The World Federation of Chiropractic Global Patient Safety Task Force: a call to action.

BACKGROUND: The Global Patient Safety Action Plan, an initiative of the World Health Organization (WHO), draws attention to patient safety as being an issue of utmost importance in healthcare. In response, the World Federation of Chiropractic (WFC) has established a Global Patient Safety Task Force to advance a patient safety culture across all facets of the chiropractic profession. This commentary aims to introduce principles and call upon the chiropractic profession to actively engage with the Global Patient Safety Action Plan beginning immediately and over the coming decade. MAIN TEXT: This commentary addresses why the chiropractic profession should pay attention to the WHO Global Patient Safety Action Plan, and what actions the chiropractic profession should take to advance these objectives. Each strategic objective identified by WHO serves as a focal point for reflection and action. Objective 1 emphasizes the need to view each clinical interaction as a chance to improve patient safety through learning. Objective 2 urges the implementation of frameworks that dismantle systemic obstacles, minimizing human errors and strengthening patient safety procedures. Objective 3 supports the optimization of clinical process safety. Objective 4 recognizes the need for patient and family engagement. Objective 5 describes the need for integrated patient safety competencies in training programs. Objective 6 explains the need for foundational data infrastructure, ecosystem, and culture. Objective 7 emphasizes that patient safety is optimized when healthcare professionals cultivate synergy and partnerships. CONCLUSIONS: The WFC Global Patient Safety Task Force provides a structured framework for aligning essential considerations for patient safety in chiropractic care with WHO strategic objectives. Embracing the prescribed action steps offers a roadmap for the chiropractic profession to nurture an inclusive and dedicated culture, placing patient safety at its core. This commentary advocates for a concerted effort within the chiropractic community to commit to and implement these principles for the collective advancement of patient safety.

Waste not, want not: call to action for spinal manipulative therapy researchers.

BACKGROUND: Research waste is defined as research outcomes with no or minimal societal benefits. It is a widespread problem in the healthcare field. Four primary sources of research waste have been defined: (1) irrelevant or low priority research questions, (2) poor design or methodology, (3) lack of publication, and (4) biased or inadequate reporting. This commentary, which was developed by a multidisciplinary group of researchers with spinal manipulative therapy (SMT) research expertise, discusses waste in SMT research and provides suggestions to improve future research. MAIN TEXT: This commentary examines common sources of waste in SMT research, focusing on design and methodological issues, by drawing on prior research and examples from clinical and mechanistic SMT studies. Clinical research is dominated by small studies and studies with a high risk of bias. This problem is compounded by systematic reviews that pool heterogenous data from varying populations, settings, and application of SMT. Research focusing on the mechanisms of SMT often fails to address the clinical relevance of mechanisms, relies on very short follow-up periods, and has inadequate control for contextual factors. CONCLUSIONS: This call to action is directed to researchers in the field of SMT. It is critical that the SMT research community act to improve the way research is designed, conducted, and disseminated. We present specific key action points and resources, which should enhance the quality and usefulness of future SMT research.

Care at a distance: Understanding lived experiences of people with MSK disorders receiving non-pharmacological interventions delivered through synchronous telehealth: A systematic rapid review.

Background: Little is known about lived experience of synchronous telehealth in patients with musculoskeletal (MSK) disorders. Objective: We conducted a rapid systematic review to answer: (1) what are the lived experiences and/or perspectives of people with MSK disorders receiving non-pharmacological interventions delivered through synchronous telehealth; and (2) what clinical implications can be inferred from qualitative studies focusing on lived experiences for how telehealth is delivered in the management of MSK disorders? Data sources: A comprehensive search of MEDLINE, CINAHL, PsycINFO, ProQuest, and Google Scholar from June 2010 to July 2023. Eligible qualitative and mixed methods studies capturing lived experiences of adults with MSK disorders receiving non-pharmacological interventions via synchronous telehealth were included. Study methods: Systematic rapid review conducted according to WHO guidelines. Titles and abstracts screened by reviewers independently, eligible studies critically appraised, and data was extracted. Themes summarized using the Consolidated Framework for Implementation Research (CFIR). GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) used to assess confidence in synthesis findings. Results: We identified 9782 references, screened 8029, and critically appraised 22, and included 17 studies. There is evidence to suggest that the experience of telehealth prior to and during the pandemic was shaped by (1) patient perception of telehealth, (2) existing relationships with practitioners, (3) availability and accessibility of telehealth technologies, and (4) perceptions about the importance of the role of the physical exam in assessing and treating MSK disorders. Conclusion: The five identified implications could be used to inform future research, policy, and strategy development.

