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Completed

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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Key information

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

3 months of exercise and education

Other

Primary outcomes

  1. 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.

  2. 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

  1. Pain frequency

    Time frame: From enrollment to 3 and 12 months follow-up, respectively

    dichotomous, frequent/rare

  2. Physical activity

    Time frame: From enrollment to 3 and 12 months follow-up, respectively

    Assessed with the Swedish Board of Health and Welfare indicators

  3. Fear of movement

    Time frame: from enrollment to 3 and 12 months follow-up, respectively

    Dichotomous reply, yes/no

  4. 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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