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Effectiveness of soft tissue manipulation on function and muscle activity of superficial masseter and anterior temporalis in patients with oral Submucous Fibrosis: A study protocol for randomized clinical trial 软组织操作对口腔黏膜下纤维化患者浅咬肌和颞前肌功能和肌肉活动的影响:一项随机临床试验的研究方案
IF 1.1 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-05-03 DOI: 10.1016/j.ijosm.2025.100764
Rohan Kumar Sahu , Preeti Garg , Deepak Gupta , Aditi Popli , Kanu Goyal , Manu Goyal

Background

Oral Submucous Fibrosis (OSMF) is a chronic, disabling disorder of oral cavity primarily marked by limited mouth opening (trismus) and rigid lips, cheeks and pharynx causing dysphagia and a burning sensation in the mouth.

Objective

To compare the efficacy of soft tissue manipulation on function and muscle activity of superficial masseter and anterior temporalis in patients with OSMF.

Material & methods

A total of 12 OSMF participants will be randomized in two groups i.e. Group 1- Soft tissue manipulation and Intralesional injection (STM + II), while Group 2 -Intralesional injection (II) only. Participants will receive one session per week for 6 weeks with the duration of 30–40 min per session. The mouth opening range, pain and muscle function will be assessed at the baseline and 6 weeks from baseline.

Result

Following normality determination appropriate within and between the group analysis will be performed to evaluate statistical significance and effect size and power of intervention will be computed.

Conclusion

This study will evaluate the efficacy of the STM in improving muscle function of superficial masseter and anterior temporalis in patients with OSMF.

Implications for practice

  • This study protocol deals with Oral Submucous Fibrosis (OSMF) patients having trismus more than 3 months, investigating the effectiveness of Soft Tissue Manipulation (STM) on function and muscle activity of superficial masseter and anterior temporalis muscle in patients with OSMF.
  • Very few studies have been conducted on the application of Osteopathic Manipulative Treatment for the management of temporomandibular dysfunctions but there isn't any published literature on this therapy's potential in cases with OSMF.
口腔黏膜下纤维化(OSMF)是一种慢性致残性口腔疾病,主要表现为张嘴受限(牙关),嘴唇、脸颊和咽部僵硬,导致吞咽困难和口腔灼烧感。目的比较软组织手法对OSMF患者浅咬肌和颞前肌功能及肌肉活动的影响。材料,方法12名OSMF参与者将被随机分为两组,即1组-软组织操作和局内注射(STM + II),而2组-局内注射(II)。参与者将在6周内每周接受一次训练,每次训练30-40分钟。将在基线和基线后6周评估张口范围、疼痛和肌肉功能。结果经正态性判定后,进行组内和组间分析,评价统计学显著性,计算干预的效应量和威力。结论本研究将评价STM对OSMF患者浅咬肌和颞前肌功能的改善效果。•本研究方案针对患有牙关超过3个月的口腔黏膜下纤维化(OSMF)患者,研究软组织操作(STM)对OSMF患者浅表咬肌和颞前肌功能和肌肉活动的影响。•很少有研究应用整骨疗法治疗颞下颌功能障碍,但没有任何已发表的文献关于该疗法在OSMF病例中的潜力。
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引用次数: 0
Placebo effects in osteopathy and other manual therapies – What they are and why they matter to clinical practice, education, and research 整骨疗法和其他手工疗法中的安慰剂效应-它们是什么以及为什么它们对临床实践、教育和研究很重要
IF 1.1 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-04-17 DOI: 10.1016/j.ijosm.2025.100762
David Hohenschurz-Schmidt , Torsten Liem
Placebo effects are measurable changes in health outcomes arising from treatment context, driven by learning and expectancy mechanisms. While increasingly well documented and understood, their role in osteopathic and other manual therapies remains underexplored. Given the inherently complex and interpersonal nature of these interventions, understanding placebo and nocebo effects is essential for refining clinical practice, education, and research.
This narrative review synthesises current research on placebo mechanisms and their implications for osteopathic practice, education, and research. A non-systematic literature search was conducted using Google Scholar, structured by pre-defined learning outcomes, and prioritising high-quality studies and systematic reviews where available. Contradictory findings were sought and critically appraised to provide a balanced perspective.
Beginning with a historical overview and up-to-date summary of placebo-related concepts and mechanisms, the review highlights how expectancy, contextual factors, and psychobiological processes contribute to treatment effects in manual therapy. On this basis, the article advocates for a person-centred, biopsychosocial approach that leverages positive expectations while minimising nocebo effects. It also underscores the need for education models that incorporate placebo science to enhance clinical practice. Future research should prioritise well-designed efficacy trials, while also advancing knowledge of how expectancy and learning mechanisms influence treatment outcomes in manual therapies.
安慰剂效应是在学习和预期机制的驱动下,由治疗环境引起的可测量的健康结果变化。虽然越来越多的文献和理解,它们在整骨疗法和其他手工疗法中的作用仍未被充分探索。鉴于这些干预措施固有的复杂性和人际关系性质,了解安慰剂和反安慰剂效应对于改进临床实践、教育和研究至关重要。这篇叙述性综述综合了目前关于安慰剂机制的研究及其对整骨疗法实践、教育和研究的影响。使用谷歌Scholar进行非系统文献检索,该检索由预定义的学习成果构成,并优先考虑可用的高质量研究和系统综述。为了提供一个平衡的观点,我们寻求并批判性地评估了相互矛盾的发现。本文首先回顾了安慰剂相关概念和机制的历史概况和最新总结,重点介绍了预期、环境因素和心理生物学过程如何影响手工疗法的治疗效果。在此基础上,文章提倡以人为本的生物心理社会方法,利用积极的期望,同时最大限度地减少反安慰剂效应。它还强调了需要将安慰剂科学纳入教育模式,以加强临床实践。未来的研究应该优先考虑设计良好的疗效试验,同时也要推进关于期望和学习机制如何影响手工疗法治疗结果的知识。
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引用次数: 0
Is regression in lumbar disk herniation possible by spinal mobilization? A single-blind randomized controlled clinical study 腰椎间盘突出症可以通过脊柱活动恢复吗?一项单盲随机对照临床研究
IF 1.1 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-04-05 DOI: 10.1016/j.ijosm.2025.100760
Burhan Taşkaya , İsmail Taşkent , Mahmut Çakıllı , Öznur Tunca

