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临床试验/NCT05499559
NCT05499559已完成不适用

Digitally Delivered Education and Exercises for Patients With Hand Osteoarthritis-An Observational Study

Joint Academy2 个研究点 分布在 1 个国家目标入组 846 人开始时间: 2021年7月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
846
试验地点
2
主要终点
Change in Pain Intensity (Numerical Rating Scale NRS, Discrete Boxes 0-10, Higher Score Mean Worse Pain)

研究概览

简要总结

The purpose of this study is to evaluate the effect of a 12 week digital treatment program for patients with hand osteoarthritis. The treatment consisted of exercises and educational sessions with respect to the disease, its natural course and recommended treatment strategies.

Design: An observational longitudinal cohort study.

The investigators will include participants who participated in the digital treatment of Joint Academy® for 3 months.

Outcomes: Investigators will analyze pain with Numeric Rating Scale (NRS) 0-10 (best to worst), function with the Functional Index for Hand OsteoArthritis (FIHOA) and health related quality of life with EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) at baseline and at 3 months. Main outcome will be change in pain. The investigators will also analyze minimally clinical important changes (improved or not) and mean changes in EQ-5D-5L index score, pain and function.

详细描述

Osteoarthritis (OA) is one of the leading causes of disability worldwide and due to its rising prevalence, the identification of appropriate care and care delivery modalities is a priority for the health care systems. Exercise and education constitute the first-line intervention for people with knee, hip and hand OA and have been shown to be effective regardless of symptoms and disease severity. International guidelines recommend that first-line interventions for the majority of musculoskeletal conditions should involve nonsurgical management with exercise and education guided by a physiotherapist (PT) and based on a personalised care approach.

OA of the hand is probably the most common form of OA and almost 50% of women and 25% of men will be affected during the life course. Self-management strategies includes a wide range of strategies such as education for strengthening or stretching exercises, joint protection education for activity and pacing, use of proper body mechanics, and assistive devices to improve pain, reduce inflammation, lower additional risk of deformities, and enhance performance. Systematic reviews that compared joint protection strategies to usual care have shown similar effects at short-term and superior effects at mid- and long-term compared to usual care.

To implement the guidelines, the Better Management of Patients with OsteoArthritis (BOA), a face-to-face concept including education and an option to exercise, has been developed and is offered at primary care clinics in Sweden since 2008 for patients with hip- knee- and hand OA. BOA has previously been found to reduce pain and improve function and quality of life in patients with hip and knee OA. Unfortunately, there is a discrepancy between recommended treatment and what patients receive and around 30% of people with OA seeking care go through first line management.

Traditional face-to-face interventions present barriers, such as limited access and lack of flexibility, which may limit the patients' adherence with the interventions. Digital delivery of the management program may be one way of overcoming such barriers. Telehealth, defined as the 'delivery of healthcare at a distance using information and communication technology' could be a solution to many access barriers and has been rapidly adopted by many healthcare professions and accelerating even more throughout the COVID-19 pandemic.

Literature investigating the use of telehealth for the management of musculoskeletal pain is growing. Systematic reviews have demonstrated that telehealth can provide improvements in pain, physical function and disability that are similar to that of usual face-to-face care for individuals with musculoskeletal conditions such as osteoarthritis for the knee and hip. The use of telehealth also seems to increase exercise adherence for a variety of musculoskeletal conditions. To our knowledge, digital self-management programs for OA of the hand have not yet been evaluated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 18 years (often much older)
  • Previous physical examination regarding hand symptoms
  • Long-lasting hand pain where osteoarthritis is suspected l(for example joint-specific load and/or rest pain, impaired function with stiffness, decreased grip strength, clumsiness, bone roughening of joints).
  • started the treatment between 2022-XX-XX to 2022-XX-XX

排除标准

  • Pregnancy
  • Tendon disease (trigger finger, tendinopathy)
  • Nerve entrapment
  • Arthritis
  • Acute injuries (fracture and/or distortion)

研究组 & 干预措施

Joint Academy

The participants receive the digital treatment of Joint Academy.

干预措施: Joint Academy digital treatment (Behavioral)

结局指标

主要结局

Change in Pain Intensity (Numerical Rating Scale NRS, Discrete Boxes 0-10, Higher Score Mean Worse Pain)

时间窗: Change in pain intensity from baseline to 3 months of treatment.

Pain intensity was assessed using the Numerical Rating Scale (NRS, discrete boxes 0-10) with the instruction: "Mark on this scale how much pain you had in your hand over the past week." The NRS ranged from 0, representing no pain, to 10, representing the maximum pain imaginable. A higher score indicated greater pain intensity. Participants completed mandatory self-assessment questionnaires at baseline and again at 3 months of treatment. All responses were self-reported and entered directly via the digital program interface.

次要结局

  • Functional Index for Hand OsteoArthritis (FIHOA 0 - 30 Higher Score Means Worse Outcome)(Change of Functional Index for Hand OsteoArthritis-score between baseline to 3 months of treatment)

研究者

发起方
Joint Academy
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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