Transcutaneous auricular vagus nerve stimulation modifies cortical excitability in middle-aged and older adults.

There is a growing interest in the clinical application of transcutaneous auricular vagus nerve stimulation (taVNS). However, its effect on cortical excitability, and whether this is modulated by stimulation duration, remains unclear. We evaluated whether taVNS can modify excitability in the primary motor cortex (M1) in middle-aged and older adults and whether the stimulation duration moderates this effect. In addition, we evaluated the blinding efficacy of a commonly reported sham method. In a double-blinded randomized cross-over sham-controlled study, 23 healthy adults (mean age 59.91 ± 6.87 years) received three conditions: active taVNS for 30 and 60 min and sham for 30 min. Single and paired-pulse transcranial magnetic stimulation was delivered over the right M1 to evaluate motor-evoked potentials. Adverse events, heart rate and blood pressure measures were evaluated. Participant blinding effectiveness was assessed via guesses about group allocation. There was an increase in short-interval intracortical inhibition (F = 7.006, p = .002) and a decrease in short-interval intracortical facilitation (F = 4.602, p = .014) after 60 min of taVNS, but not 30 min, compared to sham. taVNS was tolerable and safe. Heart rate and blood pressure were not modified by taVNS (p > .05). Overall, 96% of participants detected active stimulation and 22% detected sham stimulation. taVNS modifies cortical excitability in M1 and its effect depends on stimulation duration in middle-aged and older adults. taVNS increased GABAAergic inhibition and decreased glutamatergic activity. Sham taVNS protocol is credible but there is an imbalance in beliefs about group allocation.

The clinical course of acute, subacute and persistent low back pain: a systematic review and meta-analysis.

BACKGROUND: Understanding the clinical course of low back pain is essential to informing treatment recommendations and patient stratification. Our aim was to update our previous systematic review and meta-analysis to gain a better understanding of the clinical course of acute, subacute and persistent low back pain. METHODS: To update our 2012 systematic review and meta-analysis, we searched the Embase, MEDLINE and CINAHL databases from 2011 until January 2023, using our previous search strategy. We included prospective inception cohort studies if they reported on participants with acute (< 6 wk), subacute (6 to less than 12 wk) or persistent (12 to less than 52 wk) nonspecific low back pain at study entry. Primary outcome measures included pain and disability (0-100 scale). We assessed risk of bias of included studies using a modified tool and assessed the level of confidence in pooled estimates using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) tool. We used a mixed model design to calculate pooled estimates (mean, 95% confidence interval [CI]) of pain and disability at 0, 6, 12, 26 and 52 weeks. We treated time in 2 ways: time since study entry (inception time uncorrected) and time since pain onset (inception time corrected). We transformed the latter by adding the mean inception time to the time of study entry. RESULTS: We included 95 studies, with 60 separate cohorts in the systematic review (n = 17 974) and 47 cohorts (n = 9224) in the meta-analysis. Risk of bias of included studies was variable, with poor study attrition and follow-up, and most studies did not select participants as consecutive cases. For the acute pain cohort, the estimated mean pain score with inception time uncorrected was 56 (95% CI 49-62) at baseline, 26 (95% CI 21-31) at 6 weeks, 22 (95% CI 18-26) at 26 weeks and 21 (95% CI 17-25) at 52 weeks (moderate-certainty evidence). For the subacute pain cohort, the mean pain score was 63 (95% CI 55-71) at baseline, 29 (95% CI 22-37) at 6 weeks, 29 (95% CI 22-36) at 26 weeks and 31 (95% 23-39) at 52 weeks (moderate-certainty evidence). For the persistent pain cohort, the mean pain score was 56 (95% CI 37-74) at baseline, 48 (95% CI 32-64) at 6 weeks, 43 (95% CI 29-57) at 26 weeks and 40 (95% CI 27-54) at 52 weeks (very low-certainty evidence). The clinical course of disability was slightly more favourable than the clinical course of pain. INTERPRETATION: Participants with acute and subacute low back pain had substantial improvements in levels of pain and disability within the first 6 weeks ( moderate-certainty evidence); however, participants with persistent low back pain had high levels of pain and disability with minimal improvements over time (very low-certainty evidence). Identifying and escalating care in individuals with subacute low back pain who are recovering slowly could be a focus of intervention to reduce the likelihood of transition into persistent low back pain. PROTOCOL REGISTRATION: PROSPERO - CRD42020207442.

