Condition category
Musculoskeletal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
08/04/2014
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

Mrs Christina Scorringe

ORCID ID

Contact details

Rehabilitation Gym
North West London Hospitals NHS Trust
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes