Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0515103445
Study information
Scientific title
Acronym
Study hypothesis
The small joints of the hands are often involved in the disease process of rheumatoid arthritis (RA) which can lead to pain, loss of function and problems with activities of daily living. This is not only an expense to the individual in terms of emotional costs and loss of work but also to the wider community in terms of the expense of therapy and health care provision. Currently, anecdotal and clinical experience indicate that the use of vaseline in gloves and hot water during active exercises for subjects with RA hands has a beneficial influence on pain and functional ability. Further investigation is therefore required to test this hypothesis. The benefits of such a study might include the inclusion of findings to the existing body of knowledge, the development of guidelines in the management of RA hands, cost-effective implementation of home exercise programmes which are evidence-based.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Musculoskeletal Diseases: Rheumatoid arthritic hand
Intervention
This is an experimental study with a target population of subjects who have clinically diagnosed RA affecting their hands. The independent variable is the heat treatment (vaseline in gloves and hot water 37 degrees C) while the dependent variable will be the measurement tools.
A different-subject design will be used, with subjects (randomly assigned into Group 1- the heat and exercise group or Group 2 - the exercise only group). Range of movement will be measured bilaterally (both hands) of flexion of all fingers in millimetres (mm) from the end of each finger to the first wrist crease (same measurements as used by Dellhag et al (1992)). Grip strength will be measured with a dynamometer (an instrument which the patient holds tightly). Pain or movement will be measured on a 10 point scale and pain without movement on a 100mm visual analogue scale (VAS) (same measurements as used by Dellhag et al (1992)). Stiffness will be measured on a 100mm VAS scale (as per Dellhag et al (1992)). A table will be compiled using the raw data from the study showing before and after measurements. A Mann Whitney U statistical test will be carried out. An related t-test will be used if the sample size is large enough.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Range of movement, grip strength, pain and stiffness measurements which have been justified for use in previous studies and in particular these will mirror the outcome measures used in the Dellhag et al (1992) study.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
24/09/2001
Overall trial end date
31/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. All subjects will 18-70 years old.
2. 24 patients will be recruited from the rheumatology clinic list and randomly assigned into Group 1 or Group 2.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
24
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
24/09/2001
Recruitment end date
31/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Rehabilitation Gym
Harrow
HA1 3UJ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North West London Hospitals NHS Trust (UK), NHS R&D Support Funding
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