Hand OsteoarthritisNCT07708454
Outcomes After First-line Treatment of Hand Osteoarthritis
An observational study of Hand Osteoarthritis, run by Lund University.
Trial summary
This study will investigate outcomes of a 3-month first-line treatment program for hand osteoarthritis, using data from the Swedish Osteoarthritis Registry. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- 3 months of exercise and education
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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 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.
- Conditions
- Hand Osteoarthritis
- Being tested
- 3 months of exercise and education
- Keywords
- Osteoarthritis, First-line treatment, Physical therapy, exercise, education, hand
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 months of exercise and educationOther
| Study group | Role | What they receive |
|---|---|---|
| Hand osteoarthritis | Patients with a clinical diagnosis of hand osteoarthritis participating in a first-line treatment program Receives: Other: 3 months of exercise and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS pain
The NRS comprises an 11-point scale where 0 indicates no pain and 10 indicates the worst possible pain.
Measured: From enrollment to 3 and 12 months follow-up, respectively
Health-related quality of life
Assessed with the EuroQol - 5 dimension descriptive system (EQ-5D-3L)
Measured: From enrollment to 3 and 12 months, respectively
Secondary outcomes (4)
Pain frequency
dichotomous, frequent/rare
Measured: From enrollment to 3 and 12 months follow-up, respectively
Physical activity
Assessed with the Swedish Board of Health and Welfare indicators
Measured: From enrollment to 3 and 12 months follow-up, respectively
Fear of movement
Dichotomous reply, yes/no
Measured: from enrollment to 3 and 12 months follow-up, respectively
Willingness for surgery
Dichotomous reply, yes/no
Measured: From enrollment to 3 and 12 months follow-up, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Jan 2016
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Cronström, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708454
- Sponsor's protocol ID
- Dnr: 2022-06657-01
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD for primary and secondary outcomes will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Patient-reported Outcomes After a 3-month First-line Treatment Program in Men and Women With Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT07708454
- Acronym / sponsor ID
- Dnr: 2022-06657-01
- Conditions
- Hand Osteoarthritis
- Keywords
- Osteoarthritis, First-line treatment, Physical therapy, exercise, education, hand
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate outcomes of a 3-month first-line treatment program for hand osteoarthritis, using data from the Swedish Osteoarthritis Registry.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand osteoarthritis | – | Other: 3 months of exercise and educationPatients with a clinical diagnosis of hand osteoarthritis participating in a first-line treatment program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 months of exercise and education | Other | Hand osteoarthritis |
Primary outcome
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.
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)
4 secondary outcomes
Pain frequency
Time frame: From enrollment to 3 and 12 months follow-up, respectively
Physical activity
Time frame: 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
Willingness for surgery
Time frame: From enrollment to 3 and 12 months follow-up, respectively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD for primary and secondary outcomes will be made available upon reasonable request.
Related trials for Hand Osteoarthritis
Active, not recruiting
Balneotherapy in Hand Osteoarthritis
Hand Osteoarthritis
Active, not recruitingPhase 4
Methotrexate in Erosive Inflammatory Hand Osteoarthritis
Hand Osteoarthritis, Erosive Osteoarthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Active, not recruitingPhase 2
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
Osteoarthritis Hand
RecruitingPhase 2/3
Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments
Erosive Hand Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Cronström, PhD principal investigator
Lund University
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Osteoarthritis, run by Lund University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS pain (time frame: From enrollment to 3 and 12 months follow-up, respectively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.