Overcoming placebo-related challenges in manual therapy trials: The ‘whats and hows’ and the ‘touch equality assumption’ proposals

D’Alessandro, Giandomenico; Ruffini, Nuria; Iacopini, Alessio; Annoni, Marco; Kossowsky, Joe; Cerritelli, Francesco

doi:10.1016/j.ijosm.2021.10.003

Cited by 5 publications

(5 citation statements)

References 60 publications

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“…Sham controls are generally difficult to implement in manual therapy trials. Specifically, blinding is frequently compromised because the actual and sham treatments are not indistinguishable [93][94][95][96]. In this pilot study, there were both similarities and dissimilarities between the interventions.…”

Section: Methodological Limitationsmentioning

confidence: 85%

Does Osteopathic Heart-Focused Palpation Modify Heart Rate Variability in Stressed Participants with Musculoskeletal Pain? A Randomised Controlled Pilot Study

Liem,

Bohlen,

Jung

et al. 2024

Healthcare

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Heart rate variability (HRV) describes fluctuations in time intervals between heartbeats and reflects autonomic activity. HRV is reduced in stressed patients with musculoskeletal pain and improved after osteopathic manipulative treatment and mind–body interventions. Heart-focused palpation (HFP) combines manual and mind–body approaches to facilitate relaxation. This randomised controlled pilot study investigated the feasibility and sample size for a future randomised controlled trial and the effect of a single treatment with HFP or sham HFP (SHAM) on short-term HRV. A total of Thirty-three adults (47.7 ± 13.5 years old) with stress and musculoskeletal pain completed the trial with acceptable rates of recruitment (8.25 subjects per site/month), retention (100%), adherence (100%), and adverse events (0%). HFP (n = 18), but not SHAM (n = 15), significantly increased the root mean square of successive RR interval differences (p = 0.036), standard deviation of the NN intervals (p = 0.009), and ratio of the low-frequency to high-frequency power band (p = 0.026). HFP and SHAM significantly decreased the heart rate (p < 0.001, p = 0.009) but not the stress index and ratio of the Poincaré plot standard deviation along and perpendicular to the line of identity (p > 0.05). A power analysis calculated 72 participants. Taken together, the study was feasible and HFP improved HRV in stressed subjects with musculoskeletal pain, suggesting a parasympathetic effect.

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Section: Methodological Limitationsmentioning

confidence: 85%

Does Osteopathic Heart-Focused Palpation Modify Heart Rate Variability in Stressed Participants with Musculoskeletal Pain? A Randomised Controlled Pilot Study

Liem,

Bohlen,

Jung

et al. 2024

Healthcare

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show abstract

“…Despite the abundance of literature on the subject [ 20 , 59 , 60 , 61 , 62 ], the controls in the examined studies are frequently inadequately described, particularly for the manual placebo (or so-called “sham therapy”). When described, control procedures are not always set according to the literature-derived gold standard.…”

Section: Discussionmentioning

confidence: 99%

“…The form was filled in for bibliographic information on the included studies, study aims and design, methods and setting of recruitment, inclusion/exclusion criteria, informed consent, conflict of interest and funding, type of intervention and control, number of participants, characteristics at the baseline, setting of intervention, type of outcome and time points for assessment, results, and adverse events. The osteopathic intervention and the manual sham therapy were analysed following the “whats, hows and how-not-tos” descriptive principle [ 20 ] and the equality assumption (EA) between interventions was assessed. Data were reported by considering the role and use of SD in the assessment, treatment and time frame of the osteopathic treatment.…”

Section: Methodsmentioning

confidence: 99%

The Role of Osteopathic Care in Gynaecology and Obstetrics: An Updated Systematic Review

et al. 2022

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Background: Many efforts are made to find safer and more feasible therapeutic strategies to improve gynaecological care. Non-pharmacological treatments, such as osteopathic interventions, could be used as complementary strategies to better manage different gynaecological conditions. This review aims to report the effectiveness of osteopathic treatment in the gynaecology and obstetrics field, updating the previous review published in 2016. The secondary aim was to elucidate the role of somatic dysfunction (SD) in osteopathic assessment and treatment procedures, as well as their health and economic implications. Methods: An electronic search was conducted in the following databases: Embase, MEDLINE (PubMed), and Science direct. All types of clinical studies published between May 2014 and December 2021 have been included: randomised controlled trial (RCT), controlled before/after, interrupted time series quasi RCT, case controls, case reports, case series, observational, clinical studies involving any type of osteopathic treatment, (standardised, semi-standardised or patients’ need-based treatment) performed alone or in combination with other treatments, were included). Results: A total of 76,750 were identified through database searching and other sources. After the removal of duplicates, 47,655 papers were screened based on title and abstract. A total of 131 full-text articles were consequently assessed for eligibility. Twenty-one new articles were included in the synthesis. A total of 2632 participants with a mean age of 28.9 ± 10.5 years were included in the review. Conclusions: Results showed an effectiveness of osteopathic care in gynaecology and obstetrics, but the studies were too heterogeneous to perform quantitative analysis and make clinical recommendations. Nevertheless, osteopathic care could be considered a safe complementary approach to traditional gynaecological care.

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“…9 Although control interventions are a central feature of efficacy trials, existing guidance for control intervention design focuses on individual therapies, such as psychotherapy, 10 behavioural interventions, 11 rehabilitation, 12 sports and exercise, 13 physiotherapy, 14 and manual therapy. 15 These guidelines provide no quality checklist and few generalisable principles; moreover, they often disregard problems of intervention complexity. 9 Consequently, various specialties follow different approaches to fundamental questions of control intervention design, such as how closely the control should resemble the study intervention.…”

Section: Control Interventions (Often Calledmentioning

confidence: 99%

“…In a pluralistic framework of complex intervention research (such as the 2021 Medical Research Council guidance for complex intervention development and evaluation), efficacy trials complement research designs that are more implementation-focused 9. Although control interventions are a central feature of efficacy trials, existing guidance for control intervention design focuses on individual therapies, such as psychotherapy,10 behavioural interventions,11 rehabilitation,12 sports and exercise,13 physiotherapy,14 and manual therapy 15. These guidelines provide no quality checklist and few generalisable principles; moreover, they often disregard problems of intervention complexity 9.…”

mentioning

confidence: 99%

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

Hohenschurz-Schmidt

Vase

Scott

et al. 2023

BMJ

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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.

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Overcoming placebo-related challenges in manual therapy trials: The ‘whats and hows’ and the ‘touch equality assumption’ proposals

Cited by 5 publications

References 60 publications

Does Osteopathic Heart-Focused Palpation Modify Heart Rate Variability in Stressed Participants with Musculoskeletal Pain? A Randomised Controlled Pilot Study

Does Osteopathic Heart-Focused Palpation Modify Heart Rate Variability in Stressed Participants with Musculoskeletal Pain? A Randomised Controlled Pilot Study

The Role of Osteopathic Care in Gynaecology and Obstetrics: An Updated Systematic Review

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

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