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.

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/.

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.

Towards more homogenous and rigorous methods in sham-controlled dry needling trials: two Delphi surveys.

OBJECTIVES: Sham-controlled trials of dry needling, a popular treatment for pain, use a range of methods and theoretical frameworks and most have high risk of bias. Critically, patient blinding is often unsuccessful and therapist blinding has not been attempted. The specific effects of dry needling on pain therefore remain unclear. Our objectives were to identify (1) important elements of active dry needling; (2) important elements of shams for dry needling. DESIGN AND PARTICIPANTS: Two Delphi surveys (to quantify levels of consensus) were undertaken with three expert groups: experts in (1) dry needling, (2) research methodology, and (3) deceptive/hypnotic techniques including magic. Experts in dry needling participated in Delphi 1 and all three groups participated in Delphi 2. Each survey commenced with an open-ended question. Responses were converted to single 'items' suitable for rating on 9-point Likert scales [categorised as 'Not important' (0-3), Depends (4-6), and Essential (7-9)], which participants rated in the following two rounds. Consensus was pre-defined as ≥80% agreement within a 3-point category. RESULTS: In Delphi 1 (n=20 experts), of 80 items, 35 reached consensus in the 'Essential' category, which related to explanations, therapist knowledge/skills, intervention rationale, the setting, and safety. In Delphi 2 (n=53 experts), of 97 items, 15 items reached consensus in the 'Essential' category in all three groups, which related to standardisation/indistinguishability, therapist attributes, expectations/beliefs, vision, protocol, and environment. CONCLUSIONS: Experts placed high importance on the entire intervention experience for active and sham protocols. Cognitive influences that extend beyond mimicking of tactile sensations should be used to create a believable simulation of active dry needling.

Blinding Strategies in Dry Needling Trials: Systematic Review and Meta-Analysis.

BACKGROUND: Blinding of participants and therapists in trials of physical interventions is a significant and ongoing challenge. There is no widely accepted sham protocol for dry needling. PURPOSE: The purpose of this review was to summarize the effectiveness and limitations of blinding strategies and types of shams that have been used in dry needling trials. DATA SOURCES: Twelve databases were searched from inception to February 2016. STUDY SELECTION: Trials that compared active dry needling with a sham that simulated dry needling were included. DATA EXTRACTION: The main domains of data extraction were participant/therapist details, intervention details, blinding strategies, blinding assessment outcomes, and key conclusions of authors. Reported blinding strategies and sham types were synthesized descriptively, with available blinding effectiveness data synthesized using a chance-corrected measurement of blinding (blinding index). DATA SYNTHESIS: The search identified 4894 individual publications with 27 trials eligible for inclusion. In 22 trials, risk of methodological bias was high or unclear. Across trials, blinding strategies and sham types were heterogeneous. Notably, no trials attempted therapist blinding. Sham protocols have focused on participant blinding using strategies related to group standardization and simulation of tactile sensations. There has been little attention given to the other senses or cognitive strategies to enhance intervention credibility. Nonpenetrating sham types may provide effective participant blinding. LIMITATIONS: Trials were clinically and methodologically diverse, which limited the comparability of blinding effectiveness across trials. Reported blinding evaluations had a high risk of chance findings with power clearly achieved in only 1 trial. CONCLUSIONS: Evidence-based consensus on a sham protocol for dry needling is required. Recommendations provided in this review may be used to develop sham protocols so that future protocols are more consistent and potentially more effective.

Effectiveness and adequacy of blinding in the moderation of pain outcomes: Systematic review and meta-analyses of dry needling trials.

BACKGROUND: Blinding is critical to clinical trials because it allows for separation of specific intervention effects from bias, by equalising all factors between groups except for the proposed mechanism of action. Absent or inadequate blinding in clinical trials has consistently been shown in large meta-analyses to result in overestimation of intervention effects. Blinding in dry needling trials, particularly blinding of participants and therapists, is a practical challenge; therefore, specific effects of dry needling have yet to be determined. Despite this, dry needling is widely used by health practitioners internationally for the treatment of pain. This review presents the first empirical account of the influence of blinding on intervention effect estimates in dry needling trials. The aim of this systematic review was to determine whether participant beliefs about group allocation relative to actual allocation (blinding effectiveness), and/or adequacy of blinding procedures, moderated pain outcomes in dry needling trials. METHODS: Twelve databases (MEDLINE, EMBASE, AMED, Scopus, CINAHL, PEDro, The Cochrane Library, Trove, ProQuest, trial registries) were searched from inception to February 2016. Trials that compared active dry needling with a sham that simulated dry needling were included. Two independent reviewers performed screening, data extraction, and critical appraisal. Available blinding effectiveness data were converted to a blinding index, a quantitative measurement of blinding, and meta-regression was used to investigate the influence of the blinding index on pain. Adequacy of blinding procedures was based on critical appraisal, and subgroup meta-analyses were used to investigate the influence of blinding adequacy on pain. Meta-analytical techniques used inverse-variance random-effects models. RESULTS: The search identified 4,894 individual publications with 24 eligible for inclusion in the quantitative syntheses. In 19 trials risk of methodological bias was high or unclear. Five trials were adequately blinded, and blinding was assessed and sufficiently reported to compute the blinding index in 10 trials. There was no evidence of a moderating effect of blinding index on pain. For short-term and long-term pain assessments pooled effects for inadequately blinded trials were statistically significant in favour of active dry needling, whereas there was no evidence of a difference between active and sham groups for adequately blinded trials. DISCUSSION: The small number and size of included trials meant there was insufficient evidence to conclusively determine if a moderating effect of blinding effectiveness or adequacy existed. However, with the caveats of small sample size, generally unclear risk of bias, statistical heterogeneity, potential publication bias, and the limitations of subgroup analyses, the available evidence suggests that inadequate blinding procedures could lead to exaggerated intervention effects in dry needling trials.

