The effectiveness of finger ortheses for the treatment of swan neck deformity in arthritis patients

ISRCTN ISRCTN55287158
DOI https://doi.org/10.1186/ISRCTN55287158
Secondary identifying numbers NL520, NTR564
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

Leiden University Medical Center (LUMC)
Department of Rheumatology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone +31 (0)71 526 3598
Email f.j.van_der_giesen@lumc.nl

Study information

Study designRandomised, controlled, multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleThe effectiveness of finger ortheses for the treatment of swan neck deformity in arthritis patients
Study acronymEFFORT
Study objectivesOval-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) studiedRheumatoid diseases with hand involvement
InterventionA. Intervention with a Silver Ring splint
B. Intervention with a Oval-8 splint
Intervention typeOther
Primary outcome measureDexterity:
1. Hand/finger function domain of the Arthritis Impact Measurements Scales 2.
2. Sequential Occupational Dexterity Assessment score.
Secondary outcome measures1. Motivation
2. Expectations, preferences and acceptability
3. Compliance and costs
Overall study start date01/03/2005
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants50
Total final enrolment50
Key inclusion criteria1. Mobile swanneck deformity on digits two and/or three due to rheumatoid disease
2. Adults
3. Stable disease activity
Key exclusion criteria1. 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 enrolment01/03/2005
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Center (LUMC) (The Netherlands)
Hospital/treatment centre

Department of Rheumatology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website http://www.lumc.nl/english/start_english.html
ROR logo "ROR" https://ror.org/05xvt9f17

Funders

Funder type

Research organisation

Dutch Arthritis Association (Reumafonds) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.