The effectiveness of finger ortheses for the treatment of swan neck deformity in arthritis patients
| ISRCTN | ISRCTN55287158 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55287158 |
| Protocol serial number | NL520, NTR564 |
| Sponsor | Leiden University Medical Center (LUMC) (The Netherlands) |
| Funder | Dutch Arthritis Association (Reumafonds) (The Netherlands) |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 14/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr F J van der Giesen
Scientific
Scientific
Leiden University Medical Center (LUMC)
Department of Rheumatology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 3598 |
|---|---|
| f.j.van_der_giesen@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The effectiveness of finger ortheses for the treatment of swan neck deformity in arthritis patients |
| Study acronym | EFFORT |
| Study objectives | Oval-8 splints and Silver Ring splints are equally effective in improving dexterity in patients with swan neck deformities in index-and middle finger |
| Ethics approval(s) | Approval received from the Ethics board of Leiden University Medical Center on the 28th February 2005 (ref: P05.011). |
| Health condition(s) or problem(s) studied | Rheumatoid diseases with hand involvement |
| Intervention | A. Intervention with a Silver Ring splint B. Intervention with a Oval-8 splint |
| Intervention type | Other |
| Primary outcome measure(s) |
Dexterity: |
| Key secondary outcome measure(s) |
1. Motivation |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 50 |
| Total final enrolment | 50 |
| Key inclusion criteria | 1. Mobile swanneck deformity on digits two and/or three due to rheumatoid disease 2. Adults 3. Stable disease activity |
| Key exclusion criteria | 1. Not a good understanding of the Dutch language 2. Already using swan neck ortheses 3. Conditions that prohibit the use of ortheses 4. Other diseases with effect on hand function |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | qualitative results | 01/12/2010 | 14/01/2021 | Yes | No |
| Results article | results | 15/08/2009 | 14/01/2021 | Yes | No |
Editorial Notes
14/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
