical therapy resulted in higher total 1-year costs (mean difference in adjusted total costs = $580, 95% CI: $175, $984, P = 0.005) and better quality of life (mean difference in QALYs = 0.02, 95% CI: 0.005, 0.35, P = 0.008) after 1-year. The incremental cost-effectiveness ratio was $32,058 (95% CI: $10,629, $151,161) per QALY. CONCLUSION: Our results support early physical therapy as cost-effective relative to usual primary care after 1 year for patients with acute, nonspecific LBP. LEVEL OF EVIDENCE: 2.

Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial.

IMPORTANCE: Low back pain (LBP) is common in primary care. Guidelines recommend delaying referrals for physical therapy. OBJECTIVE: To evaluate whether early physical therapy (manipulation and exercise) is more effective than usual care in improving disability for patients with LBP fitting a decision rule. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial with 220 participants recruited between March 2011 and November 2013. Participants with no LBP treatment in the past 6 months, aged 18 through 60 years (mean age, 37.4 years [SD, 10.3]), an Oswestry Disability Index (ODI) score of 20 or higher, symptom duration less than 16 days, and no symptoms distal to the knee in the past 72 hours were enrolled following a primary care visit. INTERVENTIONS: All participants received education. Early physical therapy (n = 108) consisted of 4 physical therapy sessions. Usual care (n = 112) involved no additional interventions during the first 4 weeks. MAIN OUTCOMES AND MEASURES: Primary outcome was change in the ODI score (range: 0-100; higher scores indicate greater disability; minimum clinically important difference, 6 points) at 3 months. Secondary outcomes included changes in the ODI score at 4-week and 1-year follow-up, and change in pain intensity, Pain Catastrophizing Scale (PCS) score, fear-avoidance beliefs, quality of life, patient-reported success, and health care utilization at 4-week, 3-month, and 1-year follow-up. RESULTS: One-year follow-up was completed by 207 participants (94.1%). Using analysis of covariance, early physical therapy showed improvement relative to usual care in disability after 3 months (mean ODI score: early physical therapy group, 41.3 [95% CI, 38.7 to 44.0] at baseline to 6.6 [95% CI, 4.7 to 8.5] at 3 months; usual care group, 40.9 [95% CI, 38.6 to 43.1] at baseline to 9.8 [95% CI, 7.9 to 11.7] at 3 months; between-group difference, -3.2 [95% CI, -5.9 to -0.47], P = .02). A significant difference was found between groups for the ODI score after 4 weeks (between-group difference, -3.5 [95% CI, -6.8 to -0.08], P = .045]), but not at 1-year follow-up (between-group difference, -2.0 [95% CI, -5.0 to 1.0], P = .19). There was no improvement in pain intensity at 4-week, 3-month, or 1-year follow-up (between-group difference, -0.42 [95% CI, -0.90 to 0.02] at 4-week follow-up; -0.38 [95% CI, -0.84 to 0.09] at 3-month follow-up; and -0.17 [95% CI, -0.62 to 0.27] at 1-year follow-up). The PCS scores improved at 4 weeks and 3 months but not at 1-year follow-up (between-group difference, -2.7 [95% CI, -4.6 to -0.85] at 4-week follow-up; -2.2 [95% CI, -3.9 to -0.49] at 3-month follow-up; and -0.92 [95% CI, -2.7 to 0.61] at 1-year follow-up). There were no differences in health care utilization at any point. CONCLUSIONS AND RELEVANCE: Among adults with recent-onset LBP, early physical therapy resulted in statistically significant improvement in disability, but the improvement was modest and did not achieve the minimum clinically important difference compared with usual care. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01726803.

Initial management decisions after a new consultation for low back pain: implications of the usage of physical therapy for subsequent health care costs and utilization.