Paucity of evidence for a relationship between long-chain omega-3 fatty acid intake and chronic obstructive pulmonary disease: a systematic review.

CONTEXT: The anti-inflammatory activity of long-chain n-3 polyunsaturated fatty acids (PUFAs) has been established in several chronic inflammatory diseases but has yet to be demonstrated in inflammatory lung diseases such as chronic obstructive pulmonary disease (COPD). OBJECTIVE: The aim of this systematic review was to investigate, using PRISMA guidelines, the relationship between the intake of long-chain n-3 PUFAs and the prevalence, severity, and health outcomes of COPD. DATA SOURCES: Eight health databases and the World Health Organization's international clinical trial registry were searched for relevant studies. STUDY SELECTION: Experimental or observational studies that were published in English and that assessed long-chain n-3 PUFA intake (by determining habitual consumption and/or tissue levels) in adults with COPD were included. DATA EXTRACTION: Publication demographics, participant characteristics, type of intervention or exposure, long-chain n-3 PUFA intake, pulmonary function, COPD mortality, and COPD severity were independently extracted from each article by 2 authors using a prospectively designed data extraction tool. DATA SYNTHESIS: All 11 of the studies included in the review were observational. Approximately equal numbers of studies reported significant (n = 6, 5 inverse) relationships or no significant relationships (n = 5) between either consumption of long-chain n-3 PUFAs or levels of long-chain n-3 PUFAS in tissue and a COPD outcome. CONCLUSIONS: Current evidence of a relationship between long-chain n-3 PUFA intake and COPD is limited and conflicting, with studies having wide methodological variation. REGISTRATION NUMBER: PROSPERO 2013:CRD42013004085.

Feasibility of ω-3 fatty acid supplementation as an adjunct therapy for people with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial.

BACKGROUND: There is evidence to support the use of supplementation with long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) from oily fish or fish oil for the treatment of various inflammatory diseases such as rheumatoid arthritis. Chronic obstructive pulmonary disease (COPD) is a progressive, terminal disease characterized by persistent airflow limitation, lung and systemic inflammation. To date, one randomized controlled trial has been published that assessed the efficacy of LCn-3PUFA in people with this condition. The aim of this article is to discuss the feasibility of conducting a trial to evaluate fish oil supplementation as adjunct therapy in people with COPD. METHODS/DESIGN: A 16-week parallel, double-blind, randomized, placebo-controlled dietary supplementation trial will be evaluated. Forty participants meeting spirometric and clinical criteria for COPD will be recruited from metropolitan Adelaide, South Australia. Participants will be randomized by minimization, based on a score derived from the modified Medical Research Council Scale for breathlessness, to receive 6 g/day of fish oil (approximately 3.6 g/day of LCn-3PUFA), or placebo (6 g/day of corn oil) capsules. Feasibility outcomes (recruitment, retention, supplement adherence, and time lost to exacerbation) and scientific outcomes (effect size and estimates of variance for inflammatory biomarkers, incorporation of LCn-3PUFA into erythrocytes, small airways function, dyspnea and functional exercise capacity) will be assessed pre- and post-intervention. Key feasibility criteria include recruitment of 40 participants in 52 weeks, 75% participant retention rate, 2% increase in the proportion of long-chain omega-3 fatty acids in erythrocytes, and a positive moderate effect size in at least three efficacy measures. DISCUSSION: There are a number of challenges in designing supplementation intervention studies with this population. These include the lack of prior data from which to select appropriate primary outcomes or to estimate effect sizes, and the feasibility of continuous supplementation in a population characterized by multiple comorbidities and a high likelihood of exacerbations, potentially requiring hospitalization or change in medication. Upon completion of this protocol, feasibility outcomes will guide the direction of future multicentre dietary interventions in this population. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000158864.

The active cycle of breathing technique: a systematic review and meta-analysis.