Aims

This study aims to examine the impacts of spinal mobilization practices on herniation distance, disc height, and facet joint distance, as well as functional status, pain, range of motion (ROM), and flexibility in lumbar disc herniation (LDH) patients.

Methods

Thirty-two participants participated in the study, divided into an Intervention and Control Group. Radiological findings were evaluated by magnetic resonance imaging before and after the study. The Back Performance Scale, Visual Analogue Scale, The S, and The Sit and Reach Test were assessed before, after, and at three months. The control group received ten sessions of stabilization exercises for five weeks, two sessions per week. In the intervention group, spinal mobilization applications were applied in addition to stabilization exercises

Results

Intra-group analysis revealed significant reductions in herniation distance, increases in facet joint distance, pain alleviation, functional improvement, enhanced flexibility, and extended ROM in both groups (p < 0.05). Notably, a significant increase in disc height was observed exclusively in the Intervention Group (p < 0.05). Inter-group analysis revealed no significant differences between the groups post-intervention (p > 0.05).

Conclusion

Mobilization applications applied in LDH patients may have a positive effect on radiological findings, functional status, pain, ROM, and flexibility.

ClinicalTrials.gov Identifier

NCT05753579 (03.02.2023)
目的:本研究旨在探讨脊柱活动训练对腰椎间盘突出症(LDH)患者的突出距离、椎间盘高度、关节突关节距离以及功能状态、疼痛、活动范围(ROM)和柔韧性的影响。方法32例被试分为干预组和对照组。在研究前后通过磁共振成像评估放射学表现。在三个月前、三个月后和三个月时分别对背部表现量表、视觉模拟量表、S量表和坐伸测试进行评估。对照组接受10次稳定训练,为期5周,每周2次。结果组间分析显示,两组患者的突出距离显著减少,关节突关节距离增加,疼痛减轻,功能改善,柔韧性增强,关节活动范围延长(p <;0.05)。值得注意的是,仅在干预组观察到椎间盘高度显著增加(p <;0.05)。组间分析显示干预后各组间无显著差异(p >;0.05)。结论在LDH患者中应用活动应用可能对放射学表现、功能状态、疼痛、ROM和柔韧性有积极影响。
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引用次数: 0
Potential effects of combining osteopathic manual therapy and menstrual awareness on pain and associated symptoms in women with primary dysmenorrhea: A randomized clinical trial 结合整骨疗法和月经意识对原发性痛经女性疼痛及相关症状的潜在影响:一项随机临床试验
IF 1.1 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-04-04 DOI: 10.1016/j.ijosm.2025.100761
María Conesa-Albaladejo , Gemma Victoria Espí-López , Eva Martínez-Graullera , Anna Arnal-Gómez

Background

Dysmenorrhea is a menstrual condition that accounts for 50–90 % of all gynaecological consultations and is the most common gynaecological condition among young women. Lack of information regarding treatment options can affect the symptoms and quality of life of women who suffer from it. Osteopathic manual therapy could be a treatment option to improve symptoms in primary dysmenorrhea.