Exercise therapy for treatment of acute non-specific low back pain: a Cochrane systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To assess the effectiveness of exercise for acute non-specific low back pain (LBP) versus our main comparisons: 1) sham treatment, and 2) no treatment at short-term (main follow-up time). DATA SOURCES AND STUDY SELECTION: A comprehensive search up till November 2021 was conducted in numerous databases for randomised controlled trials (RCTs) on the effectiveness of exercise in adults with acute LBP (< 6 weeks). Studies examining LBP with a specific aetiology were excluded. The primary outcomes were back pain, back-specific functional status and recovery. DATA EXTRACTION: Two review authors independently conducted the study selection, risk of bias assessment and data extraction. GRADE was used to assess the certainty of the evidence. DATA SYNTHESIS: We identified 23 RCTs (2674 participants). There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on pain (mean difference (MD) -0.80, 95% confidence interval (CI) -5.79 to 4.19; 1 study, 299 participants) and on functional status (MD 2.00, 95% CI -2.20 to 6.20; 1 study, 299 participants) in the short term. There is very low-quality evidence which suggests no difference in effect on pain and functional status for exercise vs. no treatment (2 studies; n=157, not pooled due to heterogeneity) at short-term follow-up. Similar results were found for the other follow-up moments. The certainty of the evidence was downgraded because many RCTs had a high risk of bias, were small in size and/or there was substantial heterogeneity. CONCLUSION: Exercise therapy compared to sham/placebo and no treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. Owing to insufficient reporting of adverse events, we were unable to reach any conclusions on the safety or harms related to exercise therapy.

Exercise therapy for treatment of acute non-specific low back pain.

BACKGROUND: Low back pain (LBP) is the leading cause of disability globally. It generates considerable direct costs (healthcare) and indirect costs (lost productivity). The many available treatments for LBP include exercise therapy, which is practised extensively worldwide. OBJECTIVES: To evaluate the benefits and harms of exercise therapy for acute non-specific low back pain in adults compared to sham/placebo treatment or no treatment at short-term, intermediate-term, and long-term follow-up. SEARCH METHODS: This is an update of a Cochrane Review first published in 2005. We conducted an updated search for randomised controlled trials (RCTs) in CENTRAL, MEDLINE, Embase, four other databases, and two trial registers. We screened the reference lists of all included studies and relevant systematic reviews published since 2004. SELECTION CRITERIA: We included RCTs that examined the effects of exercise therapy on non-specific LBP lasting six weeks or less in adults. Major outcomes for this review were pain, functional status, and perceived recovery. Minor outcomes were return to work, health-related quality of life, and adverse events. Our main comparisons were exercise therapy versus sham/placebo treatment and exercise therapy versus no treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. We evaluated outcomes at short-term follow-up (time point within three months and closest to six weeks after randomisation; main follow-up), intermediate-term follow-up (between nine months and closest to six months), and long-term follow-up (after nine months and closest to 12 months); and we used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included 23 studies (13 from the previous review, 10 new studies) that involved 2674 participants and provided data for 2637 participants. Three small studies are awaiting classification, and four eligible studies are ongoing. Included studies were conducted in Europe (N = 9), the Asia-Pacific region (N = 9), and North America (N = 5); and most took place in a primary care setting (N = 12), secondary care setting (N = 6), or both (N = 1). In most studies, the population was middle-aged and included men and women. We judged 10 studies (43%) at low risk of bias with regard to sequence generation and allocation concealment. Blinding is not feasible in exercise therapy, introducing performance and detection bias. There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on pain scores in the short term (mean difference (MD) -0.80, 95% confidence interval (CI) -5.79 to 4.19; 1 study, 299 participants). The absolute difference was 1% less pain (95% CI 4% more to 6% less), and the relative difference was 4% less pain (95% CI 20% more to 28% less). The mean pain score was 20.1 (standard deviation (SD) 21) for the intervention group and 20.9 (SD 23) for the control group. There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on functional status scores in the short term (MD 2.00, 95% CI -2.20 to 6.20; 1 study, 299 participants). The absolute difference was 2% worse functional status (95% CI 2% better to 6% worse), and the relative difference was 15% worse (95% CI 17% better to 47% worse). The mean functional status score was 15.3 (SD 19) for the intervention group and 13.3 (SD 18) for the control group. We downgraded the certainty of the evidence for pain and functional status by one level for risk of bias and by two levels for imprecision (only one study with fewer than 400 participants). There is very low-certainty evidence that exercise therapy compared with no treatment has no clinically relevant effect on pain or functional status in the short term (2 studies, 157 participants). We downgraded the certainty of the evidence by two levels for imprecision and by one level for inconsistency. One study associated exercise with small benefits and the other found no differences. The first study was conducted in an occupational healthcare centre, where participants received one exercise therapy session. The other study was conducted in secondary and tertiary care settings, where participants received treatment three times per week for six weeks. We did not pool data from these studies owing to considerable clinical heterogeneity. In two studies, there were no reported adverse events. One study reported adverse events unrelated to exercise therapy. The remaining studies did not report whether any adverse events had occurred. Owing to insufficient reporting of adverse events, we were unable to reach any conclusions on the safety or harms related to exercise therapy. AUTHORS' CONCLUSIONS: Exercise therapy compared to sham/placebo treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. Exercise therapy compared to no treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. We downgraded the certainty of the evidence to very low for inconsistency, risk of bias concerns, and imprecision (few participants).

