Contact information
Type
Scientific
Primary contact
Dr F J van der Giesen
ORCID ID
Contact details
Leiden University Medical Center (LUMC)
Department of Rheumatology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 3598
f.j.van_der_giesen@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
EFFORT
Study hypothesis
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
Approval received from the Ethics board of Leiden University Medical Center on the 28th February 2005 (ref: P05.011).
Study design
Randomised, controlled, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Rheumatoid diseases with hand involvement
Intervention
A. Intervention with a Silver Ring splint
B. Intervention with a Oval-8 splint
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/03/2005
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Mobile swanneck deformity on digits two and/or three due to rheumatoid disease
2. Adults
3. Stable disease activity
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
50
Participant 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
Recruitment start date
01/03/2005
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Center (LUMC) (The Netherlands)
Sponsor details
Department of Rheumatology
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Dutch Arthritis Association (Reumafonds) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary