Exercise Therapy for Treatment of Acute Non-specific Low Back Pain: A Cochrane Systematic Review and Meta-analysis of Randomized Controlled Trials.

OBJECTIVE: To assess the effectiveness of exercise for acute non-specific low back pain (LBP) vs 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 randomized controlled trials on the effectiveness of exercise in adults with acute LBP (<6 weeks). Studies examining LBP with a specific etiology 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 randomized controlled trials (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 randomized controlled trials had a high risk of bias, were small in size, and/or there was substantial heterogeneity. CONCLUSION: Exercise therapy compared with 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).

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.

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.

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.

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.

Routine Follow-Up Radiographs for Ankle Fractures Seldom Add Value to Clinical Decision-Making: A Retrospective, Observational Study.

Currently, the routine use of radiographs for uncomplicated ankle fractures represents good clinical practice. However, radiographs are associated with waiting time, radiation exposure, and costs. Studies have suggested that radiographs seldom alter the treatment strategy if no clinical indication for the imaging study was present. The objective of the present study was to evaluate the effect of routine radiographs on the treatment strategy during the follow-up period of ankle fractures. All patients aged ≥18 years, who had visited 1 of the participating clinics with an eligible ankle fracture in 2012 and with complete follow-up data were included. The data were retrospectively analyzed. The sociodemographic and clinical characteristics and the number of, and indications for, the radiographs taken were collected from the medical records of the participating clinics. We assessed the changes in treatment strategy according to the radiographic findings. In 528 patients with an ankle fracture, 1174 radiographs were performed during the follow-up period. Of these radiographs, 936 (79.7%) were considered routine. Of the routine radiographs taken during the follow-up period, only 11 (1.2 %) resulted in changes to the treatment strategy. Although it is common practice to take radiographs routinely during the follow-up period for ankle fractures, the results from the present study suggest that routine radiographs seldom alter the treatment strategy. This limited clinical relevance should be weighed against the health care costs and radiation exposure associated with the use of routine radiographs. For a definitive recommendation, however, the results of our study should be confirmed by a prospective trial, which we are currently conducting.

Guideline for Reporting Interventions on Spinal Manipulative Therapy: Consensus on Interventions Reporting Criteria List for Spinal Manipulative Therapy (CIRCLe SMT).

OBJECTIVE: The aim of the Consensus on Interventions Reporting Criteria List for Spinal Manipulative Therapy (CIRCLe SMT) study was to develop a criteria list for reporting spinal manipulative therapy (SMT). METHODS: A Delphi procedure was conducted from September 2011 to April 2013 and consisted of international experts in the field of SMT. The authors formed a steering committee and invited participants, selected initial items, structured the comments of the participants after each Delphi round, and formulated the feedback. To ensure content validity, a large number of international experts from different SMT-related disciplines were invited to participate. A workshop was organized following the consensus phase, and it was used to discuss and refine the wording of the items. RESULTS: In total, 123 experts from 18 countries participated. These experts included clinicians (70%), researchers (93%), and academics working in the area of SMT (27%), as well as journal editors (14%). (Note: The total is more than 100% because most participants reported 2 jobs.) Three Delphi rounds were necessary to reach a consensus. The criteria list comprised 24 items under 5 domains, including (1) rationale of the therapy, (2) description of the intervention, (3) SMT techniques, (4) additional intervention/techniques, and (5) quantitative data. CONCLUSIONS: A valid criteria list was constructed with the aim of promoting consistency in reporting SMT intervention in scientific publications.

Trocar types in laparoscopy.

