Background:
Musculoskeletal (MSK) ill-health is the greatest socioeconomic burden for the World’s healthcare systems to manage. Established in ancient history, manual therapy uses a hands-on approach (hereon in referred to as HODA-A, hands-on data acquisition and analysis) provides a safe, affordable, and environmentally convenient assessment and treatment of a person’s MSK system. HODA-A is used to palpate characteristics of a person’s anatomy, becoming the measurement instrument that underpins the majority of MSK investigations conducted by MSK professionals in both MSK medicine (theory, research, and practice) and MSK clinical practice, often a prerequisite that informs a person’s care in many healthcare disciplines.

Purpose:
The existing evidence-based research investigating HODA-A, or studies that have used HODA-A as part of the methodology, are flawed because HODA-A lacks the necessary developmental studies to determine its validity as a measurement instrument. For more than 70 years the evidence-based research has focused on reliability studies of HODA-A, concluding it is clinically unacceptable as a measurement instrument - further fuelling the hands-on/hands-off debate. However, according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias (RoB) standards, validity studies must precede reliability studies on all proposed measurement instruments. Therefore, to conduct reliability studies without the necessary ‘first-step’ validity studies on HODA-A constitutes a methodological flaw, is a waste of resources and unethical. Worryingly, within the next 10 years, it is predicted an estimated 250 papers per annum will be published on HODA-A with the same fatal methodological flaws.

Methods:
Initially, a literature review exploring centuries of neurophysiological research, studying how to replicate the human hand for prosthesis and robotics sciences, provided strong evidence detailing five phases that occur when a person is tasked to interpret their active touch. This information supported a later phenomenographic study using sixteen international expert panellists to explore the Scientific Evaluation and Review of Claims in Health Care (SEaRCH™) of HODA-A when used as a measurement instrument in MSK healthcare. The information gained from these extensive studies was evaluated using the COSMIN RoB standards.

Results:
HODA-A uses eight constructs with associated items to conduct manual MSK assessments on a person, and HODA-A requires a complex system approach to understanding the relationships between the eight constructs and items underpinning HODA-A performance.

Conclusion(s):
For the first time in history HODA-A has been exposed to validity testing, offering substantial insights into the necessary measurement theories and conceptual framework needed for HODA-A to be used as a valid measurement instrument in MSK healthcare. Further research exposing HODA-A to COSMIN RoB standards continued.

Implications:
Reliability studies on HODA-A should only be conducted if the methodology of how HODA-A was applied met all the COSMIN RoB standards.

Background:
Spinal conditions are prevalent causes of pain and disability worldwide. Gaining insight into the comparative effectiveness of manual therapy interventions with alternative treatments can enlighten patients and healthcare professionals regarding the most suitable methods for effectively managing these conditions.

Purpose:
The purpose of this umbrella review was to summarize, synthesize, and integrate the evidence evaluating the effectiveness of manual therapy intervention(s) with other interventions for the treatment of different spinal conditions.

Methods:
This is an umbrella review of systematic reviews. We have searched seven databases (CINAHL, Cochrane, EMBASE, Epistemonikos, Medline (PubMed), SCOPUS, and Web of Science) and obtained systematic reviews that compare spinal manual therapy alone (mobilization, manipulation, and manual traction) with control, no treatment, or sham treatment. A pair of reviewers assessed the quality of the systematic reviews using A Measurement Tool to Assess Systematic Reviews (AMSTAR 2) tool. We extracted data related to study characteristics and the effectiveness of spinal manual therapy, categorizing by treatment technique, outcome measures, and condition. The corrected covered area (CCA) index had been calculated to identify duplicating randomized controlled trials.

Results:
A total of 3,918 citations were identified. We screened in 2,146 citations after removing duplication. 179 articles were reviewed in full text screening phase. In total, 21 systematic reviews met our eligibility criteria. The quality of the included systematic reviews was rated mainly as critically low (n = 14) or low (n = 6), while only one study was of high quality. Although manipulation may provide short-term relief for acute and chronic low back pain, its impact on functional improvement is uncertain. Similarly, the short-term effects of manipulation on pain levels in acute and chronic neck pain remain uncertain. Limited evidence exists comparing mobilization alone to other interventions, and the effects of manipulation and mobilization on pain and function are inconsistent. The CCA index was 3.97%, indicating a low overlapping of the included reviews.