Objective

The aim of this study was to apply an osteopathic manual therapy protocol to reduce menstrual pain and other symptoms related to primary dysmenorrhea.

Methods

A randomized clinical trial was conducted. Thirty-nine female volunteers diagnosed with primary dysmenorrhea, with a mean age of 30.4 years (SD = 5.67), were randomly assigned to two groups: an experimental group (n = 19) who received body awareness plus osteopathic manual therapy and a comparator group (n = 20) who received only body awareness. Pain intensity (Visual Analogue Scale), pain perception (the McGill Pain Questionnaire), quality of life (36-Item Short Form Survey Instrument), body satisfaction (Body Satisfaction and Global Self-Perception Questionnaire), and overall perception of change (Patient Global Impression of Change Scale) were assessed pre- and post-treatment.

Results

Comparing both groups, the experimental group showed a statistically significant improvement in pain intensity (p = 0.007), pain perception (p = 0.025), quality of life (p < 0.001), and body satisfaction (p < 0.001). In addition, most women in the experimental group (94.7 %) perceived a positive change after treatment, while most of the comparator group (65 %) reported no changes.

Conclusion

An osteopathic manual therapy protocol combined with body awareness revealed significant improvements in terms of pain and other symptoms in women with dysmenorrhea.
痛经是一种月经状况,占所有妇科咨询的50 - 90%,是年轻女性中最常见的妇科状况。缺乏关于治疗选择的信息可能会影响患有该病的妇女的症状和生活质量。整骨疗法可作为改善原发性痛经症状的一种治疗选择。目的:本研究的目的是应用整骨疗法来减轻月经疼痛和其他与原发性痛经相关的症状。方法采用随机临床试验。39名确诊为原发性痛经的女性志愿者,平均年龄30.4岁(SD = 5.67),随机分为两组:实验组(n = 19)接受身体意识加整骨疗法,对照组(n = 20)只接受身体意识疗法。治疗前后分别评估疼痛强度(视觉模拟量表)、疼痛感知(麦吉尔疼痛问卷)、生活质量(36项简短问卷)、身体满意度(身体满意度和整体自我感知问卷)和整体变化感知(患者整体变化印象量表)。结果两组比较,实验组患者疼痛强度(p = 0.007)、疼痛感觉(p = 0.025)、生活质量(p <;0.001),身体满意度(p <;0.001)。此外,实验组中的大多数女性(94.7%)认为治疗后出现了积极的变化,而大多数比较组(65%)报告没有变化。结论结合身体意识的整骨疗法可显著改善痛经患者的疼痛和其他症状。
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引用次数: 0
How to Prepare for the Comprehensive Osteopathic Medical Licensing Examination of the USA level 2-Cognitive Evaluation (COMLEX-USA level 2-CE) 如何准备美国综合骨科医师执业资格考试2级认知评估(complex -USA level 2-CE)
IF 1.1 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-03-11 DOI: 10.1016/j.ijosm.2025.100758
Samuel Kadavakollu, Aaron George, Venkata Atluri, Paula Gregory
To complete undergraduate medical training and secure licensure, osteopathic medical students must pass standardized high-stakes examinations, including the Comprehensive Osteopathic Medical Licensing Examination of the USA Level 2-Cognitive Evaluation (COMLEX-USA Level 2-CE). The examination aims to verify learners' necessary clinical knowledge, diagnostic reasoning, required competencies for osteopathic physicians in training, and readiness before they advance to graduate medical education settings. As the number of students in osteopathic medical training increases, it is essential to advance opportunities for COMLEX-USA Level 2-CE preparation. This manuscript aims to support osteopathic medical students and osteopathic medical educators, learning specialists, academic advisors, and administrators in developing a successful preparation plan for the COMLEX-USA Level 2-CE. The tips within this manuscript align with the information presented in osteopathic medical school curricula and the content outline found within the National Board of Osteopathic Medical Examiners (NBOME) blueprint. These include an emphasis on preparation phases for planning, reviewing, and practicing as well as the importance of clinical curriculum, clinical examinations, NBOME Blueprint, clinical scenarios, and complete full-length examinations. The article is an opinion piece that describes how osteopathic medical students can prepare, practice, and develop more effective board preparation strategies to improve their COMLEX Level 2-CE score.
