Outcomes After First-line Treatment of Hand Osteoarthritis

July 13, 2026 updated by: Lund University

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

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

2000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hand osteoarthritis registered in the Swedish Osteoarthritis register. The Swedish Osteoarthritis register is a national quality register evaluating the effect of first-line treatment on osteoarthritis-related outcomes.

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

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Anna Cronström, PhD, Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified IPD for primary and secondary outcomes will be made available upon reasonable request.

IPD Sharing Access Criteria

The data used in this study contains sensitive information about the study participants and they did not provide consent for public data sharing. The current approval by the Regional Ethical Review Board, Sweden does not include data sharing. A minimal data set could be shared by request from a qualified academic investigator for the sole purpose of replicating the present study, provided the data transfer is in agreement with EU legislation on the general data protection regulation and approval by the Swedish Ethical Review Authority.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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