An investigation of the Immediate Effects of Physiotherapy Treatment of the Rheumatoid Arthritic Hand

ISRCTN ISRCTN34847373
DOI https://doi.org/10.1186/ISRCTN34847373
Secondary identifying numbers N0515103445
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
08/04/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Christina Scorringe
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMusculoskeletal Diseases: Rheumatoid arthritic hand
InterventionThis 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 typeOther
Primary outcome measureRange 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 measuresNot provided at time of registration
Overall study start date24/09/2001
Completion date31/03/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexNot Specified
Target number of participants24
Key inclusion criteria1. 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.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment24/09/2001
Date of final enrolment31/03/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Rehabilitation Gym
Harrow
HA1 3UJ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North West London Hospitals NHS Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan