Extracorporeal Shock Wave Therapy (ESWT) in the management of Decubitus ulceration in complex neurological disabilities
ISRCTN | ISRCTN88965832 |
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DOI | https://doi.org/10.1186/ISRCTN88965832 |
Secondary identifying numbers | N0204185326 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 08/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Keith Andrews
Scientific
Scientific
Institute of Neuropalliative Rehabilitation
Royal Hospital for Neuro-disability
West Hill
Putney
London
SW15 3SW
United Kingdom
Phone | +44 020 8780 4534 |
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kandrews@rhn.org.uk |
Study information
Study design | Single blind crossover study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | To assess whether ESWT improve the rate of healing of decubitus ulceration in people with complex neurological disabilities. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Skin and Connective Tissue Diseases: Decubitus ulceration |
Intervention | The radiographer will be aware of the treatment (ESWT or placebo) and it is likely that the patient may sense some difference between treatments. The Research Nurse carrying out the measurements will be blind to the treatment. The patient will either receive one dose of Shockwave therapy or placebo each week for four weeks then after two weeks wash out period the other treatment will be delivered, one dose each week for four weeks.. |
Intervention type | Other |
Primary outcome measure | The primary outcome will be the area of pressure sore healed by the end of one month period. |
Secondary outcome measures | 1. Time to heal 50% 2. Time to complete healing 3. Site of ulceration |
Overall study start date | 01/10/2006 |
Completion date | 30/09/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 36 |
Key inclusion criteria | All patients in the Royal Hospital for Neuro-disability with decubitus ulceration who do not have exclusion criteria will be included in the study irrespective of age, level of disability or diagnosis. The total number of patients at the Royal Hospital available for the study is expected to be 36. |
Key exclusion criteria | 1. Those patients who decline to receive treatment after the treatment has been explained to them 2. Those with bleeding disorders or who are on anticoagulant therapy 3. Decubitus ulceration of the chest wall (theoretical risk of lung damage from ESWT) 4. Decubitus ulceration of elbows and elbow creases (uncommon and difficult to access) 5. Ulceration of the ear (uncommon, difficult to access, risk of damage to brain) 6. Over a tumor site |
Date of first enrolment | 01/10/2006 |
Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Neuropalliative Rehabilitation
London
SW15 3SW
United Kingdom
SW15 3SW
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Royal Hospital for Neuro-disability
No information available
NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/03/2010 | Yes | No |