Response to the Letter to the Editor-in-Chief.

Author response to the JOSPT Letter to the Editor-in-Chief "A Second Look at the Risks of Serious Adverse Events with Orthopaedic Manual Therapy, Paracetamol, and NSAID Treatment of Neck Pain" J Orthop Sports Phys Ther 2023;53(6):1-2. doi:10.2519/jospt.2023.0202-R.

The perceived barriers and facilitators for chiropractic care in older adults with low back pain; insights from a qualitative exploration in a dutch context.

BACKGROUND: Understanding care seeking behaviour is vital to enabling access to care. In the context of low back pain (LBP), chiropractors offer services to patients of all ages. Currently, geriatric sub-populations tend to be under-investigated, despite the disproportionate effects of LBP on older adults. In the Netherlands, the chiropractic profession is relatively unknown and therefore, generally speaking, is not considered as the first choice for conservative musculoskeletal primary health care. The aim of this paper was to explore the experiences of older adults with LBP, seeking chiropracic care for the first time, in order to identify perceived barriers and facilitators in this process. METHODS: Stage 1: Participants 56 years of age and older with chronic LBP who either sought or did not seek chiropractic care were interviewed to provide detailed information on the factors that promoted or impeded care-seeking behaviour. A purposive sampling strategy was used to recruit participants through a network of researchers, chiropractors and other healthcare professionals offering musculoskeletal health care services. Individuals with underlying pathology, previous surgery for LBP, or insufficient mastery of the Dutch language were excluded. Data were collected until saturation was reached and thematically analysed. Stage 2: To further explore the themes, a focus group interview was conducted with a provider stakeholder group consisting of:two physiotherapists, a nurse practitioner, a geriatrician, and a chiropractor. All interviews were conducted online, voice recorded, and transcribed verbatim. RESULTS: We interviewed 11 older adults with low back pain. During this process four themes emerged that captured their perception and experiences in either seeking or dismissing chiropractic care for their LBP; these being 'generic', 'financial', 'expectation', and 'the image of the chiropractor'. The focus group members largely confirmed the identified themes, highlighting a lack of awarenes and accessibility as key barriers to care. On the other hand, whe chiropractior as an alternative care provider, with a focus on manual interventions, was seen as a facilitator. CONCLUSIONS: The lack of knowledge about chiropractic care was found to be the most important barrier to seeking care. The most important facilitator was insufficient resolution of their symptoms following previous care, making patients look further for a solution for their problem. These barriers and facilitators seem not to differ greatly from barriers and facilitators found among younger patients with neck pain. Age and health condition may therefore be weak determinants of care. This new information may help us optimize accessibility for older adults to the chiropractor.

International Framework for Examination of the Cervical Region for Potential of Vascular Pathologies of the Neck Prior to Musculoskeletal Intervention: International IFOMPT Cervical Framework.

SYNOPSIS: This position statement, stemming from the International IFOMPT (International Federation of Orthopaedic Manipulative Physical Therapists) Cervical Framework, was developed based upon the best contemporary evidence and expert opinion to assist clinicians during their clinical reasoning process when considering presentations involving the head and neck. Developed through rigorous consensus methods, the International IFOMPT Cervical Framework guides assessment of the cervical spine region for potential vascular pathologies of the neck in advance of planned interventions. Within the cervical spine, events and presentations of vascular pathologies of the neck are rare but are an important consideration as part of patient examination. Vascular pathologies may be recognizable if the appropriate questions are asked during the patient history-taking process, if interpretation of elicited data enables recognition of this potential, and if the physical examination can be adapted to explore any potential vasculogenic hypothesis. J Orthop Sports Phys Ther 2023;53(1):7-22. Epub: 14 September 2022. doi:10.2519/jospt.2022.11147.

Management of people with low back pain: a survey of opinions and beliefs of Dutch and Belgian chiropractors.