为了完成本科医学培训并获得执照,骨科医学学生必须通过标准化的高风险考试,包括美国综合骨科医学执照考试2级认知评估(complex -USA Level 2-CE)。考试的目的是验证学习者必要的临床知识、诊断推理、骨科医生在培训中所需的能力,以及他们进入研究生医学教育环境之前的准备。随着骨科医学培训学生人数的增加,为complex - usa 2级ce准备提供机会是至关重要的。该手稿旨在支持骨科医学学生和骨科医学教育工作者,学习专家,学术顾问和管理人员在制定一个成功的complex - usa 2级ce准备计划。本手稿中的提示与骨科医学院课程中提供的信息和国家骨科医学检查委员会(NBOME)蓝图中的内容大纲保持一致。这些包括强调计划、复习和实践的准备阶段,以及临床课程、临床考试、nome蓝图、临床场景和完整的全长考试的重要性。这篇文章是一篇观点文章,描述了骨科医学院的学生如何准备、实践和制定更有效的董事会准备策略,以提高他们的complex 2级ce分数。
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引用次数: 0
Osteopathic manipulative treatment of the ankle-foot complex in individuals with limited dorsiflexion: Study protocol for a randomized crossover clinical trial 有限背屈个体踝足复合体的整骨手法治疗:一项随机交叉临床试验的研究方案
IF 1.1 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-03-09 DOI: 10.1016/j.ijosm.2025.100756
Alice Loures de Paula , Rayane Quintão Castro , Heloisa Costa Souza , Bruna de Castro Moreira , Isabella Cristina Moreira Baião , Cyntia Pace Schmitz Correa , Diogo Carvalho Felício , Diogo Simões Fonseca
Reduced ankle dorsiflexion range of motion leads to changes in daily functional activities such as walking. Myofascial, muscular, and joint techniques are commonly used to restore this range. Joint techniques typically focus on the talocrural joint, treating the foot as a rigid segment. This study aims to propose an evaluation and treatment protocol for the ankle and foot complex in healthy individuals with reduced dorsiflexion. A randomized crossover clinical trial, with a 2-week washout period and follow-up to assess the retention of the intervention's effects, will be conducted in adults aged 18–40 years. Thirty participants will be recruited and assessed before and after intervention for ankle range of motion using the weight-bearing lunge test, as well as for kinematic and spatiotemporal gait variables measured by inertial sensors. The intervention, consisting of osteopathic manipulative treatment, will target the talocrural, distal tibiofibular, subtalar, midtarsal (Chopart), tarsal-metatarsal, and metatarsal-phalangeal joints. This study has been submitted to the Ethics Committee of the Universidade Federal de Juiz de Fora (protocol no. 6.917.725) and registered in the Brazilian Registry of Clinical Trials (RBR-10rvpcp3). An acute improvement in ankle dorsiflexion range of motion is expected, along with additional effects on the spatiotemporal and kinematic gait variables, which could assist in clinical decision-making for treating dorsiflexion limitations.
踝关节背屈活动范围的减少会导致日常功能活动(如行走)的改变。肌筋膜、肌肉和关节技术通常用于恢复这一范围。关节技术通常集中在距骨关节,将脚作为一个刚性节段。本研究旨在提出一个评估和治疗方案的踝关节和足复杂的健康个体减少背屈。将在18-40岁的成年人中进行一项随机交叉临床试验,为期2周的洗脱期和随访,以评估干预效果的保留性。将招募30名参与者,并在干预前后使用负重弓步测试评估踝关节活动范围,以及通过惯性传感器测量的运动学和时空步态变量。干预包括整骨疗法的手法治疗,将针对距骨、胫腓远端、距下、跗骨中关节(Chopart)、跗骨-跖骨关节和跖骨-指骨关节。这项研究已提交给瑞士联邦大学伦理委员会(议定书号:1)。6.917.725),并在巴西临床试验登记处注册(RBR-10rvpcp3)。预计踝关节背屈活动范围的急性改善,以及对时空和运动学步态变量的额外影响,可以帮助临床决策治疗背屈限制。
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引用次数: 0
Lessons learned from the digital transformation of physiotherapy education: A phenomenological study 物理治疗教育数字化转型的经验教训:现象学研究
IF 1.1 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-03-08 DOI: 10.1016/j.ijosm.2025.100759
Laura Eccott , Andrea Moulson , Karen Atkinson , Salvatore Livatino , Jeremy Lewis , Mindy Cairns

Objective

The Covid-19 pandemic changed education globally with a rapid reduction of in-person learning and increase in e-learning. This was challenging for students with themes of poorer motivation, reduced engagement, and difficulty translating knowledge into practical skills. Although Covid-19 restrictions have been removed in the UK, increased e-learning is likely to be permanently integrated in healthcare programmes by most UK universities. Therefore, programmes need to evaluate their e-learning to learn lessons for the future. This study aimed to understand physiotherapy students’ experiences of e-learning and what, if any, specific topics were more challenging and why they felt this was the case to identify how e-learning can be developed to meet their needs.