The EPIPHA-KNEE trial: Explaining Pain to target unhelpful pain beliefs to Increase PHysical Activity in KNEE osteoarthritis - a protocol for a multicentre, randomised controlled trial with clinical- and cost-effectiveness analysis.

BACKGROUND: Despite well-established benefits of physical activity for knee osteoarthritis (OA), nine of ten people with knee OA are inactive. People with knee OA who are inactive often believe that physical activity is dangerous, fearing that it will further damage their joint(s). Such unhelpful beliefs can negatively influence physical activity levels. We aim to evaluate the clinical- and cost-effectiveness of integrating physiotherapist-delivered pain science education (PSE), an evidence-based conceptual change intervention targeting unhelpful pain beliefs by increasing pain knowledge, with an individualised walking, strengthening, and general education program. METHODS: Two-arm, parallel-design, multicentre randomised controlled trial involving 198 people aged ≥50 years with painful knee OA who do not meet physical activity guideline recommendations or walk regularly for exercise. Both groups receive an individualised physiotherapist-led walking, strengthening, and OA/activity education program via 4x weekly in-person treatment sessions, followed by 4 weeks of at-home activities (weekly check-in via telehealth), with follow-up sessions at 3 months (telehealth) and 5 and 9 months (in-person). The EPIPHA-KNEE group also receives contemporary PSE about OA/pain and activity, embedded into all aspects of the intervention. Outcomes are assessed at baseline, 12 weeks, 6 and 12 months. Primary outcomes are physical activity level (step count; wrist-based accelerometry) and self-reported knee symptoms (WOMAC Total score) at 12 months. Secondary outcomes are quality of life, pain intensity, global rating of change, self-efficacy, pain catastrophising, depression, anxiety, stress, fear of movement, knee awareness, OA/activity conceptualisation, and self-regulated learning ability. Additional measures include adherence, adverse events, blinding success, COVID-19 impact on activity, intention to exercise, treatment expectancy/perceived credibility, implicit movement/environmental bias, implicit motor imagery, two-point discrimination, and pain sensitivity to activity. Cost-utility analysis of the EPIPHA-KNEE intervention will be undertaken, in addition to evaluation of cost-effectiveness in the context of primary trial outcomes. DISCUSSION: We will determine whether the integration of PSE into an individualised OA education, walking, and strengthening program is more effective than receiving the individualised program alone. Findings will inform the development and implementation of future delivery of PSE as part of best practice for people with knee OA. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12620001041943 (13/10/2020).

Towards more credible shams for physical interventions: A Delphi survey.

BACKGROUND/AIMS: In clinical trials of physical interventions, participant blinding is often poorly addressed and therapist blinding routinely omitted. This situation presents a substantial barrier to moving the field forward. Improving the success of blinding will be a vital step towards determining the true mechanisms of physical interventions. We used a Delphi approach to identify important elements of shams for physical interventions to maximise the likelihood of participant and therapist blinding in clinical trials. METHODS: Two expert groups were recruited: (1) experts in research methodology and (2) experts in deceptive and/or hypnotic techniques including magic. Magicians were included because they were considered a potentially rich source of innovation for developing credible shams due to their unique skills in altering perceptions and beliefs. Three rounds of survey were conducted, commencing with an open-ended question. Responses were converted to single 'items', which participants rated in the following two rounds using a 9-point Likert scale, categorised as 'Not important' (0-3), 'Depends' (4-6) and 'Essential' (7-9). Consensus was pre-defined as ≥80% agreement within a 3-point category. RESULTS: Thirty-eight experts agreed to participate (research methodology: n = 22; deceptive and/or hypnotic techniques: n = 16), and 30 experts responded to at least one round (research methodology: n = 19; deceptive and/or hypnotic techniques: n = 11). Of 79 items, five reached consensus in the 'Essential' category in both groups, which related to beliefs of participants (n = 3 items), interactions with researchers (n = 1 item) and standardisation of clinical assessments (n = 1 item). Thirteen additional items reached consensus in the 'Essential' category in one group. Experts in research methodology had one additional item reach consensus, related to authentic delivery of study information. The remaining 12 additional items that reached consensus in the deceptive and/or hypnotic techniques group related mainly to therapist attitude and behaviour and the clinical interaction. CONCLUSION: Experts agreed that, for shams to be believable, consideration of cognitive influences is essential. Contrary to the focus of previous shams for physical interventions, replicating the tactile sensation of the active treatment was not considered an essential part of sham development. Therefore, when designing sham-controlled clinical trials, researchers should carefully consider the cognitive credibility of the entire intervention experience, and not just the indistinguishability of the sham intervention itself. The findings provide new guidance to researchers on important contributors to blinding in physical intervention trials.

