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
Scientific
Rehabilitation Gym
North West London Hospitals NHS Trust
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 24/09/2001 |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Not Specified |
| Target number of participants | 24 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 24/09/2001 |
| Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Rehabilitation Gym
Harrow
HA1 3UJ
United Kingdom
HA1 3UJ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
