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临床试验/NCT07708454
NCT07708454已完成不适用

Changes in Patient-reported Outcomes After a 3-month First-line Treatment Program in Men and Women With Hand Osteoarthritis

Lund University0 个研究点目标入组 2,000 人开始时间: 2016年1月1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
入组人数
2,000
主要终点
NRS pain

研究概览

简要总结

This study will investigate outcomes of a 3-month first-line treatment program for hand osteoarthritis, using data from the Swedish Osteoarthritis Registry.

详细描述

According to international guidelines, exercise, education and splinting (if needed) should constitute first-line treatment for people with hand osteoarthritis (OA). However, few studies have investigated the outcomes of such treatment in individuals with hand OA. In this retrospective register-based study the investigators will investigate the outcomes of 3-months participation of first-line treatment for hand OA using data from the Swedish Osteoarthritis register (SOAR). Outcomes will be self-reported change in pain, pain frequency, health-related quality of life, physical activity, fear of movement and willingness for joint surgery between baseline and three months follow-up. In addition, the investigators will investigate if potential improvements remain at 12 months.

Statistical analysis Changes in continuous variables between baseline and the two follow-ups (3 and 12 months) will be analyzed using paired T-test. Changes in proportions in the categorical variables will be analyzed using McNemars test for pairwise comparisons. Standardized effect sizes will be reported as Cohen's d with the following cut offs: 0.2=small, 0.5=medium and 0.8=large effect size. All outcomes will be analyzed separately for females and males.

In this study the investigators will include all participants registered in SOAR fulfilling the eligibility criteria outlined below (n>1000) and consequently no power calculation was performed.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • a clinical diagnosis of hand OA
  • participated for three months in the program
  • reported any of the included outcomes at both baseline and at 3 months follow-up.

排除标准

  • 未提供

研究组 & 干预措施

Hand osteoarthritis

Patients with a clinical diagnosis of hand osteoarthritis participating in a first-line treatment program

干预措施: 3 months of exercise and education (Other)

结局指标

主要结局

NRS pain

时间窗: From enrollment to 3 and 12 months follow-up, respectively

The NRS comprises an 11-point scale where 0 indicates no pain and 10 indicates the worst possible pain.

Health-related quality of life

时间窗: From enrollment to 3 and 12 months, respectively

Assessed with the EuroQol - 5 dimension descriptive system (EQ-5D-3L)

次要结局

  • Pain frequency(From enrollment to 3 and 12 months follow-up, respectively)
  • Physical activity(From enrollment to 3 and 12 months follow-up, respectively)
  • Fear of movement(from enrollment to 3 and 12 months follow-up, respectively)
  • Willingness for surgery(From enrollment to 3 and 12 months follow-up, respectively)

研究者

申办方类型
Other
责任方
Sponsor

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