Sean P. Riley

Short-term effects of thoracic spinal manipulations and message conveyed by clinicians to patients with musculoskeletal shoulder symptoms: a randomized clinical trial

Abstract Study design: Randomized clinical trial. Objectives: To evaluate the effects of high-velocity, low-amplitude thrust manipulations (HVLATMs) and various messages on patients with musculoskeletal shoulder symptoms. Background: Previous studies indicated that HVLATM directed at the thoracic spine and ribs resulted in improvements of shoulder range of motion, pain, and disability in patients with musculoskeletal shoulder symptoms. These studies did not explore if the outcome was dependent on thrust location, clinician communication with the patient, or if there were any lasting effects. Methods: A consecutive sample of 100 patients with shoulder pain was randomized into four groups. Patients received one intervention session including: six thoracic HVLATM (spine versus scapula), a message about HVLATM (neutral versus positive), and standardized home exercises. Outcome measures included shoulder Numeric Pain Rating Scale (NPRS), NPRS with impingement testing, and Shoulder Pain and Disability Index (SPADI). Measurements were recorded prior to intervention, immediately following intervention, and at short-term follow-up. Kruskal–Wallis statistics were used for between-group comparisons and Wilcoxon signed ranks for within-group comparisons. Results: Eighty-eight patients (22 per group) completed the study. Statistically significant differences were found for within-group comparisons for most time points assessed. No statistical differences were found for between-group comparisons. Conclusion: Patients improved following the interventions. Neither the type of HVLATM nor the message conveyed to the patients had a significant effect on the patients’ improvements. Level of evidence: 1b

The Shoulder Pain and Disability Index: Is it sensitive and responsive to immediate change?

BACKGROUND The Shoulder Pain and Disability Index (SPADI) is designed to detect changes in shoulder pain and disability after a one-week interval. With the new Medicare guideline, the SPADI may have to be employed for time frames of less than one week. PURPOSE To determine if the SPADI or its subscales could detect immediate changes in pain and function after a thoracic manipulative intervention known to produce short-term improvement and by comparing it to changes on the numeric pain rating scale (NPRS). METHODS Subjects with primary complaints of non-post-surgical shoulder pain completed the NPRS and the SPADI prior to and immediately following interventions. FINDINGS The SPADI pain subscale detected statistically significant differences that were also detected using the NPRS. In addition, the SPADI pain score and the NPRS scores were moderately correlated between the pre-intervention SPADI and NPRS scores (r = 0.49-0.61, p < 0.001) and post-intervention SPADI and NPRS scores (r = 0.49-0.67, p < 0.001). These differences did not appear to be sensitive or responsive to immediate change. CLINICAL RELEVANCE Since the SPADI may have to be employed in durations of less than one week secondary to third party payer requirements, it is valuable to validate the SPADI for this particular use. CONCLUSION Although SPADI scores demonstrated low sensitivity and responsiveness to immediate changes, the SPADI pain scale was able to detect changes in durations of less than one week. This finding should be confirmed through further prospective experimentation.

Improving completeness and transparency of reporting in clinical trials using the template for intervention description and replication (TIDieR) checklist will benefit the physiotherapy profession

To cite this article: Tiê Yamato, Chris Maher, Bruno Saragiotto, Anne Moseley, Tammy Hoffmann, Mark Elkins, Shannon Petersen, Sean Riley & Jean-Michel Brismée (2016) Improving completeness and transparency of reporting in clinical trials using the template for intervention description and replication (TIDieR) checklist will benefit the physiotherapy profession, Journal of Manual & Manipulative Therapy, 24:4, 183-184, DOI: 10.1080/10669817.2016.1210343 To link to this article: http://dx.doi.org/10.1080/10669817.2016.1210343

Selectivity of physiotherapist programs in the United States does not differ by institutional funding source or research activity level

Purpose: This study aimed to compare selectivity characteristics among institution characteristics to determine differences by institutional funding source (public vs. private) or research activity level (research vs. non-research). Methods: This study included information provided by the Commission on Accreditation in Physical Therapy Education (CAPTE) and the Federation of State Boards of Physical Therapy. Data were extracted from all students who graduated in 2011 from accredited physical therapy programs in the United States. The public and private designations of the institutions were extracted directly from the classifications from the ‘CAPTE annual accreditation report,’ and high and low research activity was determined based on Carnegie classifications. The institutions were classified into four groups: public/research intensive, public/non-research intensive, private/research intensive, and private/non-research intensive. Descriptive and comparison analyses with post hoc testing were performed to determine whether there were statistically significant differences among the four groups. Results: Although there were statistically significant baseline grade point average differences among the four categorized groups, there were no significant differences in licensure pass rates or for any of the selectivity variables of interest. Conclusion: Selectivity characteristics did not differ by institutional funding source (public vs. private) or research activity level (research vs. non-research). This suggests that the concerns about reduced selectivity among physiotherapy programs, specifically the types that are experiencing the largest proliferation, appear less warranted.

