Condition category
Musculoskeletal Diseases
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
04/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.lumc.nl/english/start_english.html

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

Publication citations

Additional files

Editorial Notes