OBJECTIVES: To describe the utilization of physical therapy following a new primary care consultation for low back pain (LBP) and to examine the relations between physical therapy utilization and other variables with health care utilization and costs in the year after consultation. DESIGN: Retrospective cohort obtained from electronic medical records and insurance claims data. SETTING: Single health care delivery system. PARTICIPANTS: Individuals (N=2184) older than 18 years with a new consultation for LBP from 2004 to 2008. INTERVENTIONS: Patients were categorized as receiving initial physical therapy management if care occurred within 14 days after consultation. MAIN OUTCOME MEASURES: Total health care costs for all LBP-related care received in the year after consultation were calculated from claims data. Predictors of utilization of emergency care, advanced imaging, epidural injections, specialist visits, and surgery were identified using multivariate logistic regression. The generalized linear model was used to compare LBP-related costs based on physical therapy utilization and identify other cost determinants. RESULTS: Initial physical therapy was received by 286 of the 2184 patients (13.1%), and was not a determinant of LBP-related health care costs or utilization of specific services in the year after consultation. Older age, mental health, or neck pain comorbidity and initial management with opioids were determinants of cost and several utilization outcomes. CONCLUSIONS: Initial physical therapy management was not associated with increased health care costs or utilization of specific services following a new primary care LBP consultation. Additional research is needed to examine the cost consequences of initial management decisions made following a new consultation for LBP.

The relationship of transversus abdominis and lumbar multifidus activation and prognostic factors for clinical success with a stabilization exercise program: a cross-sectional study.

UNLABELLED: Hebert JJ, Koppenhaver SL, Magel JS, Fritz JM. The relationship of transversus abdominis and lumbar multifidus activation and prognostic factors for clinical success with a stabilization exercise program: a cross-sectional study. OBJECTIVE: To examine the relationship between prognostic factors for clinical success with a stabilization exercise program and lumbar multifidus (LM) and transversus abdominis (TrA) muscle activation assessed using rehabilitative ultrasound imaging (RUSI). DESIGN: Cross-sectional study. SETTING: Outpatient physical therapy clinic. PARTICIPANTS: Volunteers with current low back pain (N=40). INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: We examined the relationship between prognostic factors associated with clinical success with a stabilization exercise program (positive prone instability test, age <40y, aberrant movements, straight leg raise >91 degrees , presence of lumbar hypermobility) and degree of TrA and LM muscle activation assessed by RUSI. RESULTS: Significant univariate relationships were identified between LM muscle activation and the number of prognostic factors present (Pearson correlation coefficient [r] =-.558, P=.001), as well as the individual factors of a positive prone instability test (point biserial correlation coefficient [r(pbis)]=.376, P=.018) and segmental hypermobility (r(pbis)=.358, P=.025). The multivariate analyses indicated that after controlling for other variables, the addition of the variable "number of prognostic factors present" resulted in a significant increase in R(2) (P=.006). No significant univariate or multivariate relationships were observed between the prognostic factors and TrA muscle activation. CONCLUSIONS: Decreased LM muscle activation, but not TrA muscle activation, is associated with the presence of factors predictive of clinical success with a stabilization exercise program. Our findings provide researchers and clinicians with evidence regarding the construct validity of the prognostic factors examined in this study, as well as the potential clinical importance of the LM muscle as a target for stabilization exercises.

Reliability of rehabilitative ultrasound imaging of the transversus abdominis and lumbar multifidus muscles.

OBJECTIVES: To evaluate the intraexaminer and interexaminer reliability of rehabilitative ultrasound imaging (RUSI) in obtaining thickness measurements of the transversus abdominis (TrA) and lumbar multifidus muscles at rest and during contractions. DESIGN: Single-group repeated-measures reliability study. SETTING: University and orthopedic physical therapy clinic. PARTICIPANTS: A volunteer sample of adults (N=30) with current nonspecific low back pain (LBP) was examined by 2 clinicians with minimal RUSI experience. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Thickness measurements of the TrA and lumbar multifidus muscles at rest and during contractions were obtained by using RUSI during 2 sessions 1 to 3 days apart. Percent thickness change was calculated as thickness(contracted)-thickness(rest)/thickness(rest). Intraclass correlation coefficients (ICC) were used to estimate reliability. RESULTS: By using the mean of 2 measures, intraexaminer reliability point estimates (ICC(3,2)) ranged from 0.96 to 0.99 for same-day comparisons and from 0.87 to 0.98 for between-day comparisons. Interexaminer reliability estimates (ICC(2,2)) ranged from 0.88 to 0.94 for within-day comparisons and from 0.80 to 0.92 for between-day comparisons. Reliability estimates comparing measurements by the 2 examiners of the same image (ICC(2,2)) ranged from 0.96 to 0.98. Reliability estimates were lower for percent thickness change measures than the corresponding single thickness measures for all conditions. CONCLUSIONS: RUSI thickness measurements of the TrA and lumbar multifidus muscles in patients with LBP, when based on the mean of 2 measures, are highly reliable when taken by a single examiner and adequately reliable when taken by different examiners.