BACKGROUND: Chiropractors commonly provide care to people with low-back pain (LBP). The aim of this survey was to determine the opinions and beliefs of chiropractors regarding the support and management of LBP. We also investigated whether their management is in accordance with the three most commonly recommended approaches to LBP based upon international guidelines (i.e. advice regarding return-to-work, limit bedrest, and stay active). METHODS: A web-based survey was sent out in 2013 to collect data from registered Dutch and Belgian chiropractors. In addition to providing a description of their sociodemographic and practice characteristics, chiropractors were asked to complete six patient vignettes representing people with LBP who typically present to a chiropractor. The respondents indicated which intervention(s) they would recommend or undertake. Based upon these vignettes, we were able to determine whether their management approach adhered to clinical guidelines. Generalized mixed models were used to explore guidelines adherence and their relationship to chiropractors' characteristics. RESULTS: In total, 60% (n = 203/340) of the chiropractors who were invited, chose to participate. Chiropractors reported applying a chiropractic adjustment in 90% of all vignettes, while the advice to exercise varied from one-third in the chronic cases to approximately half of those with acute LBP. More than 75% of the chiropractors would initially treat LBP 1-2 times a week. More than 90% of the chiropractors advised against bedrest. Overall, self-reported adherence to clinical guidelines for all six vignettes was [64.5% (CI 58.7-70.0)]. Adherence in the chronic vignettes [73.4% (CI 66.7-79.2)] was better than in the acute vignettes [55.9% (CI 50.5-61.1)]. Importantly, regarding recommended approaches to LBP, chiropractors more consistently followed guidelines regarding advice to limit bedrest [98.5% (CI 97.3-99.1)] than advice to stay active [77.5% (CI 72.3-81.9)] or return-to-work [59.4% (CI 55.2-63.4)]. Finally, Dutch chiropractors were more likely to adhere to the guidelines than Belgian chiropractors. CONCLUSIONS: Chiropractic adjustments were the most common self-reported treatment modalities supplemented by exercise in the management of LBP patients. Two-thirds of the chiropractors reported adhering to the guidelines regarding management and advice for LBP patients. Practitioners should improve guideline adherence, particularly for acute LBP cases, and when advising on return-to-work.

Does motor control training improve pain and function in adults with symptomatic lumbar disc herniation? A systematic review and meta-analysis of 861 subjects in 16 trials.

OBJECTIVE: To evaluate the effectiveness of motor control training (MCT) compared with other physical therapist-led interventions, minimal/no intervention or surgery in patients with symptomatic lumbar disc herniation (LDH). DESIGN: Systematic review and meta-analysis. DATA SOURCES: Eight databases and the ClinicalTrials.gov were searched from inception to April 2021. ELIGIBILITY CRITERIA: We included clinical trial studies with concurrent comparison groups which examined the effectiveness of MCT in patients with symptomatic LDH. Primary outcomes were pain intensity and functional status which were expressed as mean difference (MD) and standardised mean difference (SMD), respectively. RESULTS: We screened 6695 articles, of which 16 clinical trials (861 participants) were eligible. Fourteen studies were judged to have high risk of bias and two studies had some risk of bias. In patients who did not undergo surgery, MCT resulted in clinically meaningful pain reduction compared with other physical therapist-led interventions (ie, transcutaneous electrical nerve stimulation (TENS)) at short-term (MD -28.85, -40.04 to -17.66, n=69, studies=2). However, the robustness of the finding was poor. For functional status, a large and statistically significant treatment effect was found in favour of MCT compared with traditional/classic general exercises at long-term (SMD -0.83 to -1.35 to -0.31, n=63, studies=1) and other physical therapist-led interventions (ie, TENS) at short-term (SMD -1.43 to -2.41 to -0.46, n=69, studies=2). No studies compared MCT with surgery. In patients who had undergone surgery, large SMDs were seen. In favour of MCT compared with traditional/classic general exercises (SMD -0.95 to -1.32 to -0.58, n=124, studies=3), other physical therapist-led interventions (ie, conventional treatments; SMD -2.30 to -2.96 to -1.64, n=60, studies=1), and minimal intervention (SMD -1.34 to -1.87 to -0.81, n=68, studies=2) for functional improvement at short-term. The overall certainty of evidence was very low to low. CONCLUSION: At short-term, MCT improved pain and function compared with TENS in patients with symptomatic LDH who did not have surgery. MCT improved function compared with traditional/classic general exercises at long-term in patients who had undergone surgery. However, the results should be interpreted with caution because of the high risk of bias in the majority of studies. PROSPERO REGISTRATION NUMBER: CRD42016038166.

Diagnostic Imaging in Chiropractic Practice: A Survey of Opinions and Self-Reported Guideline Adherence of Dutch and Belgian Chiropractors.