Methods

A descriptive phenomenological methodology and purposive sampling of physiotherapy students at a UK university was used. Two semi-structured focus groups were conducted, data was analysed using reflexive thematic analysis.

Results

Four themes were constructed which were: connected but disconnected; collaborative disengagement; practicality for professional identity; and disembodiment with anatomy.

Conclusions

For vocational healthcare courses with substantial practical skill development required to meet regulatory standards, the balance of online and in-person learning will continue to be a challenge. The changes to education delivery which occurred because of the Covid-19 pandemic have provided educators with an opportunity to reflect on the challenges facing both students and the profession itself in this increasingly online world. Recommendations from this study include integrating online communication skills within the curriculum, prioritising digital skills, and embracing emerging immersive technologies to enhance anatomy learning.

Implications for educational practice

  • The balance of online and in-person learning for professional healthcare programmes is challenging
  • Curriculums should include development of online communication skills to support students learning experience in the online classroom and to develop the skills required for the future workplace
  • Digital skill development should be integrated into programmes to reflect the changing professional climate of healthcare
  • MSK programmes using online anatomy learning needs to include embodied experiences with sensory-motor activities to support deep learning of the topic, digital tools such as iVR may be appropriate to support this
目的2019冠状病毒病大流行改变了全球教育,现场学习迅速减少,网络学习增加。这对那些动机较差、参与度较低、难以将知识转化为实践技能的学生来说是一个挑战。尽管英国已经取消了对Covid-19的限制,但大多数英国大学可能会将增加的电子学习永久地纳入医疗保健课程。因此,各项目需要评估其电子学习,为未来吸取教训。本研究旨在了解物理治疗学生对电子学习的体验,以及如果有的话,哪些特定的主题更具挑战性,以及为什么他们认为情况是这样,以确定如何开发电子学习以满足他们的需求。方法采用描述性现象学方法,对英国一所大学理疗专业的学生进行有目的的抽样调查。进行了两个半结构化的焦点小组,使用反身性主题分析对数据进行了分析。结果构建了4个主题:连通但不连通;协作脱离;职业认同的实用性;和解剖分离。结论对于需要大量实践技能发展以满足监管标准的职业卫生保健课程,在线和面对面学习的平衡将继续是一个挑战。Covid-19大流行导致的教育提供方式的变化为教育工作者提供了一个机会,让他们反思在这个日益网络化的世界中,学生和职业本身所面临的挑战。该研究的建议包括将在线交流技能纳入课程,优先考虑数字技能,以及采用新兴的沉浸式技术来加强解剖学学习。对教育实践的影响•专业医疗保健课程在线和面对面学习的平衡具有挑战性•课程应包括在线沟通技能的发展,以支持学生在在线课堂上学习经验,并培养未来工作场所所需的技能•数字技能发展应纳入课程,以反映医疗保健专业环境的变化•MSK课程使用在线解剖学学习需要包含感官运动活动的具体体验来支持主题的深度学习,数字工具如iVR可能适合支持这一点
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引用次数: 0
Leadership and capacity building in international osteopathic research: Introducing Strengthening osteopathy leadership and research (SOLAR) program 国际整骨疗法研究的领导和能力建设:介绍加强整骨疗法领导和研究(SOLAR)计划
IF 1.1 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-22 DOI: 10.1016/j.ijosm.2025.100755
Cindy McIntyre , Gopi Anne McLeod , Ana Paula Antunes Ferreira , Francesco Cerritelli , Jerry Draper-Rodi , Jack Feehan , Michael Fleischmann , Kesava Kovanur Sampath , Chantal Morin , Lee Muddle , Niklas Sinderholm Sposato , Oliver P. Thomson , Loïc Treffel , Nicholas Tripodi , Brett Vaughan , Amie Steel , Jon Adams
Research evidence has become the foundation of modern health services. Health professionals rely on sound research to provide safe and effective care for patients, for the development of innovative diagnostic and treatment practices and to develop policies supporting the provision of optimal healthcare. Osteopathy is an established profession with an emerging research evidence base. The Strengthening Osteopathic Leadership and Research (SOLAR) program is a recent international initiative aiming to further build the evidence base and research capacity of the osteopathy profession. The program was developed by The Australian Research Consortium in Complementary and Integrative Medicine (ARCCIM) at the University of Technology Sydney (Sydney, Australia) and funded primarily by Osteopathy Australia, with the support from the Osteopathic Foundation (UK), Osteopaths New Zealand (NZ), Unité Pour l’Ostéopathie (France), and Svenska Osteopatförbundet (Sweden). This paper describes the origins, objectives and features of the SOLAR program and outlines the importance of the program for future research and practice in the osteopathy profession. From its beginnings in 2022, to date, the SOLAR program has been highly successful, producing a substantial collection of concrete research and presentations, while enhancing the Fellows' capacity and confidence as leaders, both in osteopathy and the broader healthcare environment.
研究证据已成为现代卫生服务的基础。卫生专业人员依靠可靠的研究为患者提供安全有效的护理,发展创新的诊断和治疗做法,并制定支持提供最佳医疗保健的政策。整骨疗法是一个成熟的专业与新兴的研究证据基础。加强整骨疗法领导和研究(SOLAR)计划是最近的一项国际倡议,旨在进一步建立整骨疗法专业的证据基础和研究能力。该项目由悉尼科技大学(澳大利亚悉尼)的澳大利亚补充和综合医学研究联盟(ARCCIM)开发,主要由澳大利亚整骨疗法协会资助,并得到了英国整骨疗法基金会、新西兰整骨疗法协会、法国整骨疗法协会和瑞典Svenska Osteopatförbundet的支持。本文描述了SOLAR项目的起源、目标和特点,并概述了该项目对骨科专业未来研究和实践的重要性。从2022年开始至今,SOLAR项目非常成功,产生了大量具体的研究和报告,同时增强了研究员在整骨疗法和更广泛的医疗环境中作为领导者的能力和信心。
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引用次数: 0
A call for improving the internal validity and the reporting of manual therapy trials self-labelled as pragmatic: A methodological review 呼吁提高内部有效性和报告手工治疗试验标榜为实用主义:方法学回顾
IF 1.1 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-08 DOI: 10.1016/j.ijosm.2025.100754
S. Roura , G. Alvarez , D. Hohenschurz-Schmidt , I. Solà , R. Núñez-Cortés , J. Bracchiglione , C. Fernández-Jané , J. Phalip , I. Gich , M. Sitjà-Rabert , G. Urrútia