Retrospective analysis of physical therapy utilization by the specificity of the diagnosis and order written on the referral

ABSTRACT Background: Arguments against reimbursement for direct access to physical therapy (PT) are that a physician examination is necessary to diagnose and that there is a potential for increased cost. Objective: To determine what percentage of PT referrals had a specific diagnosis and treatment orders. Additionally, specific and non-specific diagnoses and treatment orders were compared in regards to PT units billed, average visits per referral, and average cost per referral. Methods: The charts of 1,000 patients treated in outpatient PT underwent a retrospective chart review. Interferential statistics were used to determine if there was a statistically significant difference between specific and non-specific diagnoses and treatment orders in regard to PT units billed, average visits per referral, and average cost per referral. Results: Twenty-nine percent of all referring diagnoses were non-specific in nature and 58% contained treatment orders that were non-specific. Charts with a specific diagnosis had a statistically significant higher utilization as compared to non-specific diagnoses (p ≤ 0.001). Patients with a specific treatment order also displayed a statistically significant larger average in billed units, average visits per referral, and average reimbursement per referral than those without a specific treatment order (p ≤ 0.0001). Conclusion: Our findings suggest that a physician diagnosis and referral may not be required to direct care for patients seeking PT services. Third-party payers that require a physician referral for PT services may be delaying access to healthcare and increasing costs.

Reliability and Relationship of the Fear-Avoidance Beliefs Questionnaire with the Shoulder Pain and Disability Index and Numeric Pain Rating Scale in Patients with Shoulder Pain

ABSTRACT Purpose: The purpose of this study was to determine: 1) the test–retest reliability of Fear-Avoidance Beliefs Questionnaire (FABQ) Work (FABQW) subscale, FABQ Physical Activity (FABQPA) subscale, Shoulder Pain and Disability Index (SPADI) Pain subscale, SPADI Disability subscale, and Numeric Pain Rating scale (NPRS); and 2) the relationship between the FABQPA, FABQW, SPADI pain, SPADI disability, and NPRS after 4 weeks of pragmatically applied physical therapy (PT) in patients with shoulder pain. Design: Prospective, single-group observational design. Methods: Data were collected at initial evaluation, the first follow-up visit prior to the initiation of treatment, and after 4 weeks of treatment. Results: Statistically significant Intraclass Correlation Coefficient (ICC2,1) values were reported for the FABQPA, FABQW, SPADI Pain, SPADI Disability, and NPRS. A statistically significant moderate relationship between the FABQPA subscale, SPADI subscale, and NPRS could not be established prior to and after 4 weeks of pragmatically applied PT. Statistically significant differences were observed between the initial evaluation and four-week follow-up for the FABQPA, SPADI Pain, SPADI Disability, and NPRS (p < 0.01). Discussion: Since a meaningful relationship between the FABQ, SPADI, and NPRS did not exist, it suggests that the FABQPA may be measuring a metric other than pain. Conclusions: This study suggests that the FABQW may not be sensitive to change over time.

Are movement-based classification systems more effective than therapeutic exercise or guideline based care in improving outcomes for patients with chronic low back pain? A systematic review

ABSTRACT Objectives: The purpose of this systematic review was to determine if movement-based classification (MBC) systems are more effective than therapeutic exercise or guideline-based care (GBC) in improving outcomes in patients with low back pain (LBP) based upon randomized clinical trials (RCT) with moderate to high methodological quality and low to moderate risk of bias. Methods: The search strategy was developed by a librarian experienced in systematic review methodology and peer reviewed by a second research librarian. The following databases were searched from their inception to May 17, 2018: PubMed, Embase, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform. The identified RCTs with a PEDro score of ≥6 were screened and assessed for risk of bias by two blinded individual reviewers using Covidence. Results: Seven studies were identified that had moderate-to-high methodological quality. One of the studies was identified as having a high risk of bias. Of the six studies that remained, only one study reported finding a statistically significant difference at the immediate follow-up that was not clinically significant. There was no significance at 6 and 12 months. Discussion: There is a paucity of moderate to high methodological quality RCTs with similar methodology that compare MBC to standard of care treatments for patients with LBP. Studies with moderate to high methodological quality that have a low risk of bias do not support MBCs as being superior to general exercise or GBC in the treatment of nonradicular LBP. Level of Evidence: 1a

Manual unloading of the lumbar spine: can it identify immediate responders to mechanical traction in a low back pain population? A study of reliability and criterion referenced predictive validity

