Feasibility of Blinding Spinal Manual Therapy Interventions for a Trial Assessing Management of Primary Care Patients With Back Pain: the SALuBRITY Blinding Feasibility Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Participant blinding success, as measured by the validated Bang blinding index, immediately after intervention session 1.
研究概览
简要总结
This study aims to compare two different spinal manual therapy interventions of the back to determine if they are viable and acceptable for a future study investigating the treatment of patients with back pain. The two proposed spinal manual therapy interventions are widely used in the fields of chiropractic, physical therapy, osteopathy, and manual medicine to treat back pain and improve function. This is a randomized study, meaning that participants are randomly assigned (like tossing a coin) to one of two manual spinal therapy interventions.
详细描述
Clinical trials of spinal manual therapy interventions for back pain and back-related leg pain face methodological challenges regarding the design of effective sham control ('control' hereafter) and blinding of the assigned interventions. Although the assessment of blinding is often neglected in the field of manual medicine, the implementation of high-quality trials of spinal manual therapy interventions warrants formal evaluation of blinding feasibility among participants and outcome assessors to advance randomized clinical trial methods and design.
The objectives of this blinding feasibility trial are:
- To assess the feasibility of blinding participants, with or without experience of spinal manual therapy or current low back pain, randomly allocated to an active or control spinal manual therapy intervention protocol.
- To assess the feasibility of blinding managing clinicians (non-treating clinicians or outcome assessors) within the randomised trial context.
- To examine the impact of spinal manual therapy experience in the past 3 months (Yes vs No) and presence of low back pain during the past four weeks (average intensity ≤2 versus ≥3 out of 10) on the feasibility of participant and managing clinician blinding.
- To explore factors contributing to participant and managing clinician perceptions about the assigned intervention (active versus control) using a qualitative thematic analysis.
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
Participants, managing clinicians, outcome assessors, data analysts, and investigators will be blinded to intervention assigned. Only treating clinicians will not be blinded to the interventions but will be trained and asked not to disclose the intervention, nature of the interventions, nor trial objectives to trial participants or other members of the trial 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
- •Aged 18 years or older
- •With or without experience of spinal manual therapy
- •With or without experience of current low back pain
排除标准
- •Serious spinal pathology (e.g. spinal fracture, cancer or infection)
- •History of lumbar spine surgery
- •Currently under care or in consultation with a specialist, chiropractor, physiotherapist, or osteopath for current back pain
- •Manual medicine health care provider (i.e., chiropractor, physiotherapist, osteopath, massage therapist, manual medicine trained physician)
- •Have a serious comorbidity preventing them from attending the research clinic and receiving the interventions
- •Pregnant or breastfeeding status
- •Involved in pending litigation related to back pain
- •Already participating in another research study related to back pain
研究组 & 干预措施
Active spinal manual therapy protocol
(1) Side-lying lumbar spine manipulation, (2) prone lumbar spine mobilization, and (3) prone thoracic spine manipulation.
干预措施: Active spinal manual therapy protocol (Procedure)
Control spinal manual therapy protocol
(1) Control side-lying lumbar spine manipulation, (2) control prone lumbar spine mobilization, and (3) control prone thoracic spine manipulation.
干预措施: Control spinal manual therapy protocol (Procedure)
结局指标
主要结局
Participant blinding success, as measured by the validated Bang blinding index, immediately after intervention session 1.
时间窗: Immediately after intervention session 1 (study day 1)
The blinding assessment survey item will ask: "Which treatment do you believe you received?" with five response options provided: "Strongly believe I received the genuine treatment," "Somewhat believe I received the genuine treatment," "Somewhat believe I received the control treatment," "Strongly believe I received the control treatment," and "I do not know which treatment I received." Bang BI estimates (between -1 to +1, with 0 indicating satisfactory blinding) can be interpreted as the proportion of correct guesses beyond chance within an intervention arm. For the Bang BI, a score with an absolute value of ≤0.3 (i.e., -0.3 to 0.3) will be deemed compatible with satisfactory blinding, and blinding scenarios will be discussed.
Participant blinding success, as measured by the validated Bang blinding index, immediately after intervention session 2.
时间窗: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
The blinding assessment survey item will ask: "Which treatment do you believe you received?" with five response options provided: "Strongly believe I received the genuine treatment," "Somewhat believe I received the genuine treatment," "Somewhat believe I received the control treatment," "Strongly believe I received the control treatment," and "I do not know which treatment I received." Bang BI estimates (between -1 to +1, with 0 indicating satisfactory blinding) can be interpreted as the proportion of correct guesses beyond chance within an intervention arm. For the Bang BI, a score with an absolute value of ≤0.3 (i.e., -0.3 to 0.3) will be deemed compatible with satisfactory blinding, and blinding scenarios will be discussed.
次要结局
- Participant blinding success, as measured by the validated James blinding index, immediately after intervention session 1.(Immediately after intervention session 1 (study day 1))
- Outcome assessor blinding success, as measured by the validated James index, immediately after intervention session 1.(Immediately after intervention session 1 (study day 1))
- Participant blinding success, as measured by the validated James blinding index, immediately after intervention session 2.(Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1))
- Outcome assessor blinding success, as measured by the validated Bang index, immediately after intervention session 1.(Immediately after intervention session 1 (study day 1))
- Outcome assessor blinding success, as measured by the validated James index, immediately after intervention session 2.(Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1))
- Outcome assessor blinding success, as measured by the validated Bang index, immediately after intervention session 2.(Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1))
研究者
Cesar A Hincapié, DC PhD
Senior Scientist and Head of Musculoskeletal Epidemiology Research
Balgrist University Hospital