BACKGROUND: Laparoscopic surgery has led to great clinical improvements in many fields of surgery; however, it requires the use of trocars, which may lead to complications as well as postoperative pain. The complications include intra-abdominal vascular and visceral injury, trocar site bleeding, herniation and infection. Many of these are extremely rare, such as vascular and visceral injury, but may be life-threatening; therefore, it is important to determine how these types of complications may be prevented. It is hypothesised that trocar-related complications and pain may be attributable to certain types of trocars. This systematic review was designed to improve patient safety by determining which, if any, specific trocar types are less likely to result in complications and postoperative pain. OBJECTIVES: To analyse the rates of trocar-related complications and postoperative pain for different trocar types used in people undergoing laparoscopy, regardless of the condition. SEARCH METHODS: Two experienced librarians conducted a comprehensive search for randomised controlled trials (RCTs) in the Menstrual Disorders and Subfertility Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, CINAHL, CDSR and DARE (up to 26 May 2015). We checked trial registers and reference lists from trial and review articles, and approached content experts. SELECTION CRITERIA: RCTs that compared rates of trocar-related complications and postoperative pain for different trocar types used in people undergoing laparoscopy. The primary outcomes were major trocar-related complications, such as mortality, conversion due to any trocar-related adverse event, visceral injury, vascular injury and other injuries that required intensive care unit (ICU) management or a subsequent surgical, endoscopic or radiological intervention. Secondary outcomes were minor trocar-related complications and postoperative pain. We excluded trials that studied non-conventional laparoscopic incisions. DATA COLLECTION AND ANALYSIS: Two review authors independently conducted the study selection, risk of bias assessment and data extraction. We used GRADE to assess the overall quality of the evidence. We performed sensitivity analyses and investigation of heterogeneity, where possible. MAIN RESULTS: We included seven RCTs (654 participants). One RCT studied four different trocar types, while the remaining six RCTs studied two different types. The following trocar types were examined: radially expanding versus cutting (six studies; 604 participants), conical blunt-tipped versus cutting (two studies; 72 participants), radially expanding versus conical blunt-tipped (one study; 28 participants) and single-bladed versus pyramidal-bladed (one study; 28 participants). The evidence was very low quality: limitations were insufficient power, very serious imprecision and incomplete outcome data. Primary outcomesFour of the included studies reported on visceral and vascular injury (571 participants), which are two of our primary outcomes. These RCTs examined 473 participants where radially expanding versus cutting trocars were used. We found no evidence of a difference in the incidence of visceral (Peto odds ratio (OR) 0.95, 95% confidence interval (CI) 0.06 to 15.32) and vascular injury (Peto OR 0.14, 95% CI 0.0 to 7.16), both very low quality evidence. However, the incidence of these types of injuries were extremely low (i.e. two cases of visceral and one case of vascular injury for all of the included studies). There were no cases of either visceral or vascular injury for any of the other trocar type comparisons. No studies reported on any other primary outcomes, such as mortality, conversion to laparotomy, intensive care admission or any re-intervention. Secondary outcomesFor trocar site bleeding, the use of radially expanding trocars was associated with a lower risk of trocar site bleeding compared to cutting trocars (Peto OR 0.28, 95% CI 0.14 to 0.54, five studies, 553 participants, very low quality evidence). This suggests that if the risk of trocar site bleeding with the use of cutting trocars is assumed to be 11.5%, the risk with the use of radially expanding trocars would be 3.5%. There was insufficient evidence to reach a conclusion regarding other trocar types, their related complications and postoperative pain, as no studies reported data suitable for analysis. AUTHORS' CONCLUSIONS: Data were lacking on the incidence of major trocar-related complications, such as visceral or vascular injury, when comparing different trocar types with one another. However, caution is urged when interpreting these results because the incidence of serious complications following the use of a trocar was extremely low. There was very low quality evidence for minor trocar-related complications suggesting that the use of radially expanding trocars compared to cutting trocars leads to reduced incidence of trocar site bleeding. These secondary outcomes are viewed to be of less clinical importance.Large, well-conducted observational studies are necessary to answer the questions addressed in this review because serious complications, such as visceral or vascular injury, are extremely rare. However, for other outcomes, such as trocar site herniation, bleeding or infection, large observational studies may be needed as well. In order to answer these questions, it is advisable to establish an international network for recording these types of complications following laparoscopic surgery.

Serious Adverse Events and Spinal Manipulative Therapy of the Low Back Region: A Systematic Review of Cases.

