Javier Muñoz Laguna, Emanuela Nyantakyi, Urmila Bhattacharyya, Kathrin Blum, Matteo Delucchi, Felix Karl-Ludwig Klingebiel, Marco Labarile, Andrea Roggo, Manuel Weber, Thomas Radtke, Milo A Puhan, Cesar A Hincapié
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We also assessed whether blinding is feasible among outcome assessors and explored factors influencing perceptions about intervention assignment.</p><p><strong>Methods: </strong>On 7-8 November 2022, 24 participants were randomly allocated (1:1 ratio) to active or control manual interventions of the back. The active group (n = 11) received soft tissue mobilisation of the lumbar spine. The control group (n = 13) received light touch over the thoracic region with deep breathing exercises. The primary outcome was blinding of participants immediately after a one-time intervention session, as measured by the Bang blinding index (Bang BI). Bang BI ranges from -1 (complete opposite perceptions of intervention received) to 1 (complete correct perceptions), with 0 indicating 'random guessing'-balanced 'active' and 'control' perceptions within an intervention arm. Secondary outcomes included blinding of outcome assessors and factors influencing perceptions about intervention assignment among both participants and outcome assessors, explored via thematic analysis.</p><p><strong>Results: </strong>24 participants were analysed following an intention-to-treat approach. 55% of participants in the active manual soft tissue mobilisation group correctly perceived their group assignment beyond chance immediately after intervention (Bang BI: 0.55 [95% confidence interval (CI), 0.25 to 0.84]), and 8% did so in the control group (0.08 [95% CI, -0.37 to 0.53]). Bang BIs in outcome assessors were 0.09 (-0.12 to 0.30) and -0.10 (-0.29 to 0.08) for active and control participants, respectively. Participants and outcome assessors reported varying factors related to their perceptions about intervention assignment.</p><p><strong>Conclusions: </strong>Blinding of participants allocated to an active soft tissue mobilisation of the back was not feasible in this methodological trial, whereas blinding of participants allocated to the control intervention and outcome assessors was adequate. Findings are limited due to imprecision and suboptimal generalisability to clinical settings. 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引用次数: 0
摘要
研究设计：背景：单中心、双平行组、方法学随机对照试验，以评估盲法的可行性：背景：背部徒手疗法干预试验在方法学上面临着盲法可行性和成功率的挑战。我们评估了对背部主动徒手软组织活动疗法和对照疗法进行盲法干预的可行性。我们还评估了盲法在结果评估者中是否可行，并探讨了影响对干预分配看法的因素：2022年11月7-8日，24名参与者被随机分配（1:1比例）到背部主动或对照人工干预中。主动组（n = 11）接受腰椎软组织活动。对照组（n = 13）接受胸部轻触并配合深呼吸练习。主要结果是参与者在一次性干预治疗后立即失明，以 Bang 失明指数（Bang BI）来衡量。Bang BI 的范围从-1（对所接受干预的认知完全相反）到 1（认知完全正确），0 表示 "随机猜测"--在干预组中 "积极 "和 "控制 "认知平衡。次要结果包括结果评估者的盲法以及影响参与者和结果评估者对干预分配看法的因素，通过主题分析进行探讨。积极徒手软组织调动组中有 55% 的参与者在干预后立即正确地认为他们的组别分配超出了偶然性（Bang BI：0.55 [95% 置信区间 (CI)，0.25 至 0.84]），对照组中有 8% 的参与者正确地认为他们的组别分配超出了偶然性（0.08 [95% CI，-0.37 至 0.53]）。积极参与者和对照组参与者结果评估者的 Bang BI 分别为 0.09（-0.12 至 0.30）和-0.10（-0.29 至 0.08）。参与者和结果评估者报告了与他们对干预分配的看法有关的不同因素：在这项方法学试验中，对被分配到背部软组织活动的参与者进行盲法操作是不可行的，而对被分配到对照组干预的参与者和结果评估者进行盲法操作则是充分的。由于不精确和对临床环境的可推广性不理想，研究结果存在局限性。在徒手治疗试验中，有必要对盲法进行仔细思考和考虑：试验注册：ClinicalTrials.gov：试验注册：ClinicalTrials.gov：NCT05822947（回顾性注册）。
Is blinding in studies of manual soft tissue mobilisation of the back possible? A feasibility randomised controlled trial with Swiss graduate students.
Study design: Single-centre, two-parallel group, methodological randomised controlled trial to assess blinding feasibility.
Background: Trials of manual therapy interventions of the back face methodological challenges regarding blinding feasibility and success. We assessed the feasibility of blinding an active manual soft tissue mobilisation and control intervention of the back. We also assessed whether blinding is feasible among outcome assessors and explored factors influencing perceptions about intervention assignment.
Methods: On 7-8 November 2022, 24 participants were randomly allocated (1:1 ratio) to active or control manual interventions of the back. The active group (n = 11) received soft tissue mobilisation of the lumbar spine. The control group (n = 13) received light touch over the thoracic region with deep breathing exercises. The primary outcome was blinding of participants immediately after a one-time intervention session, as measured by the Bang blinding index (Bang BI). Bang BI ranges from -1 (complete opposite perceptions of intervention received) to 1 (complete correct perceptions), with 0 indicating 'random guessing'-balanced 'active' and 'control' perceptions within an intervention arm. Secondary outcomes included blinding of outcome assessors and factors influencing perceptions about intervention assignment among both participants and outcome assessors, explored via thematic analysis.
Results: 24 participants were analysed following an intention-to-treat approach. 55% of participants in the active manual soft tissue mobilisation group correctly perceived their group assignment beyond chance immediately after intervention (Bang BI: 0.55 [95% confidence interval (CI), 0.25 to 0.84]), and 8% did so in the control group (0.08 [95% CI, -0.37 to 0.53]). Bang BIs in outcome assessors were 0.09 (-0.12 to 0.30) and -0.10 (-0.29 to 0.08) for active and control participants, respectively. Participants and outcome assessors reported varying factors related to their perceptions about intervention assignment.
Conclusions: Blinding of participants allocated to an active soft tissue mobilisation of the back was not feasible in this methodological trial, whereas blinding of participants allocated to the control intervention and outcome assessors was adequate. Findings are limited due to imprecision and suboptimal generalisability to clinical settings. Careful thinking and consideration of blinding in manual therapy trials is warranted and needed.
期刊介绍：
Chiropractic & Manual Therapies publishes manuscripts on all aspects of evidence-based information that is clinically relevant to chiropractors, manual therapists and related health care professionals.
Chiropractic & Manual Therapies is an open access journal that aims to provide chiropractors, manual therapists and related health professionals with clinically relevant, evidence-based information. Chiropractic and other manual therapies share a relatively broad diagnostic practice and treatment scope, emphasizing the structure and function of the body''s musculoskeletal framework (especially the spine). The practices of chiropractic and manual therapies are closely associated with treatments including manipulation, which is a key intervention. The range of services provided can also include massage, mobilisation, physical therapies, dry needling, lifestyle and dietary counselling, plus a variety of other associated therapeutic and rehabilitation approaches.
Chiropractic & Manual Therapies continues to serve as a critical resource in this field, and as an open access publication, is more readily available to practitioners, researchers and clinicians worldwide.
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