Painful distortions: people with painful knee osteoarthritis have biased visuospatial perception of the environment.

ABSTRACT: Visuospatial perception is thought to be adaptive-ie, hills are perceived as steeper when capacity is low, or threat is high-guiding appropriate interaction with the environment. Pain (bodily threat) may similarly modulate visuospatial perception, with the extent of modulation influenced by threat magnitude (pain intensity, fear) and associated with behaviour (physical activity). We compared visuospatial perception of the environment between 50 people with painful knee osteoarthritis and 50 age-/sex-matched pain-free control participants using 3 virtual reality tasks (uphill steepness estimation, downhill steepness estimation, and a distance-on-hill measure), exploring associations between visuospatial perception, clinical characteristics (pain intensity, state and trait fear), and behaviour (wrist-worn accelerometry) within a larger knee osteoarthritis group (n = 85). People with knee osteoarthritis overestimated uphill (F1,485 = 19.4, P < 0.001) and downhill (F1,480 = 32.3, P < 0.001) steepness more so than pain-free controls, but the groups did not differ for distance-on-hill measures (U = 1273, P = 0.61). There was also a significant group x steepness interaction for the downhill steepness task (F4,480 = 3.11, P = 0.02). Heightened overestimation in people with knee osteoarthritis relative to pain-free controls increased as downhill slopes became steeper. Results were unchanged in a replication analysis using all knee osteoarthritis participants (n = 85), except the downhill steepness interaction was no longer significant. In people with knee osteoarthritis, higher state fear was associated with greater over-estimation of downhill slope steepness (rho = 0.69, P < 0.001), and greater visuospatial overestimation (distance-on-hill) was associated with lower physical activity levels (rho = -0.22, P = 0.045). These findings suggest that chronic pain may shift perception of the environment in line with protection, with overestimation heightened when threat is greater (steeper hills, more fearful), although impact on real-world behaviour is uncertain.

The effectiveness of peer support interventions for community-dwelling adults with chronic musculoskeletal pain: a systematic review and meta-analysis of randomised trials.

ABSTRACT: This systematic review and meta-analysis critically examined the evidence for peer support interventions to reduce pain and improve health outcomes in community-dwelling adults with chronic musculoskeletal pain (PROSPERO CRD42022356850). A systematic search (inception-January 2023) of electronic databases and grey literature was undertaken to identify relevant randomised controlled trials, with risk of bias and GRADE assessments performed on included studies. Meta-analyses used a generic, inverse-variance, random-effects model, calculating mean difference (MD) or standardised mean difference (SMD). Of 16,445 records identified, 29 records reporting on 24 studies (n = 6202 participants) were included. All evidence had unclear/high risk of bias and low-very low certainty. Peer support interventions resulted in small improvements in pain (medium-term: MD -3.48, 95% CI -6.61, -0.35; long-term: MD -1.97, 95% CI -3.53, -0.42), self-efficacy (medium-term: SMD 0.26, 95% CI 0.16, 0.36; long-term: SMD 0.21, 95% CI 0.07, 0.36), and function (long-term: SMD -0.10, 95% CI -0.19, -0.00) relative to usual care and greater self-efficacy (medium-term: SMD 0.36, 95% CI 0.20, 0.51) relative to waitlist control. Peer support interventions resulted in similar improvement as active (health professional led) interventions bar long-term self-efficacy (MD -0.41, 95% CI -0.77, -0.05), which favoured active interventions. No point estimates reached minimal clinically important difference thresholds. Pooled health service utilisation outcomes showed unclear estimates. Self-management, quality of life, and social support outcomes had mixed evidence. Despite low-very low evidence certainty, peer support interventions demonstrated small improvements over usual care and waitlist controls for some clinical outcomes, suggesting that peer support may be useful as an adjunct to other treatments for musculoskeletal pain.

The influence of threat on visuospatial perception, affordances, and protective behaviour: A systematic review and meta-analysis.