OBJECTIVE: The purpose of this study was to systematically search the literature for studies reporting serious adverse events following lumbopelvic spinal manipulative therapy (SMT) and to describe the case details. METHODS: A systematic search was conducted in PubMed including MEDLINE, EMBASE, CINAHL, and The Cochrane Library up to January 12, 2012, by an experienced reference librarian. Study selection was performed by 2 independent reviewers using predefined criteria. We included cases involving individuals 18 years or older who experienced a serious adverse event following SMT applied to the lumbar spine or pelvis by any type of provider (eg, chiropractic, medical, physical therapy, osteopathic, layperson). A serious adverse event was defined as an untoward occurrence that results in death or is life threatening, requires hospital admission, or results in significant or permanent disability. We included studies published in English, German, Dutch, and Swedish. RESULTS: A total of 2046 studies were screened, and 41 studies reporting on 77 cases were included. Important case details were frequently unreported, such as descriptions of SMT technique, the pre-SMT presentation of the patient, the specific details of the adverse event, time from SMT to the adverse event, factors contributing to the adverse event, and clinical outcome. Adverse events consisted of cauda equina syndrome (29 cases, 38% of total); lumbar disk herniation (23 cases, 30%); fracture (7 cases, 9%); hematoma or hemorrhagic cyst (6 cases, 8%); or other serious adverse events (12 cases, 16%) such as neurologic or vascular compromise, soft tissue trauma, muscle abscess formation, disrupted fracture healing, and esophageal rupture. CONCLUSIONS: This systematic review describes case details from published articles that describe serious adverse events that have been reported to occur following SMT of the lumbopelvic region. The anecdotal nature of these cases does not allow for causal inferences between SMT and the events identified in this review. Recommendations regarding future case reporting and research aimed at furthering the understanding of the safety profile of SMT are discussed.

Minimally invasive surgery for lumbar disc herniation: a systematic review and meta-analysis.

PURPOSE: Assessing the benefits of surgical treatments for sciatica is critical for clinical and policy decision-making. To compare minimally invasive (MI) and conventional microdiscectomy (MD) for patients with sciatica due to lumbar disc herniation. METHODS: A systematic review and meta-analysis of controlled clinical trials including patients with sciatica due to lumbar disc herniation. Conventional microdiscectomy was compared separately with: (1) Interlaminar MI discectomy (ILMI vs. MD); (2) Transforaminal MI discectomy (TFMI vs. MD). OUTCOMES: Back pain, leg pain, function, improvement, work status, operative time, blood loss, length of hospital stay, complications, reoperations, analgesics and cost outcomes were extracted and risk of bias assessed. Pooled effect estimates were calculated using random effect meta-analysis. RESULTS: Twenty-nine studies, 16 RCTs and 13 non-randomised studies (n = 4,472), were included. Clinical outcomes were not different between the surgery types. There is low quality evidence that ILMI takes 11 min longer, results in 52 ml less blood loss and reduces mean length of hospital stay by 1.5 days. There were no differences in complications or reoperations. The main limitations were high risk of bias, low number of studies and small sample sizes comparing TF with MD. CONCLUSIONS: There is moderate to low quality evidence of no differences in clinical outcomes between MI surgery and conventional microdiscectomy for patients with sciatica due to lumbar disc herniation. Studies comparing transforaminal MI with conventional surgery with sufficient sample size and methodological robustness are lacking.

The risk of bias and sample size of trials of spinal manipulative therapy for low back and neck pain: analysis and recommendations.

OBJECTIVE: The purpose of this study was to evaluate changes in methodological quality and sample size in randomized controlled trials (RCTs) of spinal manipulative therapy (SMT) for neck and low back pain over a specified period. A secondary purpose was to make recommendations for improvement for future SMT trials based upon our findings. METHODS: Randomized controlled trials that examined the effect of SMT in adults with neck and/or low back pain and reported at least 1 patient-reported outcome measure were included. Studies were identified from recent Cochrane reviews of SMT, and an update of the literature was conducted (March 2013). Risk of bias was assessed using the 12-item criteria recommended by the Cochrane Back Review Group. In addition, sample size was examined. The relationship between the overall risk of bias and sample size over time was evaluated using regression analyses, and RCTs were grouped into periods (epochs) of approximately 5 years. RESULTS: In total, 105 RCTs were included, of which 41 (39%) were considered to have a low risk of bias. There is significant improvement in the mean risk of bias over time (P < .05), which is the most profound for items related to selection bias and, to a lesser extent, attrition and selective outcome reporting bias. Furthermore, although there is no significant increase in sample size over time (overall P = .8), the proportion of studies that performed an a priori sample size calculation is increasing statistically (odds ratio, 2.1; confidence interval, 1.5-3.0). Sensitivity analyses suggest no appreciable difference between studies for neck or low back pain for risk of bias or sample size. CONCLUSION: Methodological quality of RCTs of SMT for neck and low back pain is improving, whereas overall sample size has shown only small and nonsignificant increases. There is an increasing trend among studies to conduct sample size calculations, which relate to statistical power. Based upon these findings, 7 areas of improvement for future SMT trials are suggested.