Objectives

This study provides further data from a review assessing methodological characteristics of pragmatic randomised controlled trials (pRCTs) published in manual therapy (MT). In this second part, we aim to assess the report, the risk of bias (RoB), and the relationship between these items and the pragmatism scores of the self-labelled pRCTs in the MT field.

Study design and setting

We searched MEDLINE and the Cochrane Central Register of Controlled Trials for pRCTs in the MT field from inception to January 2024. Two independent reviewers screened the trials using several CONSORT extensions and assessed them using the Cochrane Risk of Bias tool. We performed a descriptive analysis using frequencies and percentages and a relation analysis between the trials' pragmatism, their reporting, and their RoB.

Results

We included 39 self-labelled MT pRCTs. Compliance with CONSORT items was higher than 70 % in one-third of the included trials (13/39) but varied across items. Performance and detection bias were the main threats to internal validity (we rated 90 %, 35/39, and 77 %; 30/39 of trials at high risk of bias, respectively). Selective reporting bias was unclear in almost half of the sample (46 %; 18/39). No relation was found between the highly pragmatic attitude and good reporting except for CONSORT item 25 (Sources of funding and other support) (p = 0.006). No relation was found between the RoB and the pragmatic attitude of the studies. The percentage of compliance with CONSORT items was higher in the trials with low RoB.

