Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students: a Blinding Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Blinding feasibility of participants, measured by the Bang blinding index.
研究概览
简要总结
There is marked uncertainty regarding the feasibility of achieving adequate blinding in randomized controlled trials of manual therapy. In other words, whether participants and outcome assessors can accurately perceive randomly assigned interventions is unclear. This feasibility trial was conducted as part of a doctoral epidemiology course at the University of Zurich, Switzerland. Within the practice-based context of the class and using a study population of healthy graduate students enrolled in the course, the investigators aimed to evaluate blinding of participants randomly assigned (similar to tossing a coin) to one of two manual therapy interventions (active versus control). The investigators also aimed to assess blinding among outcome assessors.
详细描述
Manual therapy remains a guideline-compliant, first-line therapeutic option for back pain. Yet, maintaining methodological quality in randomized controlled trials of manual therapy interventions poses challenges, particularly concerning: (a) The design of adequate 'sham' controls and (b) the blinding status of participants and outcome assessors. Optimal implementation of large-scale manual therapy trials requires testing the feasibility of control manual therapy interventions and effective blinding of participants and outcome assessors. Even when conducted in healthy populations and non-clinical settings, blinding feasibility trials remain an opportunity for methodological advancement in the field of manual medicine, and a research priority for unbiased treatment effect estimation in future trials.
The primary objective of this methodological trial was to quantitatively assess blinding feasibility among participants (graduate students enrolled in an epidemiology Ph.D. course) assigned to an active or control intervention immediately after a one-time intervention session. The secondary objective was to assess blinding feasibility among outcome assessors and explore factors influencing perceptions about intervention assignment among participants and outcome assessors. These two objectives contributed to obtaining valuable preliminary measures of blinding (blinding indices) for a future methodological blinding feasibility trial to be carried out in a real-world clinical setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Blinding was the primary outcome of interest. That said, except for intervention providers, every role was, by protocol, blinded to intervention assignment.
To maintain blinding of participants, candidate participants were formally invited to participate by email, with a study information form that masked the blinding feasibility objective.
The intervention providers were kept in a separate room and could not be blinded but were asked not to disclose the intervention group or the nature of the control MT component to participants, outcome assessors, data analysts, and other members of the study team.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •enrolled in a doctoral-level epidemiology course at the University of Zurich, Switzerland.
排除标准
- •serious pathology (i.e., cancer, severe scoliosis, inflammatory disease, infection, cauda equina syndrome or progressive motor deficit)
- •history of spine surgery
- •obvious contraindication to manual therapy (i.e., spinal fracture)
研究组 & 干预措施
Active manual therapy
Active manual therapy intervention involved mobilization of the lumbar paraspinal musculature. With participants laying prone on a chiropractic table, the intervention provider administered hand-reinforced circumferential movements to six focal areas, using continuous ischemic compression strokes, and adjusting the pressure to participants' tolerability.
干预措施: Active manual therapy (Other)
Control manual therapy
Control MT intervention included light touch to six distal, broad areas of the thoracic region, with a synchronized breathing exercise.
干预措施: Control manual therapy (Other)
结局指标
主要结局
Blinding feasibility of participants, measured by the Bang blinding index.
时间窗: Immediately after the one-time intervention session (study day 1).
The Bang blinding index ranges from -1 to 1, with 0 representing satisfactory blinding. It can be interpreted as the proportion of participants correctly answering their allocated intervention within an intervention arm beyond chance. For the Bang BI, a score with an absolute value of ≤0.3 (i.e., -0.3 to 0.3) was deemed compatible with satisfactory blinding, although blinding scenarios (comparing blinding indices in active vs. control arms) were discussed. Participants were asked: "To which extent do you know which intervention you received?" and were given five possible answers: "I strongly believe I received the active intervention", "I somewhat believe I received the active intervention", "I somewhat believe I received the control intervention", "I strongly believe I received the control intervention", and "I do not know \[whether I received the active or control intervention\]".
次要结局
- Blinding feasibility of outcome assessors, measured by the Bang blinding index.(Immediately after the one-time intervention session (study day 1).)
- Blinding feasibility of outcome assessors, measured by the James blinding index.(Immediately after the one-time intervention session (study day 1).)
- Blinding feasibility of participants, measured by the James blinding index.(Immediately after the one-time intervention session (study day 1).)
- Factors contributing to perceived intervention arm allocation among study participants.(Immediately after the one-time intervention session (study day 1).)
- Factors contributing to perceived intervention arm allocation among outcome assessors.(Immediately after the one-time intervention session (study day 1).)
研究者
Cesar A Hincapié, DC PhD
Senior Scientist and Head of Musculoskeletal Epidemiology Research
Balgrist University Hospital