Background:: To date, no research has examined the reliability or predictive validity of manual unloading tests of the lumbar spine to identify potential responders to lumbar mechanical traction. Purpose:: To determine: (1) the intra and inter-rater reliability of a manual unloading test of the lumbar spine and (2) the criterion referenced predictive validity for the manual unloading test. Methods:: Ten volunteers with low back pain (LBP) underwent a manual unloading test to establish reliability. In a separate procedure, 30 consecutive patients with LBP (age 50·86±11·51) were assessed for pain in their most provocative standing position (visual analog scale (VAS) 49·53±25·52 mm). Patients were assessed with a manual unloading test in their most provocative position followed by a single application of intermittent mechanical traction. Post traction, pain in the provocative position was reassessed and utilized as the outcome criterion. Results:: The test of unloading demonstrated substantial intra and inter-rater reliability K = 1·00, P = 0·002, K = 0·737, P = 0·001, respectively. There were statistically significant within group differences for pain response following traction for patients with a positive manual unloading test (P<0·001), while patients with a negative manual unloading test did not demonstrate a statistically significant change (P>0·05). There were significant between group differences for proportion of responders to traction based on manual unloading response (P = 0·031), and manual unloading response demonstrated a moderate to strong relationship with traction response Phi = 0·443, P = 0·015. Discussion and conclusion:: The manual unloading test appears to be a reliable test and has a moderate to strong correlation with pain relief that exceeds minimal clinically important difference (MCID) following traction supporting the validity of this test.

Is research quality in orthopedic manual therapy trials stagnating? Reflections and pathways for improving research quality and advance our profession.

(TIDieR) checklist in addition to the CONSORT guidelines for reporting of randomized clinical trials (RCTs).[18] Our study [19] published in this issue of JMMT suggests that part of the problem may be that reporting guidelines such as the CONSORT are unreliable and subjective in nature. Will the addition of the TIDieR checklist to the CONSORT help improve the reliability and completeness of reporting in RCTs? Identifying the reliability of the CONSORT with the addition of the TIDieR checklist may help identify the strengths and weaknesses of this new instrument, help in the evolution of this new tool, and ultimately improve the reporting of clinical trials. We urge reviewers and journal editorial board members to be attentive to the completeness of the reporting of trials when critically appraising manuscripts. We urge clinicians and researchers planning their study to (1) register their observational study, clinical trial to clinicaltrials.gov before the start of data collection. This allows public viewing and optimal trial scrutiny; (2) include CONSORT, STROBE, STARD, and other reporting tools upon manuscript submission. Those should be submitted as Appendices that JMMT publishes electronically; (3) use Appendices to provide data required in the reporting tools when authors experience difficulties meeting the maximum number of words allowed for manuscript length. These data will be published electronically. Taking these few steps may help raise research quality and transparency of published trials and hopefully will lead to systematic reviews and meta-analyses able to conclude about the effectiveness or no effectiveness of tested interventions. This will improve research scientific rigor and help advance our profession.

Re: "Determining the level of evidence for the effectiveness of spinal manipulation in the upper limb: A systematic review meta-analysis".

We recently read a very interesting article that is in press in Manual Therapy titled, “Determining the level of evidence for the effectiveness of spinal manipulation in the upper limb: A systematic review and meta-analysis”. (Aoyagi et al., in press) The authors should be commended for their work. (Aoyagi et al., in press) cite a study by (Riley et al., 2015) titled, “Short-term effects of thoracic spinal manipulations and message conveyed by clinicians to patients with musculoskeletal shoulder symptoms: a randomized clinical trial” (Riley et al., 2015) In their review and metaanalysis, (Aoyagi et al., in press) use the PEDro scale and the Risk of bias summary to evaluate the research studies. On both of these scales, the authors report that the (Riley et al., 2015) study did not meet the criteria of either blinding of patients or a blind assessor. Since none of the studies in their reviewmet the criteria of having a blind assessor, we are unsure how (Aoyagi et al., in press) graded this criteria. In Section 2.6 of their paper they report, “As the primary outcome in this study was pain intensity, which is a subjectivemeasure, blinding of outcome assessors were unsatisfied unless patients were blinded.” (Aoyagi et al., in press) This is consistent with the PEDro scoring guidelines, (PEDro scale, 2015) which state “In trials in which key outcomes are self-reported (eg, visual analogue scale, pain diary), the assessor is considered to be blind if the subject was blind”. However, the following sentence is found in the methods section of (Riley et al., 2015) manuscript on page 2: “The therapist performing the examination was blinded to group allocation, and performed all measures before the interventions, immediately following the interventions and at a short-term follow-up.” (Riley et al., 2015). In the case of Riley et al., 2015, subjects were randomly assigned to one of two similar treatment arms, specifically to address the concern of patient blinding. Indeed, in their discussion (Aoyagi et al., in press) state, “Riley et al. (in press) employed scapular manipulation as a control intervention. However, due to the close relationship between the scapula and thoracic spine, as the authors stated, it may have resulted in inducing similar impulses as SM.” While it is difficult to implement a convincing sham manipulation, if these two interventions were in fact so