Conclusion

Pragmatic trials in MT have significant methodological limitations, and their reporting is suboptimal. Nonetheless, trials with less risk of bias had higher compliance with CONSORT items.
目的:本研究通过对发表在《手工疗法》(MT)杂志上的实用随机对照试验(prct)的方法学特征进行评估,提供了进一步的数据。在第二部分中,我们的目标是评估报告,偏倚风险(RoB),以及这些项目与MT领域自标记prct的实用主义分数之间的关系。研究设计和设置我们检索了MEDLINE和Cochrane中央对照试验注册库,从开始到2024年1月,检索了MT领域的prct。两名独立审稿人使用几种CONSORT扩展筛选试验,并使用Cochrane偏倚风险工具进行评估。我们使用频率和百分比进行了描述性分析,并分析了试验的实用主义、报告和RoB之间的关系。结果纳入39例自标记MT prct。在三分之一的纳入试验(13/39)中,CONSORT项目的依从性高于70%,但不同项目的依从性不同。绩效和检测偏差是内部效度的主要威胁(我们的评分为90%,35/39和77%;分别为30/39的高偏倚风险试验)。几乎一半的样本(46%;18/39)。除了CONSORT项目25(资金来源和其他支持)外,高度务实的态度与良好的报告之间没有关系(p = 0.006)。在研究中,RoB与语用态度之间没有关系。在低RoB的试验中,CONSORT项目的依从性百分比较高。结论:MT的实用试验在方法学上存在明显的局限性,其报告不够理想。尽管如此,偏倚风险较低的试验对CONSORT项目的依从性较高。
{"title":"A call for improving the internal validity and the reporting of manual therapy trials self-labelled as pragmatic: A methodological review","authors":"S. Roura ,&nbsp;G. Alvarez ,&nbsp;D. Hohenschurz-Schmidt ,&nbsp;I. Solà ,&nbsp;R. Núñez-Cortés ,&nbsp;J. Bracchiglione ,&nbsp;C. Fernández-Jané ,&nbsp;J. Phalip ,&nbsp;I. Gich ,&nbsp;M. Sitjà-Rabert ,&nbsp;G. Urrútia","doi":"10.1016/j.ijosm.2025.100754","DOIUrl":"10.1016/j.ijosm.2025.100754","url":null,"abstract":"<div><h3>Objectives</h3><div>This study provides further data from a review assessing methodological characteristics of pragmatic randomised controlled trials (pRCTs) published in manual therapy (MT). In this second part, we aim to assess the report, the risk of bias (RoB), and the relationship between these items and the pragmatism scores of the self-labelled pRCTs in the MT field.</div></div><div><h3>Study design and setting</h3><div>We searched MEDLINE and the Cochrane Central Register of Controlled Trials for pRCTs in the MT field from inception to January 2024. Two independent reviewers screened the trials using several CONSORT extensions and assessed them using the Cochrane Risk of Bias tool. We performed a descriptive analysis using frequencies and percentages and a relation analysis between the trials' pragmatism, their reporting, and their RoB.</div></div><div><h3>Results</h3><div>We included 39 self-labelled MT pRCTs. Compliance with CONSORT items was higher than 70 % in one-third of the included trials (13/39) but varied across items. Performance and detection bias were the main threats to internal validity (we rated 90 %, 35/39, and 77 %; 30/39 of trials at high risk of bias, respectively). Selective reporting bias was unclear in almost half of the sample (46 %; 18/39). No relation was found between the highly pragmatic attitude and good reporting except for CONSORT item 25 (Sources of funding and other support) (p = 0.006). No relation was found between the RoB and the pragmatic attitude of the studies. The percentage of compliance with CONSORT items was higher in the trials with low RoB.</div></div><div><h3>Conclusion</h3><div>Pragmatic trials in MT have significant methodological limitations, and their reporting is suboptimal. Nonetheless, trials with less risk of bias had higher compliance with CONSORT items.</div></div>","PeriodicalId":51068,"journal":{"name":"International Journal of Osteopathic Medicine","volume":"55 ","pages":"Article 100754"},"PeriodicalIF":1.1,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143422504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Inter-rater and intra-rater reliability of belt-stabilized hand-held dynamometer using make test in lower extremity muscle strength assessment among healthy adults 用make试验评估健康成人下肢肌力时,带式稳定手持式测功机的评分间和评分内可靠性
IF 1.1 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-03 DOI: 10.1016/j.ijosm.2025.100753
Reil Vinard S. Espino , Consuelo Gonzalez-Suarez , Lewis A. Ingram , Ivan Neil B. Gomez , Kris Anthony T. Agarao , Jazzmine Gale Flores , Nicole Bulseco

Background

A significant factor that affects athletic or functional performance in various sports or activities is the weakness in the muscles of the lower extremities. The isokinetic dynamometer (IKD) and the handheld dynamometer (HHD) are two tools available for measuring muscle strength objectively. However, the handheld dynamometer (HHD) - which is convenient, portable, and simple to use, is one of the more popular ways to measure the strength of the lower limb muscles.