QUESTION: What is the best available research evidence (volume, quality, consistency, generalisability) for the active cycle of breathing technique (ACBT)? DESIGN: Systematic review with meta-analysis. PARTICIPANTS: Participants with respiratory conditions characterised by chronic sputum production. INTERVENTION: The active cycle of breathing or forced expiratory technique. COMPARATOR: All comparators including control conditions. OUTCOME MEASURES: All outcomes providing continuous data. RESULTS: Twenty-four studies were included. Ten comparators were identified with the most common being conventional chest physiotherapy, positive expiratory pressure and a control. The outcomes most frequently assessed were sputum wet weight (n = 17), forced vital capacity (n = 12) and forced expiratory volume in 1 s (n = 12). Meta-analysis was completed on the primary outcome of sputum wet weight. The standardised mean difference (SMD, random effects) showed an increase in sputum wet weight during and up to 1 h post ACBT compared to conventional physiotherapy (SMD 0.32, 95%CI 0.05-0.59), external oscillatory devices (0.75, 0.48-1.02), and control (0.24, 0.02-0.46). CONCLUSION: The overall body of evidence was classified as good (good volume, quality and consistency, excellent generalisability). High level, variable risk of bias research evidence favours ACBT over most alternatives for short-term improvements in secretion clearance.

An internet-based physical activity intervention for adolescents with cerebral palsy: a randomized controlled trial.

AIM: To determine the effectiveness of an 8-week internet-based, lifestyle physical-activity intervention for adolescents with cerebral palsy (CP). METHOD: A randomized controlled trial using concealed allocation with blinded assessments at baseline, 10, and 20 weeks. Forty-one adolescents with CP participated (26 males, 15 females; mean age 13y 7mo, SD 1y 8mo, range 11-17y; Gross Motor Function Classification System levels: I, n=21; II, n=17; III, n=3; unilateral distribution n=16, bilateral n=25). Primary outcome was physical activity (NL-1000 accelerometers and self-report [Multimedia Activity Recall for Children and Adolescents: MARCA]). Secondary outcomes were exercise knowledge (a purpose-designed scale), attitudes, intention and self-efficacy (Lifestyle Education for Activity Program II scales), self-reported sedentary behaviour (MARCA), and functional capacity (6-min walk test). RESULTS: At 10 weeks the intervention group showed no increased physical activity compared with the comparison group (weekly steps: change of +2420 vs -12189 steps p=0.06; weekly moderate-to-vigorous physical activity: change of +70 vs +8min, p=0.06; weekly distance walked: change of +3 vs -9.1km, p=0.05) and exercise knowledge (12% vs 1% improvement, p=0.08). There were no statistically significant differences for these outcomes at 20 weeks, or in self-reported physical activity at 10 or 20 weeks. INTERPRETATION: There was a positive short-term pattern for improvement in physical activity and knowledge. Internet-based programs may offer an alternative for participants unable to attend regular face-to-face physical activity programs.

Short-term effects on outcomes related to the mechanism of intervention and physiological outcomes but insufficient evidence of clinical benefits for breathing control: a systematic review.

QUESTIONS: What is the volume, quality, consistency, and generalisability of the evidence for breathing control? What is the effect on outcomes related to the target and mechanism of breathing control, as well as physiological and clinical outcomes? DESIGN: Systematic review with meta-analysis. PARTICIPANTS: People with chronic respiratory disease, post-surgical, or asymptomatic individuals. INTERVENTION: Breathing control (relaxed basal, diaphragmatic, or abdominal breathing) as the sole intervention. OUTCOME MEASURES: All outcome measures providing continuous data. RESULTS: Twenty studies were included within the meta-analysis. A beneficial effect was found for abdominal movement (SMD 1.36, 95% CI 0.42 to 2.31), diaphragm excursion (SMD 1.39, 95% CI 1.00 to 1.77), respiratory rate (SMD -0.84, 95% CI -1.09 to -0.60), tidal volume (SMD 0.98, 95% CI 0.71 to 1.25), arterial oxygen saturation (SMD 0.63, 95% CI 0.25 to 1.02) and percutaneous oxygen (SMD 1.48, 95% CI 0.85 to 2.11). Breathing control had a detrimental effect on the work of breathing (SMD 1.06, 95% CI 0.52 to 1.60) and dyspnoea (SMD 1.47, 95% CI 0.88 to 2.05). CONCLUSION: When used as a sole intervention, there was a beneficial effect on outcomes related to the mechanism of breathing control as well as on short-term physiological outcomes. In people with severe respiratory disease, breathing control resulted in a detrimental effect on dyspnoea and work of breathing. There was no clear evidence of an effect on ventilation or long-term physiological outcomes related to gas exchange or the energy cost of breathing. Overall, evidence was satisfactory with studies demonstrating poor consistency, good generalisability, and satisfactory volume and quality.