OBJECTIVES: The purpose of this study was (1) to describe diagnostic imaging in Dutch and Belgian chiropractic practice in general, (2) to estimate adherence to the diagnostic imaging guidelines for patients with low back pain (LBP) via vignettes, and (3) to evaluate factors associated with diagnostic imaging and adherence to the guidelines. METHODS: We used a web-based survey to collect sociodemographic data, practice characteristics, amount of imaging, opinions, and indications for requesting imaging from registered Dutch and Belgian chiropractors in 2013. Additionally, adherence to imaging guidelines for LBP was assessed by 6 vignettes in patients with LBP. Multivariable regression analyses were conducted to explore associations between characteristics of chiropractors and the use of imaging. Generalized mixed models were used to explore guidelines adherence and their relationship with chiropractor's characteristics. RESULTS: The overall response rate was 60% (n = 203 out of 340). In total, 83% of chiropractors viewed diagnostic imaging in general as an important part of their practice. It is important to note that Dutch and Belgian chiropractors are not allowed to refer directly for imaging. Chiropractors reported that they would like to have imaging in 42% of their patients. Imaging had already been performed in 37% of patients before the first visit and was ordered by another health care provider (ie, general practitioner or medical specialist). The most common indication for ordering imaging was exclusion of contraindications (73%). The most common reason against imaging was the perceived limited value (45%). Many chiropractors (71%) were familiar with imaging guidelines. Adherence to the imaging guidelines for LBP based upon the vignettes was 66%. Dutch chiropractors and chiropractors with less than 10 years in practice demonstrated better adherence to guidelines and imaging use as compared with Belgian and those with more than 10 years of experience. CONCLUSIONS: Most Dutch and Belgian chiropractors reported that imaging in general was important in chiropractic practice. Self-reported indications for ordering diagnostic imaging were in line with the imaging guidelines in the majority of cases. We found some variances between Belgian and Dutch chiropractors and years of experience related to guideline adherence.

Spinal manipulative therapy in older adults with chronic low back pain: an individual participant data meta-analysis.

PURPOSE: Many systematic reviews have reported on the effectiveness of spinal manipulative therapy (SMT) for low back pain (LBP) in adults. Much less is known about the older population regarding the effects of SMT. OBJECTIVE: To assess the effects of SMT on pain and function in older adults with chronic LBP in an individual participant data (IPD) meta-analysis. SETTING: Electronic databases from 2000 until June 2020, and reference lists of eligible trials and related reviews. DESIGN AND SUBJECTS: Randomized controlled trials (RCTs) which examined the effects of SMT in adults with chronic LBP compared to interventions recommended in international LBP guidelines. METHODS: Authors of trials eligible for our IPD meta-analysis were contacted to share data. Two review authors conducted a risk of bias assessment. Primary results were examined in a one-stage mixed model, and a two-stage analysis was conducted in order to confirm findings. MAIN OUTCOMES AND MEASURES: Pain and functional status examined at 4, 13, 26, and 52 weeks. RESULTS: 10 studies were retrieved, including 786 individuals, of which 261 were between 65 and 91 years of age. There is moderate-quality evidence that SMT results in similar outcomes at 4 weeks (pain: mean difference [MD] - 2.56, 95% confidence interval [CI] - 5.78 to 0.66; functional status: standardized mean difference [SMD] - 0.18, 95% CI - 0.41 to 0.05). Second-stage and sensitivity analysis confirmed these findings. CONCLUSION: SMT provides similar outcomes to recommended interventions for pain and functional status in the older adult with chronic LBP. SMT should be considered a treatment for this patient population.

Roland-Morris Disability Questionnaire, Oswestry Disability Index, and Quebec Back Pain Disability Scale: Which Has Superior Measurement Properties in Older Adults With Low Back Pain?

OBJECTIVE: To examine the validity, reliability, and responsiveness of 3 commonly used questionnaires for assessing physical function (ie, Oswestry Disability Index [ODI], Quebec Back Pain Disability Scale [QBPDS], and Roland-Morris Disability Questionnaire [RMDQ]) in older patients undergoing chiropractic care for low back pain (LBP). DESIGN: Head-to-head clinimetric comparison. METHODS: Patients completed the ODI, QBPDS, and RMDQ at baseline and after 2 weeks of treatment. Reliability was evaluated for internal consistency (Cronbach α), test-retest reliability (interclass correlation coefficient [ICC]), and measurement error (standard error of measurement and smallest detectable change [SDC]). Structural validity was evaluated through unidimensional confirmatory factor analysis, and construct validity was investigated by a priori hypotheses with other measures. Responsiveness was evaluated by testing a priori hypotheses using data at baseline and at 2-week follow-up. RESULTS: Two hundred fourteen patients (53% males and 47% females) with a mean age of 66.2 years (standard deviation = 7.8 years) were included, of which 193 patients completed the 2-week follow-up for our responsiveness analysis. The RMDQ, ODI, and QBPDS showed sufficient internal consistency (Cronbach α of .89, .86, and .94, respectively) and test-retest reliability (ICC[2,1] of 0.85, 0.89, and 0.84, respectively). The SDC for the RMDQ was 6.9, for the ODI was 19.1, and for the QBPDS was 23.6, which are values larger than the minimal important change. None of the measures met all criteria for sufficient structural validity, but the RMDQ and ODI exhibited a partial unidimensional fit. The questionnaires had sufficient construct validity and responsiveness. CONCLUSION: The ODI, QBPDS, and RMDQ have similar measurement properties in older adults with LBP. J Orthop Sports Phys Ther 2022;52(7):457-469. Epub: 18 May 2022. doi:10.2519/jospt.2022.10802.

