A Pilot Study on App-based Treatment Combining Physical Exercise, Graded Activity, and Pain Journaling for Patients with Spinal Complaints
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- The primary outcome is qualitative information on the viability, feasibility, effectiveness, and safety.
研究概览
简要总结
Background: The prevalence of spinal complaints such as low back pain is rising due to factors like aging, sedentary lifestyle, and obesity. Traditional conservative treatments include physical therapy and lifestyle modifications. The digital revolution in healthcare has introduced app-based interventions as a promising alternative.
Rationale: Given the high burden of spinal complaints and the associated economic impact, there is need for effective and efficient treatment modalities. This is especially evident in Western healthcare systems with growing demands and limited resources due to the changing demographic of the population. An app-based approach offers a viable solution by combining evidence-based conservative treatments. Moreover, an app-based treatment could offer personalized treatment, real-time feedback, and enhanced patient engagement at lower costs, presents as a viable solution.
Objective: This pilot study aims to evaluate the efficacy of an app-based treatment method combining physical exercise, graded activity, and pain journaling for patients with spinal complaints who will otherwise receive physical therapy, general lifestyle advice, or an expectant treatment in current practice.
Study design: Single center prospective study.
Study population: A total of 30 patients over 18 years old suffering from spinal complaints for which in current practice physical therapy, general lifestyle advice, or an expectant treatment will be advised.
Intervention: An app-based treatment consisting of a combination of physical exercise, graded activity, and pain journaling.
Main study parameters/endpoints: Primary endpoint: Patients' experience and satisfaction qualitatively, measured using semi-structured face-to-face interviews after three months of treatment.
Secondary endpoints: Quality of Life (Qol) measured with the EuroQol 5 dimensions (EQ-5D-5L) at baseline, one, two and three months after starting the intervention. Change in back- and leg-pain, measured with the Visual Analogue Scale (VAS). Change in disability, measured with the Oswestry Disability Index (ODI). Change in catastrophizing of pain, measured with the Pain Catastrophizing Scale (PCS). Change in lost productivity, measured with patient reported missed working days. Healthcare consumption, measured with number of visits to doctor or paramedic. Change in Body Mass Index, measured using patients' input on length and weight. Adherence of participants measured using frequency of patients' input in the mobile application. Safety measured using the (serious) adverse events ((S)AE).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The nature and extent of the burden associated with participation in the app-based treatment program primarily involve adherence to recommended activities and inputting relevant health data. Given that the investigators are integrating existing treatment modalities, such as physical exercise, graded activity, and pain journaling, the risks associated with participation are minimal, as these interventions are already deemed safe and widely practiced. The responsibility for determining each patient's suitability for participation in this study lies with the referring physician. Participants can expect benefits such as improved pain management, enhanced physical function, and better overall well-being.
详细描述
- INTRODUCTION AND RATIONALE
The incidence of spinal complaints is increasing in the ageing population. Back pain is amongst the conditions with the highest burden of disease in terms of years lived with disability (YLD), with a global lifetime prevalence of about 80%. The global prevalence of spine-related complaints is 9.4%, and this increases with age, reaching 19-23% by the age of 80. Besides age, spine-related disorders are also associated with a sedentary lifestyle and obesity. Consequently, as the population ages and rates of obesity and physical inactivity increase, the number of patients with spine-related disorders is rising exponentially. Besides causing significant pain and impairment, spinal complaints also impose an economic burden on healthcare systems worldwide. This economic burden is reflected by considerable healthcare-related costs and indirect costs such as loss of productivity.
Traditional conservative interventions, such as physical therapy, pharmacological management, and lifestyle modifications are the most widely used modes of treatment for most spinal complaints, mainly back pain. It should be noted that there is conflicting evidence on the effect of most of these treatments, although there might be evidence for their effectiveness in the short term. It is apparent that physical therapy and lifestyle modifications focused on physical activity are the most successful options to achieve long term results.
The digital revolution in the healthcare sector, characterized by rapid proliferation of health apps, offers promising avenues for innovative treatment modalities. These app-based interventions have potential to deliver personalized treatment regimens, provide real-time feedback, and enhance patient engagement, from the convenience of a patient's mobile device. Another possible benefit of app-based treatments is the wide availability and scalability at relatively low costs, especially when compared to traditional treatments.
While these digital tools hold promise, there remains a critical need to assess their efficacy. Studies of healthcare apps in other fields have shown mixed results, with most indicating promising outcomes from app-based interventions, while some suggest only small benefits, like traditional treatment modalities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients visiting the spine-centre at Zuyderland Medical Centre.
- •Suffering from spinal complaints for which in current practice physical therapy, general lifestyle advice, or an expectant treatment would be advised.
- •Minimum age of 18 years.
- •Psychosocially, mentally, and physically able to fully comply with this study protocol.
- •Informed consent prior to this study.
排除标准
- •Requiring a specific intervention (e.g., surgery, pain treatment, rehabilitation, bracing)
- •Inadequate command of the Dutch language.
- •Digitally illiterate or otherwise unable to use an application on a mobile phone.
- •Active spinal infection.
- •Immature bone (ongoing growth).
- •Active malignancy.
- •Pregnancy.
结局指标
主要结局
The primary outcome is qualitative information on the viability, feasibility, effectiveness, and safety.
时间窗: 3 months
The data used is gathered by evaluating the patients' experience and satisfaction qualitatively, using semi-structured face-to-face interviews at three months follow-up.
次要结局
- Secondary outcome, BMI(3 months)
- Secondary outcome, Quality of Life(3 months)
- Secondary outcome, pain(3 months)
- Secondary outcome, disablity(3 months)
- Secondary outcome, productivity(3 months)
- Secondary outcome, healthcare consumption(3 months)
- Secondary outcome, adherence(3 months)
- Secondary outcome, safety(3 months)