NCT Number: NCT07708454
Outcomes After First-line Treatment of Hand Osteoarthritis
This study will investigate outcomes of a 3-month first-line treatment program for hand osteoarthritis, using data from the Swedish Osteoarthritis Registry.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
About this study
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 we 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, we 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 we will include all participants registered in SOAR fulfilling the eligibility criteria outlined below (n>1000) and consequently no power calculation was performed.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 1) a clinical diagnosis of hand OA, 2) Participated for three months in the program 3) reported any of the included outcomes at both baseline and at 3 months follow-up.
Exclusion criteria
None
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Treatment and study plan
Primary outcomes
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NRS pain
Time frame: 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.
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Health-related quality of life
Time frame: From enrollment to 3 and 12 months, respectively
Assessed with the EuroQol - 5 dimension descriptive system (EQ-5D-3L)
Secondary outcomes
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Pain frequency
Time frame: From enrollment to 3 and 12 months follow-up, respectively
dichotomous, frequent/rare
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Physical activity
Time frame: From enrollment to 3 and 12 months follow-up, respectively
Assessed with the Swedish Board of Health and Welfare indicators
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Fear of movement
Time frame: from enrollment to 3 and 12 months follow-up, respectively
Dichotomous reply, yes/no
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Willingness for surgery
Time frame: From enrollment to 3 and 12 months follow-up, respectively
Dichotomous reply, yes/no
Sponsors and collaborators
Lead sponsor
Lund University
Other
Registry information
Official study title
Changes in Patient-reported Outcomes After a 3-month First-line Treatment Program in Men and Women With Hand Osteoarthritis
Important dates
- Study start
- 2016
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Jul 16, 2026
- Registry last updated
- Jul 16, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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