Full endoscopic versus open discectomy for sciatica: randomised controlled non-inferiority trial.

OBJECTIVE: To assess whether percutaneous transforaminal endoscopic discectomy (PTED) is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation. DESIGN: Multicentre randomised controlled trial with non-inferiority design. SETTING: Four hospitals in the Netherlands. PARTICIPANTS: 613 patients aged 18-70 years with at least six weeks of radiating leg pain caused by lumbar disc herniation. The trial included a predetermined set of 125 patients receiving PTED who were the learning curve cases performed by surgeons who did not do PTED before the trial. INTERVENTIONS: PTED (n=179) compared with open microdiscectomy (n=309). MAIN OUTCOME MEASURES: The primary outcome was self-reported leg pain measured by a 0-100 visual analogue scale at 12 months, assuming a non-inferiority margin of 5.0. Secondary outcomes included complications, reoperations, self-reported functional status as measured with the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery. Outcomes were measured until one year after surgery and were longitudinally analysed according to the intention-to-treat principle. Patients belonging to the PTED learning curve were omitted from the primary analyses. RESULTS: At 12 months, patients who were randomised to PTED had a statistically significantly lower visual analogue scale score for leg pain (median 7.0, interquartile range 1.0-30.0) compared with patients randomised to open microdiscectomy (16.0, 2.0-53.5) (between group difference of 7.1, 95% confidence interval 2.8 to 11.3). Blood loss was less, length of hospital admission was shorter, and timing of postoperative mobilisation was earlier in the PTED group than in the open microdiscectomy group. Secondary patient reported outcomes such as the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery, were similarly in favour of PTED. Within one year, nine (5%) in the PTED group compared with 14 (6%) in the open microdiscectomy group had repeated surgery. Per protocol analysis and sensitivity analyses including the patients of the learning curve resulted in similar outcomes to the primary analysis. CONCLUSIONS: PTED was non-inferior to open microdiscectomy in reduction of leg pain. PTED resulted in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery. These differences, however, were small and may not reach clinical relevance. PTED can be considered as an effective alternative to open microdiscectomy in treating sciatica. TRIAL REGISTRATION: NCT02602093ClinicalTrials.gov NCT02602093.

Cost-effectiveness of full endoscopic versus open discectomy for sciatica.

OBJECTIVE: To assess the costs and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) compared with open microdiscectomy among patients with sciatica. METHODS: This economic evaluation was conducted alongside a 12-month multicentre randomised controlled trial with a non-inferiority design, in which patients were randomised to PTED or open microdiscectomy. Patients were aged from 18 to 70 years and had at least 6 weeks of radiating leg pain caused by lumbar disc herniation. Effect measures included leg pain and quality-adjusted life years (QALYs), as derived using the EQ-5D-5L. Costs were measured from a societal perspective. Missing data were multiply imputed, bootstrapping was used to estimate statistical uncertainty, and various sensitivity analyses were conducted to determine the robustness. RESULTS: Of the 613 patients enrolled, 304 were randomised to PTED and 309 to open microdiscectomy. Statistically significant differences in leg pain and QALYs were found in favour of PTED at 12 months follow-up (leg pain: 6.9; 95% CI 1.3 to 12.6; QALYs: 0.040; 95% CI 0.007 to 0.074). Surgery costs were higher for PTED than for open microdiscectomy (ie, €4500/patient vs €4095/patient). All other disaggregate costs as well as total societal costs were lower for PTED than for open microdiscectomy. Cost-effectiveness acceptability curves indicated that the probability of PTED being less costly and more effective (ie, dominant) compared with open microdiscectomy was 99.4% for leg pain and 99.2% for QALYs. CONCLUSIONS: Our results suggest that PTED is more cost-effective from the societal perspective compared with open microdiscectomy for patients with sciatica. TRIAL REGISTRATION NUMBER: NCT02602093.

The effect of spinal manipulative therapy on pain relief and function in patients with chronic low back pain: an individual participant data meta-analysis.