Objective

This study aims to assess the inter-rater and intra-rater reliability of the make test conducted with a belt-stabilized HHD for measuring lower extremity muscle strength.

Design

This research adopted an inter-rater and intra-rater reliability study design involving ten healthy adults (six females, four males; mean age = 22.6 ± 2.9 years) from a university community.

Setting

The assessments were conducted in a Sports Science Laboratory.

Methods

A two-way mixed absolute agreement model of intraclass correlation coefficient (ICC) was used to assess inter-rater and intra-rater reliability.

Results

The intra-rater reliability analysis revealed excellent results for most assessors, with an ICC exceeding 0.75; however, two assessors demonstrated moderate reliability (ICC = 0.72–0.73). The inter-rater reliability showed excellent outcomes ranging from ICC = 0.913 to 0.980.

Conclusion

In conclusion, the make test using a belt-stabilized HHD displayed excellent reliability for assessing hip, knee, and ankle muscle strength in the healthy young adult population.
影响各种运动或活动的运动或功能表现的一个重要因素是下肢肌肉无力。等速测功机(IKD)和手持式测功机(HHD)是两种客观测量肌肉力量的工具。然而,手持式测力仪(HHD)——它方便、便携、使用简单,是测量下肢肌肉力量的一种比较流行的方法。目的本研究旨在评估用带稳定式HHD进行的测量下肢肌肉力量的测试的组间和组内可靠性。本研究采用评估者间和评估者内信度研究设计,涉及10名健康成人(6名女性,4名男性;平均年龄= 22.6±2.9岁)。评估在运动科学实验室进行。方法采用类内相关系数(ICC)的双向混合绝对一致模型,对分级间和分级内的信度进行评估。结果评估者的信度分析结果显示,大多数评估者的评估结果都很好,其ICC值超过0.75;然而,两名评估者表现出中等信度(ICC = 0.72-0.73)。评估者间信度在ICC = 0.913 ~ 0.980范围内显示出良好的结果。综上所述,使用皮带稳定HHD的make测试在评估健康年轻成人的髋关节、膝关节和踝关节肌肉力量方面显示出极好的可靠性。
{"title":"Inter-rater and intra-rater reliability of belt-stabilized hand-held dynamometer using make test in lower extremity muscle strength assessment among healthy adults","authors":"Reil Vinard S. Espino ,&nbsp;Consuelo Gonzalez-Suarez ,&nbsp;Lewis A. Ingram ,&nbsp;Ivan Neil B. Gomez ,&nbsp;Kris Anthony T. Agarao ,&nbsp;Jazzmine Gale Flores ,&nbsp;Nicole Bulseco","doi":"10.1016/j.ijosm.2025.100753","DOIUrl":"10.1016/j.ijosm.2025.100753","url":null,"abstract":"<div><h3>Background</h3><div>A significant factor that affects athletic or functional performance in various sports or activities is the weakness in the muscles of the lower extremities. The isokinetic dynamometer (IKD) and the handheld dynamometer (HHD) are two tools available for measuring muscle strength objectively. However, the handheld dynamometer (HHD) - which is convenient, portable, and simple to use, is one of the more popular ways to measure the strength of the lower limb muscles.</div></div><div><h3>Objective</h3><div>This study aims to assess the inter-rater and intra-rater reliability of the make test conducted with a belt-stabilized HHD for measuring lower extremity muscle strength.</div></div><div><h3>Design</h3><div>This research adopted an inter-rater and intra-rater reliability study design involving ten healthy adults (six females, four males; mean age = 22.6 ± 2.9 years) from a university community.</div></div><div><h3>Setting</h3><div>The assessments were conducted in a Sports Science Laboratory.</div></div><div><h3>Methods</h3><div>A two-way mixed absolute agreement model of intraclass correlation coefficient (ICC) was used to assess inter-rater and intra-rater reliability.</div></div><div><h3>Results</h3><div>The intra-rater reliability analysis revealed excellent results for most assessors, with an ICC exceeding 0.75; however, two assessors demonstrated moderate reliability (ICC = 0.72–0.73). The inter-rater reliability showed excellent outcomes ranging from ICC = 0.913 to 0.980.</div></div><div><h3>Conclusion</h3><div>In conclusion, the make test using a belt-stabilized HHD displayed excellent reliability for assessing hip, knee, and ankle muscle strength in the healthy young adult population.</div></div>","PeriodicalId":51068,"journal":{"name":"International Journal of Osteopathic Medicine","volume":"56 ","pages":"Article 100753"},"PeriodicalIF":1.1,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143611010","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
International Journal of Osteopathic Medicine
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