Perception has been conceptualised as an active and adaptive process, based upon incoming sensory inputs, which are modified by top-down factors such as cognitions. Visuospatial perception is thought to be scaled based on threat, with highly threatening objects or contexts visually inflated to promote escape or avoidance behaviours. This meta-analytical systematic review quantified the effect and evidence quality of threat-evoked visuospatial scaling, as well as how visuospatial scaling relates to affordances (perceived action capabilities) and behavioural avoidance/escape outcomes. Databases and grey literature were systematically searched inclusive to 10/04/24. Studies were assessed with a customised Risk of Bias form and meta-analysis was performed using a random-effects model. 12,354 records were identified. Of these, 49 experiments (n = 3027) were included in the review. There was consistent evidence that threat the of height influenced contextual perception (g = 0.66, 95% CI: 0.45, 0.88) and affordances (g = -0.43, 95% CI: -0.84, -0.03). Threatening objects were viewed as larger (g = 0.76, 95% CI: 0.26, 1.26) and as closer (g = 0.30, 95% CI: 0.17, 0.42). Bodily threat (pain) yielded conflicting effects on visuospatial perception/affordances. We conclude that threat may influence visuospatial perception and affordances. However, since behavioural measures were poorly reported, their relationship with visuospatial perception/affordances remains elusive.

People with painful knee osteoarthritis hold negative implicit attitudes towards activity.

ABSTRACT: Negative attitudes/beliefs surrounding osteoarthritis, pain, and activity contribute to reduced physical activity in people with knee osteoarthritis (KOA). These attitudes/beliefs are assessed using self-report questionnaires, relying on information one is consciously aware of and willing to disclose. Automatic (ie, implicit) assessment of attitudes does not rely on conscious reflection and may identify features unique from self-report. We developed an implicit association test that explored associations between images of a person moving/twisting their knee (activity) or sitting/standing (rest), and perceived threat (safe vs dangerous). We hypothesised that people with KOA would have greater implicit threat-activity associations (vs pain-free and non-knee pain controls), with implicit attitudes only weakly correlating with self-reported measures (pain knowledge, osteoarthritis/pain/activity beliefs, fear of movement). Participants (n = 558) completed an online survey: 223 had painful KOA (n = 157 female, 64.5 ± 8.9 years); 207 were pain free (n = 157 female, 49.3 ± 15.3 years); and 99 had non-KOA lower limb pain (n = 74 female, 47.5 ± 15.04 years). An implicit association between "danger" and "activity" was present in those with and without limb pain (KOA: 0.36, 95% CI 0.28-0.44; pain free: 0.13, 95% CI 0.04-0.22; non-KOA lower limb pain 0.11, 95% CI -0.03 to 0.24) but was significantly greater in the KOA group than in the pain free (P < 0.001) and non-KOA lower limb pain (P = 0.004) groups. Correlations between implicit and self-reported measures were nonsignificant or weak (rho = -0.29 to 0.19, P < 0.001 to P = 0.767). People with painful KOA hold heightened implicit threat-activity associations, capturing information unique to that from self-report questionnaires. Evaluating links between implicit threat-activity associations and real-world behaviour, including physical activity levels, is warranted.

Get Your Head in the Game: A Replicated Single-Case Experimental Design Evaluating the Effect of a Novel Virtual Reality Intervention in People With Chronic Low Back Pain.

Chronic low back pain (CLBP) is a leading cause of disability worldwide. Contemporary treatment of CLBP is suboptimal, with small-moderate effect sizes and high relapse rates. Virtual reality (VR) is an increasingly accessible technology that can improve adherence to exercise programs through gamification. Using VR to facilitate exercise adherence and enjoyment may improve the clinical outcomes. This study aimed to evaluate the effects of a gamified VR graded activity intervention in people with CLBP, using commercially available and bespoke VR programs. A sequentially replicated, multiple-baseline, randomized AB single-case experimental design was undertaken in 10 people with CLBP. Outcomes were assessed daily and included pain intensity (primary) and pain catastrophizing, pain-related fear, and anxiety/worry (secondary). The effect of the intervention on the primary outcome was evaluated using a multilevel-model, nonparametric randomization test. The VR graded activity intervention resulted in a significant reduction in pain intensity (effect estimate = -1.0, standard error = .27, P < .0011) with 4 participants achieving ≥30% pain reduction (minimum important change). There was a significant effect of the intervention on pain catastrophizing but not pain-related fear or anxiety/worry measures. These findings provide preliminary support for a VR graded activity program to reduce pain in people with CLBP. PERSPECTIVE: This novel, VR graded activity intervention reduced pain intensity and catastrophizing in people with CLBP. The intervention also had high adherence and enjoyment. Given that this intervention involved 2 freely available VR programs, it can be easily translated into clinical practice.