BACKGROUND: A 2019 review concluded that spinal manipulative therapy (SMT) results in similar benefit compared to other interventions for chronic low back pain (LBP). Compared to traditional aggregate analyses individual participant data (IPD) meta-analyses allows for a more precise estimate of the treatment effect. PURPOSE: To assess the effect of SMT on pain and function for chronic LBP in a IPD meta-analysis. DATA SOURCES: Electronic databases from 2000 until April 2016, and reference lists of eligible trials and related reviews. STUDY SELECTION: Randomized controlled trials (RCT) examining the effect of SMT in adults with chronic LBP compared to any comparator. DATA EXTRACTION AND DATA SYNTHESIS: We contacted authors from eligible trials. Two review authors independently conducted the study selection and risk of bias. We used GRADE to assess the quality of the evidence. A one-stage mixed model analysis was conducted. Negative point estimates of the mean difference (MD) or standardized mean difference (SMD) favors SMT. RESULTS: Of the 42 RCTs fulfilling the inclusion criteria, we obtained IPD from 21 (n=4223). Most trials (s=12, n=2249) compared SMT to recommended interventions. There is moderate quality evidence that SMT vs recommended interventions resulted in similar outcomes on pain (MD -3.0, 95%CI: -6.9 to 0.9, 10 trials, 1922 participants) and functional status at one month (SMD: -0.2, 95% CI -0.4 to 0.0, 10 trials, 1939 participants). Effects at other follow-up measurements were similar. Results for other comparisons (SMT vs non-recommended interventions; SMT as adjuvant therapy; mobilization vs manipulation) showed similar findings. SMT vs sham SMT analysis was not performed, because we only had data from one study. Sensitivity analyses confirmed these findings. LIMITATIONS: Only 50% of the eligible trials were included. CONCLUSIONS: Sufficient evidence suggest that SMT provides similar outcomes to recommended interventions, for pain relief and improvement of functional status. SMT would appear to be a good option for the treatment of chronic LBP. Systematic Review Registration Number PROSPERO CRD42015025714.

Moderators of the Effect of Spinal Manipulative Therapy on Pain Relief and Function in Patients with Chronic Low Back Pain: An Individual Participant Data Meta-analysis.

STUDY DESIGN: Individual participant data (IPD) meta-analysis. OBJECTIVE: The aim of this study was to identify which participant characteristics moderate the effect of spinal manipulative therapy (SMT) on pain and functioning in chronic LBP. SUMMARY OF BACKGROUND: The effects of SMT are comparable to other interventions recommended in guidelines for chronic low back pain (LBP); however, it is unclear which patients are more likely to benefit from SMT compared to other therapies. METHODS: IPD were requested from randomized controlled trials (RCTs) examining the effect of SMT in adults with chronic LBP for pain and function compared to various other therapies (stratified by comparison). Potential patient moderators (n = 23) were a priori based on their clinical relevance. We investigated each moderator using a one-stage approach with IPD and investigated this interaction with the intervention for each time point (1, 3, 6, and 12 months). RESULTS: We received IPD from 21 of 46 RCTs (n = 4223). The majority (12 RCTs, n = 2249) compared SMT to recommended interventions. The duration of LBP, baseline pain (confirmatory), smoking, and previous exposure to SMT (exploratory) had a small moderating effect across outcomes and follow-up points; these estimates did not represent minimally relevant differences in effects; for example, patients with <1 year of LBP demonstrated more positive point estimates for SMT versus recommended therapy for the outcome pain (mean differences ranged from 4.97 (95% confidence interval, CI: -3.20 to 13.13) at 3 months, 10.76 (95% CI: 1.06 to 20.47) at 6 months to 5.26 (95% CI: -2.92 to 13.44) at 12 months in patients with over a year LBP. No other moderators demonstrated a consistent pattern across time and outcomes. Few moderator analyses were conducted for the other comparisons because of too few data. CONCLUSION: We did not identify any moderators that enable clinicians to identify which patients are likely to benefit more from SMT compared to other treatments.Level of Evidence: 2.

