Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies: the CoPPS Statement
Control interventions (often called “sham,” “placebo,” or “attention controls”) are essential for studying the efficacy or mechanism of physical, psychological, and self-management interventions in clinical trials. This article presents core recommendations for designing, conducting, and reporting control interventions to establish a quality standard in non-pharmacological intervention research. A framework of additional considerations supports researchers’ decision making in this context. We also provide a reporting checklist for control interventions to enhance research transparency, usefulness, and rigour.
Randomized Trials vs Real-world Evidence How Can Both Inform Decision-making?
Noting that randomized clinical trials (RCTs) “generally yield the strongest inferences about the effects of medical treatments,”1(p984) the AMA Manual of Style instructs that “randomized trials may use terms such as effectand causal relationship,”1(p983) In contrast, the manual claims that observational studies “cannot lead to causal inferences”1(p994) and thus “should be described in terms of association or correlation and should avoid cause-and-effect wording.”1(p983) Nevertheless, analyses of observational data—often consisting of real-world evidence from databases of medical claims and electronic health records—play an increasingly prominent role in health care. Given the well-recognized limitations of observational studies, their growing use to estimate treatment effects is the subject of considerable controversy. Should real-world evidence have a meaningful role in decision-making? In this issue of JAMA, investigators from the RCT DUPLICATE Initiative2 address this controversy by directly comparing the results of published RCTs to analyses of 3 national claims databases that are carefully designed to emulate the original RCTs. The results of their productive line of research warrant careful consideration.
Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article I): a systematic review and description of methods
Blinding is challenging in randomised controlled trials of physical, psychological, and self-management therapies for pain, mainly because of their complex and participatory nature. To develop standards for the design, implementation, and reporting of control interventions in efficacy and mechanistic trials, a systematic overview of currently used sham interventions and other blinding methods was required.
A Randomized Controlled Trial of Osteopathic Manipulative Therapy to Reduce Cranial Asymmetries in Young Infants with Nonsynostotic Plagiocephaly
This study aimed to compare the efficacy of osteopathic manipulative therapy (OMTh) versus light touch therapy (LTT) in reducing cranial asymmetries in infants with nonsynostotic plagiocephaly (NSP).
Avoiding nocebo and other undesirable effects in chiropractic, osteopathy and physiotherapy: An invitation to reflect
While the placebo effect is increasingly recognised as a contributor to treatment effects in clinical practice, the nocebo and other undesirable effects are less well explored and likely underestimated. In the chiropractic, osteopathy and physiotherapy professions, some aspects of historical models of care may arguably increase the risk of nocebo effects.
Manual therapy prevents onset of nociceptor activity, sensorimotor dysfunction, and neural fibrosis induced by a volitional repetitive task.
Painful and disabling musculoskeletal disorders remain prevalent. In rats trained to perform repetitive tasks leading to signs and dysfunction similar to those in humans, we tested whether manual therapy would prevent the development of the pathologies and symptoms. We collected behavioral, electrophysiological, and histological data from control rats, rats that trained for 5 weeks before performing a high-repetition high-force (HRHF) task for 3 weeks untreated, and trained rats that performed the task for 3 weeks while being treated 3x/week using modeled manual therapy (MMT) to the forearm (HRHF + MMT). (...)
We conclude that the performance of the task for 3 weeks leads to increased ongoing activity in nociceptors, in parallel with behavioral and histological signs of neuritis and nerve injury, and that these pathophysiologies are largely prevented by MMT.
Effect of osteopathic techniques on human resting muscle tone in healthy subjects using myotonometry: a factorial randomized trial
Musculoskeletal disorders (MSDs) are highly prevalent, burdensome, and putatively associated with an altered human resting muscle tone (HRMT). Osteopathic manipulative treatment (OMT) is commonly and effectively applied to treat MSDs and reputedly influences the HRMT. Arguably, OMT may modulate alterations in HRMT underlying MSDs. However, there is sparse evidence even for the effect of OMT on HRMT in healthy subjects. A 3 × 3 factorial randomised trial was performed to investigate the effect of myofascial release (MRT), muscle energy (MET), and soft tissue techniques (STT) on the HRMT of the corrugator supercilii (CS), superficial masseter (SM), and upper trapezius muscles (UT) in healthy subjects in Hamburg, Germany.
4 M’s to make sense of evidence – Avoiding the propagation of mistakes, misinterpretation, misrepresentation and misinformation
This Masterclass helps osteopaths to make sense of research.
It helps osteopaths decide how/when to apply research findings in their clinical practice.
A simple framework to assess the literature is provided.
Case reports, clinical trials, qualitative research, and reviews are detailed specifically.
Quantitative investigation of ligament strains during physical tests for sacroiliac joint pain using finite element analysis.
In this study, a three-dimensional finite element model of the sacroiliac joint was developed and the biomechanical conditions for six typical physical tests such as the compression test, distraction test, sacral apex pressure test, thigh thrust test, Patrick's test, and Gaenslen's test were modelled.
Blinding, Sham and Treatment Effects in Randomized Controlled Trials for Back Pain in 2000–2019: A Review and Meta-analytic Approach
Blinding aims to minimize biases from what participants and investigators know or believe. Randomized controlled trials, despite being the gold standard to evaluate treatment effect, do not generally assess the success of blinding. We investigated the extent of blinding in back pain trials and the associations between participant guesses and treatment effects.