Item development and pre-testing of an Osteoarthritis Conceptualisation Questionnaire to assess knowledge and beliefs in people with knee pain.

Many people with osteoarthritis hold beliefs that physical activity is unhelpful or dangerous for their joints, despite high-level evidence suggesting otherwise. Recent advances in scientific understanding of osteoarthritis have led to new treatments that target an individual's understanding both of their condition and the importance of best-practice management strategies, such as physical activity. Conceptual change has been proposed as an important mechanism by which cognitive interventions, such as pain science education, may reduce pain and improve function. There are currently no specific assessments of osteoarthritis conceptualisation to determine the effectiveness of cognitive interventions in effecting conceptual change in people with knee osteoarthritis. Therefore, we aimed to develop an item bank, as the first phase of developing a questionnaire to assess people's conceptualisations about their knee osteoarthritis and the role of physical activity in managing their osteoarthritis. Using a guideline-informed mixed method design, a panel of experts identified domains relevant to conceptualisation about knee osteoarthritis and physical activity (knowledge, beliefs, understanding) based upon available evidence. The panel created 33 provisional items. Qualitative and quantitative pretesting were used to explore how people with knee osteoarthritis understood the provisional items. Eighteen people with knee osteoarthritis completed cognitive interviews about their comprehension of the wording/grammar of each provisional item. The provisional item bank was field tested with 100 people with knee osteoarthritis. Readability was adequate with a Flesch reading ease score of 57.7. Although 14.7% used the 'Strongly agree' response option, only 3.4% of responses used the 'Strongly disagree' option, suggesting possible response bias. Predictive quality testing identified relevant modifications to the questionnaire instructions. The panel of experts appraised the qualitative data to assess whether and how items should be modified to address the problems identified, resulting in a final item bank of 45 items that can be evaluated for psychometric properties in future research.

Does who I am and what I feel determine what I see (or say)? A meta-analytic systematic review exploring the influence of real and perceived bodily state on spatial perception of the external environment.

Background: Bodily state is theorised to play a role in perceptual scaling of the environment, whereby low bodily capacity shifts visuospatial perception, with distances appearing farther and hills steeper, and the opposite seen for high bodily capacity. This may play a protective role, where perceptual scaling discourages engaging with the environment when capacity is low. Methodology: Our protocol was pre-registered via Open Science Framework (https://osf.io/6zya5/) with all amendments to the protocol tracked. We performed a systematic review and meta-analysis examining the role of bodily state/capacity on spatial perception measures of the environment. Databases (Medline, PsychINFO, Scopus, Embase, and Emcare) and grey literature were searched systematically, inclusive to 26/8/21. All studies were assessed using a customised Risk of Bias form. Standard mean differences and 95% CIs were calculated via meta-analysis using a random-effects model. Results: A total of 8,034 studies were identified from the systematic search. Of these, 68 experiments (3,195 participants) met eligibility and were included in the review. These were grouped into the following categories: fatigue; pain; age; embodiment; body size/body paty size; glucose levels; fitness; and interoception, and interoceptive accuracy. We found low level evidence (limited studies, high risk of bias) for the effect of bodily state on spatial perception. There was consistent evidence that both glucose manipulations and age influence spatial perception of distances and hills in a hypothesised direction (lower capacity associated with increased distance and hill steepness). Mixed evidence exists for the influence of external loads, embodiment, body/body-part size manipulations, pain, and interoceptive accuracy. Evidence for fitness and/or fatigue influencing spatial perception was conflicting; notably, methodological flaws with fitness and fatigue paradigms and heterogenous spatial perception measures may underlie null/conflicting results. Conclusion: We found limited evidence for bodily state influencing spatial perception of the environment. That all studies had high risk of bias makes conclusions about reported effects reflecting actual perceptual shifts (vs merely reflecting experimental demands or error due to inadequate study design) pre-emptive. Rigorous evaluation is needed to determine whether reported effects reflect more than bias (e.g., experimental demands, inadequate blinding). Future work using reliable measures of spatial perception, comprehensive evaluation of relevant confounders, and methodologically robust (and experimentally confirmed) bodily state experimental paradigms is warranted.