Percutaneous Transforaminal Endoscopic Discectomy Versus Open Microdiscectomy for Lumbar Disc Herniation: A Systematic Review and Meta-analysis.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVE: To give a systematic overview of effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) compared with open microdiscectomy (OM) in the treatment of lumbar disk herniation (LDH). SUMMARY OF BACKGROUND DATA: The current standard procedure for the treatment of sciatica caused by LDH, is OM. PTED is an alternative surgical technique which is thought to be less invasive. It is unclear if PTED has comparable outcomes compared with OM. METHODS: Multiple online databases were systematically searched up to April 2020 for randomized controlled trials and prospective studies comparing PTED with OM for LDH. Primary outcomes were leg pain and functional status. Pooled effect estimates were calculated for the primary outcomes only and presented as standard mean differences (SMD) with their 95% confidence intervals (CI) at short (1-day postoperative), intermediate (3-6 months), and long-term (12 months). RESULTS: We identified 2276 citations, of which eventually 14 studies were included. There was substantial heterogeneity in effects on leg pain at short term. There is moderate quality evidence suggesting no difference in leg pain at intermediate (SMD 0.05, 95% CI -0.10-0.21) and long-term follow-up (SMD 0.11, 95% CI -0.30-0.53). Only one study measured functional status at short-term and reported no differences. There is moderate quality evidence suggesting no difference in functional status at intermediate (SMD -0.09, 95% CI -0.24-0.07) and long-term (SMD -0.11, 95% CI -0.45-0.24). CONCLUSION: There is moderate quality evidence suggesting no difference in leg pain or functional status at intermediate and long-term follow-up between PTED and OM in the treatment of LDH. High quality, robust studies reporting on clinical outcomes and cost-effectiveness on the long term are lacking.Level of Evidence: 2.

Predictors of low back disability in chiropractic and physical therapy settings.

BACKGROUND: Predicting ongoing disability for chronic non-specific low back pain (LBP) is important to avoid prolonged disability. OBJECTIVE: Determine predictors of disability at 6 month follow-up in patients with LBP at medium risk of ongoing disability. METHODS: Baseline data was collected from 108 patients with medium-risk chronic non-specific LBP (mean age 50.4 years, SD 13.6) from six private chiropractic and physiotherapy clinics in Australia who took part in a randomised control trial. All patients received a pragmatic course of multimodal physical treatments [e.g., manual therapy (spinal manipulation or mobilization and/or soft tissue massage)] combined with advice, education and exercise. Baseline prognostic variables included sociodemographic, physical and psychological characteristics. Primary outcome was disability (Roland Morris Disability) at 6 month follow-up. Multivariable linear regression analysis was conducted. RESULTS: Variables remaining in the final multivariable model: lower work ability (ß = - 1.05, 95% CI - 1.40 to - 0.70; p < 0.0001) and consultation with a medical specialist for back pain in the preceding 3 months (ß = 3.35, 95% CI 1.14 to 5.55; p < 0.003), which significantly predicted higher disability at 6 months (unadjusted R 2 = 0.31). Those with a lower work ability (scale 1 to 10) and who had seen a medical specialist for their back pain were more likely to report greater LBP-related disability at 6 months. CONCLUSION: Patients with chronic LBP presenting to primary care with lower work ability and recent consultation with a medical specialist for LBP are more likely to have a worse prognosis; these are indicators to clinicians that standard conservative care may not adequately manage the patients' needs.

Is reduction of routine radiograph use in patients with distal radius fractures cost effective? Analysis of data from the multicentre, randomised controlled WARRIOR trial.

OBJECTIVE: To assess the cost effectiveness of a reduced imaging follow-up protocol of distal radius fractures compared with usual care. DESIGN: An economical evaluation conducted alongside a multicentre randomised controlled trial (RCT). SETTING: Four level-one trauma centres in the Netherlands. PARTICIPANTS: 341 patients participated (usual care (n=172), reduced imaging (n=169)). INTERVENTIONS: Patients were randomised to usual care (routine radiography at 1, 2, 6 and 12 weeks) or a reduced imaging strategy (radiographs at 6 and 12 weeks only for a clinical indication). OUTCOME MEASURES: Functional outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and quality-adjusted life years (QALYs) using the EuroQol-5Dimensions-3 Levels (EQ-5D-3L). Costs were measured using self-reported questionnaires and medical records, and analysed from a societal perspective. Multiple imputation, seemingly unrelated regression analysis and bootstrapping were used to analyse the data. RESULTS: Clinical overall outcomes of both groups were comparable. The difference in DASH was -2.03 (95% CI -4.83 to 0.77) and the difference in QALYs was 0.025 (95% CI -0.01 to 0.06). Patients in the reduced imaging group received on average 3.3 radiographs (SD: 1.9) compared with 4.2 (SD: 1.9) in the usual care group. Costs for radiographic imaging were significantly lower in the reduced imaging group than in the usual care group (€-48 per patient, 95% CI -68 to -27). There was no difference in total costs between groups (€-401 per patient, 95% CI -2453 to 1251). The incremental cost-effectiveness ratio (ICER) for QALYs was -15 872; the ICER for the DASH was 198. The probability of reduced imaging being cost effective compared with usual care ranged from 0.8 to 0.9 at a willingness to pay of €20 000/QALY to €80 000/QALY. CONCLUSIONS: Implementing a reduced imaging strategy in the follow-up of distal radius fractures has a high probability of being cost effective for QALYs, without decreasing functional outcome. We, therefore, recommend imaging only when clinically indicated. TRIAL REGISTRATION NUMBER: The Netherlands trial register (NL4477).