- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07708454
Outcomes After First-line Treatment of Hand Osteoarthritis
Changes in Patient-reported Outcomes After a 3-month First-line Treatment Program in Men and Women With Hand Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hand osteoarthritis
Patients with a clinical diagnosis of hand osteoarthritis participating in a first-line treatment program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to 3 and 12 months follow-up, respectively
|
|
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)
|
From enrollment to 3 and 12 months, respectively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain frequency
Time Frame: From enrollment to 3 and 12 months follow-up, respectively
|
dichotomous, frequent/rare
|
From enrollment to 3 and 12 months follow-up, respectively
|
|
Physical activity
Time Frame: From enrollment to 3 and 12 months follow-up, respectively
|
Assessed with the Swedish Board of Health and Welfare indicators
|
From enrollment to 3 and 12 months follow-up, respectively
|
|
Fear of movement
Time Frame: from enrollment to 3 and 12 months follow-up, respectively
|
Dichotomous reply, yes/no
|
from enrollment to 3 and 12 months follow-up, respectively
|
|
Willingness for surgery
Time Frame: From enrollment to 3 and 12 months follow-up, respectively
|
Dichotomous reply, yes/no
|
From enrollment to 3 and 12 months follow-up, respectively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Cronström, PhD, Lund University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr: 2022-06657-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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