What do I need to know? Essential educational concepts for complex regional pain syndrome.

BACKGROUND: Complex Regional Pain Syndrome (CRPS) is a rare but disabling pain condition. Accurate and timely education about CRPS is key to promote optimal clinical outcomes, but it is unclear what the content of that education should be. We aimed to determine the content that both people with CRPS and expert health care professionals (HCPs) reported as important. METHODS: An international three-round e-Delphi was conducted, recruiting adults diagnosed with CRPS and HCPs. In Round 1, participants were asked to list the most important information people with CRPS should know regarding the condition. Data were organized into concepts and allocated to themes. In Rounds 2 and 3, participants rated each concept on a 9-point Likert Scale, categorized as 'not important' (0-3), 'important' (4-6) and 'very important' (7-9). A concept attained consensus when ≥75% agreement was reached within a category. RESULTS: Sixty-two participants (HCPs: n = 7; CRPS: n = 55) proposed 193 concepts in Round 1, resulting in 22 themes. Fifteen additional concepts were identified in Round 2, resulting in a total of 208 concepts. From that list, 48 concepts that emphasized understanding and evidence-based management of the disorder, the importance of self-management strategies, pacing and movement, reached joint consensus as 'very important'. One concept: 'Advise that movement does not help' reached joint consensus as 'not important'. CONCLUSION: Forty-eight concepts were jointly considered 'very important' for future CRPS-related educational content. Future research to better understand group differences and to canvas a broader HCP group is warranted. SIGNIFICANCE: This e-Delphi study identified the 48 core concepts that those with the lived experience of CRPS, and advanced practitioner health care professionals jointly rated as 'very important' to include in fundamental and accessible educational material.

Reframe the pain: Divided attention and positive memory reframing to reduce needle pain and distress in children-A feasibility randomized controlled trial.

BACKGROUND: Negative experiences of needle procedures in childhood can lead to medical avoidance and vaccine hesitancy into adulthood. We evaluated the feasibility of two new interventions provided by clinical nurses to reduce the negative impact of vaccinations: divided attention (DA) and positive memory reframing (PMR). METHODS: Children (8-12 years) were randomized into four groups: usual care (UC), DA, PMR or combined (DA + PMR). To evaluate feasibility, we undertook in-depth analysis of video-recorded interventions, nurse experiences (phone interviews) and child/parent memory recall of interventions (phone interviews at 2 weeks post-vaccination). Key clinical outcomes included child and parent ratings of needle-related pain intensity and fear assessed at baseline, immediately post-vaccination and 2 weeks post-vaccination (recalled). RESULTS: A total of 54 child-parent dyads were screened, with 41 included (10/group, except PMR [n = 11]). The interventions were not always completed as intended: 10%-22% of participants received complete interventions and two had adverse events related to protocol breach. Preliminary within-group analyses showed no effects on child/parent pain ratings. However, children in DA + PMR had reduced recalled fear (p = 0.008), and PMR (p = 0.025) and DA + PMR (p = 0.003) had reduced fear of future needles. Parent ratings of child fear were also reduced immediately post-vaccination for UC (p = 0.035) and PMR (p = 0.035). CONCLUSIONS: The interventions were feasible, although enhanced nurse training is required to improve fidelity. Preliminary clinical results appear promising, particularly for reducing needle-related fear. PROTOCOL REGISTRATION: Protocol number ACTRN12618000687291 at ANZCTR.org.au SIGNIFICANCE: Two new nurse-led interventions to reduce negative impacts of vaccinations in children, divided attention and positive memory reframing, were feasible and may reduce needle-related fear. Nurses were able to deliver the interventions in various environments including non-clinical settings (schools). These interventions have potential to facilitate broader dissemination of vaccinations for children in a manner that minimizes distress.

Effects of previous experience with dry needling therapy on blinding effectiveness and pain outcomes in people with neck pain: A preliminary sham-controlled study.

