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 design	Randomised, controlled, multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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	Dexterity: 1. Hand/finger function domain of the Arthritis Impact Measurements Scales 2. 2. Sequential Occupational Dexterity Assessment score.
Secondary outcome measures	1. Motivation 2. Expectations, preferences and acceptability 3. Compliance and costs
Overall study start date	01/03/2005
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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.