Conclusion(s):
Due to the low-quality nature of the systematic reviews and meta-analyses included in this study, the findings should be interpreted with caution. No definitive recommendation can be made for the effectiveness of spinal manual therapy. Higher-quality systematic reviews and randomized controlled trials are needed to further support the use of spinal manual therapy in spinal pain conditions.

Implications:
These findings emphasize the need for caution in interpreting the effectiveness of spinal manual therapy due to the low-quality evidence available. As such, healthcare professionals should approach the use of manual therapy in managing spinal pain with careful consideration and individualized decision-making. The future implementation of higher-quality systematic reviews and randomized controlled trials is crucial to providing more robust evidence to support or refute the use of spinal manual therapy for spinal pain conditions.

Background: Spinal and peripheral joint manipulation (MAN) and mobilization (MOB) are clinically recommended interventions for the treatment of musculoskeletal conditions. Although adverse events (AE) have been reported following these interventions, there is considerable heterogeneity in the terms, definitions and classification systems used to describe such AEs. A universally accepted definition and classification system has not yet been established. Recording and reporting of such events to improve patient safety is dependant on having standardised terminology.

Purpose: To establish an inter-professional and international standardized definition and severity classification for AE following MAN and MOB for adults with musculoskeletal conditions.

Methods: This sequential mixed-methods study included an electronic Delphi process (e-Delphi) with a published protocol followed by virtual focus groups. Inter-professional and international expert stakeholders were invited to participate. Participants included international and multidisciplinary MAN and MOB practitioners, educators and researchers, patients, medical doctors, regulators and medico-legal representatives. The e-Delphi process comprised 3 rounds: round 1 included open-ended questions on participants’ working definition and severity classification of AE; in round 2, participants rated their level of agreement with statements generated from round 1 and a previous scoping review of the literature; and in round 3, participants re-rated their agreement with statements achieving consensus in round 2. Focus groups were conducted with e-Delphi participants to further explore e-Delphi findings. Quantitative data were analysed descriptively to evaluate consensus (defined a priori) and qualitative data were analyzed using a theoretical thematic analysis.

Results: E-Delphi rounds 1, 2 and 3 had 183 (response rate: 85%), 163 (77%), and 153 (73%) respondents respectively, representing most continents and 9 expert stakeholder groups. Consensus was reached for severity categories (i.e., mild, moderate, severe and catastrophic) and on 2 domains to differentiate these categories (i.e., symptom intensity and impact on patients). Consensus was not reached for a standardized AE definition. Focus group discussions centered on acceptability and inclusion of "unfavourable”, “unexpected” and “undesired” terms in the AE definition and differences between “serious” and “catastrophic” severity classification categories.

Conclusion: A standardized severity classification was established with detailed descriptors for each category. The lack of consensus on a standardized definition for AE demonstrates the complexity of this topic. Findings may contribute to advancing patient safety and AE knowledge across professions through implementation of a common classification system.

Implications: The here-established severity classification facilitates and streamlines inter-professional and international dialogue regarding the reporting of AE following MAN and MOB in clinical practice and research. A universally accepted classification and common language enhances inter-profession collaboration, precision and accuracy in recording and reporting adverse events in research and clinical practice.

Background
Treatment fidelity (TF) is the degree to which interventions adhere to a planned protocol. Its 5 domains include treatment design, provider training, treatment delivery, treatment receipt and treatment enactment. Higher treatment fidelity increases the statistical power of results as well as internal and external validity. Orthopedic manual therapy (OMT) studies would benefit from a validated treatment fidelity tool that improves research design and patient outcomes.

Purpose
The objective of this study was to validate an OMT TF tool using a Delphi method. TF has been lacking and has yet to be fully acknowledged or successfully addressed in OMT research. Despite the adoption of numerous checklists to help guide researchers (TIDieR, Consort, PRISMA) there remains a need for improvement of OMT research quality.

Methods
After IRB approval, a two-phase sequential Delphi method was used to determine the validity of specific criteria important to high quality OMT research. The Delphi approach involved obtaining consensus from a group of 20 experts across 8 countries using a series of surveys which incorporated controlled feedback.

Results
The criteria that did not meet a 75% agreement after the first round were disregarded. Criteria that met the inclusion of 75% agreement after the second round were included in the tool. The response rate was 100% in round 1 and 91% percent in round 2. Agreement included 13 criteria in the 5 TF domains.

Conclusions
We completed a Delphi study to determine the appropriate criteria for a TF tool to enhance OMT research. Use of this tool by researchers will lead to improved TF and clinical validity of OMT techniques.