BACKGROUND: Participants' previous experience with an intervention may be an important variable when conducting sham-controlled trials. OBJECTIVE: This study explored if previous experience with dry needling (DN) influenced blinding effectiveness and pain outcomes, after the application of DN in patients with neck pain. DESIGN: A preliminary randomized, sham-controlled study. METHODS: Participants were randomized to receive a single session of real or sham DN. Previous experience with DN (yes/no) was recorded. Blinding effectiveness was assessed by asking participants to guess their group allocation (real/sham/not sure) 5 min post-intervention. Outcomes including pain intensity, pressure pain thresholds, and self-perceived improvement, were assessed by a blinded assessor at baseline, one- and seven-days post-intervention. RESULTS: Of 50 patients recruited, 30 had previous experience and 20 did not. Fifty-seven percent (n = 17/30) with previous experience and 35% (n = 7/20) without experience correctly identified their group allocation, but this difference was not significant (χ2 = 2.333; P = 0.127). No interaction between previous experience and clinical outcomes were found, except that participants with previous experience receiving real DN showed greater improvements in pain during cervical rotation than those without previous experience at one (Δ -11.5 mm 95%CI -22.0 to -1.0 mm) and seven days (Δ -8.5 mm, -16.00 to -1.0 mm) post-intervention. CONCLUSIONS: Participants with previous experience were 22% more accurate at identifying their group allocation than those without experience, but the difference was not significant. Previous experience did not influence most clinical outcomes, except for pain intensity after real DN. Future studies evaluating effects of previous experience of DN should include more detailed information of previous experience.

Suggestions in Hypnosis to Aid Pain Education (SHAPE) in People with Chronic Low-Back Pain: A Pilot Feasibility Randomized, Controlled Trial.

Chronic low back pain (CLBP) is a debilitating and burdensome condition, and new treatment strategies are needed. This study aimed to evaluate (1) the feasibility of undertaking a controlled clinical trial investigating a novel intervention for people with CLBP: hypnotically reinforced pain science education, and (2) the acceptability of the intervention as rated by participants. A priori feasibility and intervention acceptability criteria were set. Twenty participants with CLBP were recruited and randomized to receive: (1) hypnotically delivered pain science education that utilizes hypnotic suggestions to enhance uptake of pain science concepts; or (2) pain science education with progressive muscle relaxation as an attention control. Twenty participants were recruited, however, not solely from the hospital waitlist as intended; community sampling was required (13 hospital, 7 community). Most criteria were met in the community sample but not the hospital sample. Protocol modifications are needed before progressing to a full scale randomized controlled trial for hypnotically reinforced pain science education. Improvements in relevant secondary outcomes paired with moderate-high treatment acceptability ratings are promising.

Does readiness to change influence pain-related outcomes after an educational intervention for people with chronic pain? A pragmatic, preliminary study.

Background: There is a strong association between chronic pain and unhelpful pain cognitions. Educating patients on pain neuroscience has been shown to reduce pain catastrophization, kinesiophobia, and self-perceived disability. This study investigated whether a group-based pain neuroscience education (PNE) session influenced pain-related outcomes, and whether readiness to change moderated these outcomes.Method: In a pragmatic pre-post-intervention study using a convenience sample, adults with chronic pain participated in one, 90-120 minute PNE session. Pain-related outcomes (i.e. pain catastrophization, kinesiophobia, disability, and pain neuroscience knowledge) and the Pain Stage of Change Questionnaire (PSOCQ) were assessed at baseline and immediately post-intervention. Paired t-tests evaluated pre-post changes in outcomes, and linear regression examined the impact of PSOCQ score changes on PNE-induced changes in clinical outcomes.Results: Sixty-five participants were recruited. All outcomes showed positive intervention effects (p < .01). Relationships between changes in PSOCQ subscale scores and change in post-intervention pain-related outcomes were found; 'Pre-Contemplation' was positively associated with pain catastrophization (p = .01), and 'Action' was negatively associated with kinesiophobia (p = .03).Conclusion: Consistent with previous research, there were improvements in outcomes associated with chronic pain after PNE. Some of these improvements were predicted by changes in PSOCQ scores, however, these findings are preliminary and require further investigation using controlled research designs.

A novel blinding protocol to test participant and therapist blinding during dry needling: a randomised controlled experiment.