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.

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.

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.

Surgery versus conservative care for neck pain: a systematic review.

OBJECTIVE: General practitioners refer patients with continued neck pain that do not respond well to conservative care frequently to secondary care for further assessment. Are surgical interventions to the cervical spine effective when compared to conservative care for patients with neck pain? DESIGN: Systematic review. METHOD: The search strategy outlined by the Cochrane Back Review Group (CBRG) was followed. The primary search was conducted in MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro up to June 2011. Randomised controlled trials (RCTs) and controlled clinical trials (CCTs) of adults with neck pain, which evaluated at least one clinically relevant primary outcome measure (e.g. pain, functional status, recovery), were included. In addition, treatments had to include surgery and conservative care. Two authors independently assessed risk of bias using the criteria recommended by the CBRG and extracted the data. The quality of the evidence was rated using the GRADE method. RESULTS: Patients included had neck pain with or without radiculopathy or myelopathy. In total, three RCTs and six CCTs were identified comparing different surgical interventions with conservative care, of which one had a low risk of bias. Overall there is very low quality of evidence available on the effectiveness of surgery compared to conservative care in neck pain patients showing overall no differences. CONCLUSION: Most studies on surgical techniques comparing these to conservative care showed a high risk of bias. The benefit of surgery over conservative care is not clearly demonstrated.

The evidence on surgical interventions for low back disorders, an overview of systematic reviews.

PURPOSE: Many systematic reviews have been published on surgical interventions for low back disorders. The objective of this overview was to evaluate the available evidence from systematic reviews on the effectiveness of surgical interventions for disc herniation, spondylolisthesis, stenosis, and degenerative disc disease (DDD). An earlier version of this review was published in 2006 and since then, many new, better quality reviews have been published. METHODS: A comprehensive search was performed in the Cochrane database of systematic reviews (CDSR), database of reviews of effectiveness (DARE) and Pubmed. Two reviewers independently performed the selection of studies, risk of bias assessment, and data extraction. Included are Cochrane reviews and non-Cochrane systematic reviews published in peer-reviewed journals. The following conditions were included: disc herniation, spondylolisthesis, and DDD with or without spinal stenosis. The following comparisons were evaluated: (1) surgery vs. conservative care, and (2) different surgical techniques compared to one another. The methodological quality of the systematic reviews was evaluated using AMSTAR. We report (pooled) analyses from the individual reviews. RESULTS: Thirteen systematic reviews on surgical interventions for low back disorders were included for disc herniation (n = 6), spondylolisthesis (n = 2), spinal stenosis (n = 4), and DDD (n = 4). Nine (69 %) were of high quality. Five reviews provided a meta-analysis of which two showed a significant difference. For the treatment of spinal stenosis, intervertebral process devices showed more favorable results compared to conservative treatment on the Zurich Claudication Questionnaire [mean difference (MD) 23.2 95 % CI 18.5-27.8]. For degenerative spondylolisthesis, fusion showed more favorable results compared to decompression for a mixed aggregation of clinical outcome measures (RR 1.40 95 % CI 1.04-1.89) and fusion rate favored instrumented fusion over non-instrumented fusion (RR 1.37 95 % CI 1.07-1.75). CONCLUSIONS: For most of the comparisons, the included reviews were not significant and/or clinically relevant differences between interventions were identified. Although the quality of the reviews was quite acceptable, the quality of the included studies was poor. Future studies are likely to influence our assessment of these interventions.

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.

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.