Implications
Higher TF increases the confidence that the outcome of interest is correlated to the OMT intervention performed. Using this tool may improve TF leading to higher quality OMT studies with more reliable results and potentially more efficient and effective clinical OMT interventions and improved patient outcomes.

Background:
Spinal manipulative therapy with an impulse of high velocity and low amplitude (HVLA-SMT) is clinically effective, most probably via an interplay between neurophysiological and biomechanical mechanisms. Previous systematic reviews reported positive effects for cervical and thoracic HVLA-SMT on cervical range of motion (ROM), but no systematic review focused on other biomechanical effects, apart from ROM. Furthermore, information on a possible link between the effects of HVLA-SMT and the purported clinical benefits is missing.

Purpose:
The aim of this systematic review was to assess the level of knowledge on the biomechanical effects of spinal HVLA-SMT in asymptomatic and symptomatic humans, as well as on the possible link between biomechanical effects and clinical effectiveness.

Methods:
A professional information specialist conducted a systematic literature in six databases (Medline (OvidSP), Premedline (PubMed), CINAHL, EMBASE, Cochrane, and Biosis). Two authors selected the studies according to predefined criteria (only randomized controlled trials included) and classified them into ‘low risk’, ‘some concerns’ or ‘high risk’ using the revised Cochrane risk-of-bias tool for randomized trials (RoB 2). Studies with high risk of bias (N=10) were excluded from the narrative synthesis.

Results:
The 33 included studies were heterogeneous in terms of participant characteristics, intervention and outcomes. The majority (27/33) reported on the effects of HVLA-SMT on spinal ROM. Evidence points towards an effect of thoracic HVLA-SMT on cervical range of motion (ROM) (all eight studies with a positive effect) and of cervical HVLA-SMT on cervical ROM (nine studies with a positive and six studies with no effect), while the effect on the respective ROM was less clear for lumbar (one large study reporting an effect, one small study reporting no effect) and thoracic (two studies with conflicting results) HVLA-SMT. The four studies on facet joint gapping (all conducted by the same research group) showed some effect of HVLA-SMT compared to side-posture positioning, and the single study on stiffness showed no effect of HVLA-SMT. Only a single study linked the biomechanical outcomes to pain or disability measures.

Conclusion(s):
HVLA-SMT, either applied to the cervical or the thoracic spine, appears to have a positive effect on cervical ROM. For all other outcomes, the included studies were too heterogeneous and too few for any sound conclusion. Future studies on biomechanical effects of HVLA-SMT should link the biomechanical to clinical outcomes such as pain and disability..

Implications:
HVLA-SMT either to the cervical or thoracic spine is an evidence-based tool to improve cervical range of motion. However, whether HVLA-SMT it leads to enhanced clinical outcome, such as reduction in pain and disability, is not clear.

Background:
Clinical guidelines recommend spinal manipulative therapy (SMT) as a treatment for spinal pain. Traditionally, SMT involves applying a specific thrust technique to a spinal target. However, previous systematic reviews of SMT suggest that the target site may not be significant for clinical outcomes. In addition, although there are multiple systematic reviews regarding SMT, none have examined whether the overall impact depends on the application procedures, such as where (the target) and how (the thrust) it is delivered.
Purpose:
We conducted a systematic review and network meta-analysis to identify the most effective SMT application procedures for reducing short-term pain and disability in patients with spinal pain. We compared a range of SMT interventions directly and indirectly with other guideline-recommended treatments and controls.
Methods:
Relevant RCTs comparing SMT to no-treatment controls, SMT sham, recommended and non-recommended therapies, or other types of SMT were identified through three search strategies: i) systematic, ii) explorative, and iii) known sources. Pairs of reviewers independently screened titles, abstracts, and full texts, extracted data, and assessed risk of bias using the revised Cochrane Risk of Bias Tool (ROB2). We conducted a frequentist network meta-analysis for the application site (e.g., symptomatic vs. non-symptomatic region) and the site rationale (e.g., clinician-selected vs. generic)
Results:
We included 151 trials (11,388 participants), with 84% rated high within-study risk of bias. Most SMT procedures were comparable to other recommended therapies and were slightly better than controls. However, inter-SMT procedure effects were small and statistically insignificant. Non-specific thrusts and generic targets provided the largest effects. Networks were consistent, with ~10% of direct comparisons showing inconsistency. Comparisons were based on low/very low confidence.
Conclusion:
Our findings suggest that a non-specific SMT approach may provide the largest effects for spinal pain and disability, albeit with minor differences compared to specific SMT approaches.
Implications:
We find ourselves amid a paradigm shift in how we understand SMT applications. Despite prior beliefs, clinicians should not concern themselves with specific thrust procedures or precise targets, as the clinical effects of SMT appear similar across these parameters. Consequently, clinicians should select SMT procedures factoring in patient and clinician safety, comfort, preferences, and body characteristics.
We encourage educational settings to de-emphasize teaching of target site specificity and specific techniques. Instead, we encourage students to explore different techniques in a safe environment while emphasizing psychomotor skills to facilitate safe and comfortable delivery of SMT.