OBJECTIVES: Dry needling is widely used in physiotherapy. Lack of blinding in clinical trials means that dry needling effects and mechanisms remain unclear, with blinding issues accepted as an unavoidable barrier to better evidence. The authors aimed to overcome this barrier by designing a protocol to double-blind dry needling trials. DESIGN: A prospectively registered randomised experiment tested a novel blinding protocol for blinding effectiveness. SETTING: University physiotherapy clinic. PARTICIPANTS: Therapists (n=15) and asymptomatic volunteers ('recipients') (n=45) were randomly allocated to real and/or sham interventions. INTERVENTIONS: The protocol involved custom-made needles and cognitive and multisensory blinding techniques. MAIN OUTCOME MEASURES: The primary outcome was guesses about allocation. The a priori criterion for successful blinding was ≤50% correct guesses (random chance). Secondary analyses explored blinding patterns using blinding indices. RESULTS: Correct guesses were not different from 50% for therapists [41% (95%CI 30 to 50), n=120 guesses] or recipients [49% (95%CI 38 to 60), n=90 guesses]. Blinding indices supported the primary result but revealed that recipients were better at detecting real dry needling than sham. CONCLUSION: Both therapists and recipients were successfully blinded, which contrasts with the widely held assumption that double-blinding is impossible for needling interventions. The authors recommend that any future trials can, and therefore should, blind therapists. However, secondary analyses revealed that recipients receiving real dry needling were less blinded than sham recipients, which may still create bias in clinical trials and suggests further work is needed to improve recipient blinding. Nonetheless, the current findings offer an opportunity to gain better evidence concerning the effects and mechanisms of dry needling. STUDY REGISTRATION: https://osf.io/rkzeb/.

A collaborative experiential problem-solving approach to develop shams for complex physical interventions: a case study of dry needling.

OBJECTIVE: Complex physical interventions are widely used in physiotherapy, despite doubts over the validity of clinical trial results due to lack of credible shams. Credible shams are critically needed, so too, therefore, is a process by which they can be developed. The authors used a novel methodology to develop and test blinding protocols for dry needling, a complex physical intervention for which blinding is particularly difficult. DESIGN: The research design was a practical three-day workshop influenced by Participatory Action Research, which uses iteration and reflection to solve a problem. PARTICIPANTS: Five multidisciplinary experts (researchers, clinicians, technician, magician) were invited. Healthy volunteers ('recipients', n=17) and accredited physiotherapists (n=6) were recruited to enable testing of blinding strategies. MAIN OUTCOME MEASURES: Primary outcomes were expert opinion on the potential to blind recipients/therapists for (1) individual blinding strategies, and (2) entire blinding protocols. Secondary outcomes included recipient/therapist blinding effectiveness and acceptability. RESULTS: Experts iteratively developed 11 blinding protocols involving 22 blinding strategies. Experts rated 18 of the blinding strategies to 'definitely have potential' and identified four categories: knowledge of the sham, clinical interaction, disinformation, and sensation. Recipient and therapist blinding became more successful as the protocols evolved. CONCLUSIONS: Credible shams capable of simultaneous recipient and therapist blinding have been regarded to be impossible in dry needling. The preliminary success of the devised protocols suggest that our novel approach may be a crucial step in sham development. Improvements in expert rankings and blinding effectiveness as the protocols progressed support the value of this workshop approach.

Where is my arm? Investigating the link between complex regional pain syndrome and poor localisation of the affected limb.

BACKGROUND: Anecdotally, people living with Complex Regional Pain Syndrome (CRPS) often report difficulties in localising their own affected limb when it is out of view. Experimental attempts to investigate this report have used explicit tasks and yielded varied results. METHODS: Here we used a limb localisation task that interrogates implicit mechanisms because we first induce a compelling illusion called the Disappearing Hand Trick (DHT). In the DHT, participants judge their hands to be close together when, in fact, they are far apart. Sixteen volunteers with unilateral upper limb CRPS (mean age 39 ± 12 years, four males), 15 volunteers with non-CRPS persistent hand pain ('pain controls'; mean age 58 ± 13 years, two males) and 29 pain-free volunteers ('pain-free controls'; mean age 36 ± 19 years, 10 males) performed a hand-localisation task after each of three conditions: the DHT illusion and two control conditions in which no illusion was performed. The conditions were repeated twice (one for each hand). We hypothesised that (1) participants with CRPS would perform worse at hand self-localisation than both the control samples; (2) participants with non-CRPS persistent hand pain would perform worse than pain-free controls; (3) participants in both persistent pain groups would perform worse with their affected hand than with their unaffected hand. RESULTS: Our first two hypotheses were not supported. Our third hypothesis was supported -when visually and proprioceptively encoded positions of the hands were incongruent (i.e. after the DHT), relocalisation performance was worse with the affected hand than it was with the unaffected hand. The similar results in hand localisation in the control and pain groups might suggest that, when implicit processes are required, people with CRPS' ability to localise their limb is preserved.