Background
Manipulations or mobilizations are commonly used interventions in patients with mechanical neck pain. The treatment effects have often been studied in randomized controlled trials (RCT) which are generally considered the gold standard in evaluating the treatment effects, mainly due to its high internal validity. External validity is defined as the extent to which the effects can be generalised to clinical practice. An important prerequisite for this is that interventions used in clinical trials can be replicated in clinical practice. It can be questioned if interventions utilized in randomized controlled trials can be translated into clinical practice.

Objectives
The overall aim of this study is to examine whether the quality of the description of manipulation and mobilization interventions is sufficient for to replication of these interventions in clinical practice.

Methods: A comprehensive literature search was performed. Two independent researchers used the Template for Intervention Description and Replication (TIDieR) which is a 12-item checklist for describing the completeness of the interventions.

Results:
Sixty-seven articles were included that used manipulation and/ or mobilization interventions for patients with mechanical neck pain. None of the articles describe the intervention e.g. all the items on the TIDieR list. Considering item 8 (a-f) of the TIDieR checklist only one article described the intervention completely.

Conclusion:
Manipulation or a mobilization interventions are poorly reported in RCTs, which jeopardize the external validity of RCTs, making it difficult for clinicians and researchers to replicate these interventions.

Background: Low back pain (LBP), associated with spine, pelvis, and hip mobility impairments, can be caused by tight muscle contractions to protect sensitized tissues. Fascia tissue manipulations like myofascial release, soft tissue mobilizations, and elastic tape application are used to treat lumbar fasciae in LBP. The effect of fascia tissue manipulations through lumbodorsal skin displacement (SKD) on mobility is inconclusive, likely depending on the location and displacement direction of the manipulation. To indicate whether or not a patient would benefit from fascia tissue manipulations, a fascial diagnostic test procedure has been proposed (i.e., The Dynamic ArthroMyofascial Translation® Test). Although changes in joint mobility through SKD seem to be clinically effective, the basal effects of SKD on healthy subjects have not been objectively tested.

Purpose: This study aimed to assess whether lumbodorsal SKD affects the flexion and extension range of motion (ROM) in healthy subjects. Furthermore, the study tested the effect of SKD at different locations and directions. Finally, it assessed the intertester and intratester reliability of SKD.

Methods: Sixty-three healthy participants were randomly assigned to either the SKD or sham group. The SKD group was subjected to either mediolateral-directed SKD at the height of either L5 or L3 during a flexion or extension movement, while the sham group underwent displacement without SKD. The SKD was performed by two trained physiotherapists. Changes in range of motion (ROM) were assessed using motion capture to measure thoracic, lumbar, and hip angles, as well as finger-floor distance.

Results: Statistics indicated that flexion and extension ROM were affected by SKD (p < 0.05) and not by sham displacement. Flexion ROM decreased, whereas the extension ROM increased, depending on SKD location and displacement direction (p < 0.05). The ICC indicates good intertester and intratester reliability (ICC3, k = .81-.93; ICC3,1 = 0.70-0.84).

Conclusions: SKD at the lower back substantially affects the flexion and extension range of motion in the spine, pelvis, and hip. The effects of SKD are direction and location-dependent, as well as movement (flexion/extension) specific. Further research is warranted to gain insight into the mechanisms by which SKD affects the spine, pelvis, and hip range of motion, muscle activation, and force transmission in healthy, asymptomatic, and low back pain subjects.

Implications: SKD during flexion and extension may be useful to determine whether a patient would benefit from fascia tissue manipulations, which is an ongoing study at this moment. The ongoing study aims to ascertain if SKD affects the spine, pelvis, and hip range of motion, back muscle flexion relaxation, and relative tissue displacement (ultrasound speckle tracking) in LBP and matching healthy subjects. Preliminary results of these studies are expected to be presented.