Extracorporeal Shock Wave Therapy (ESWT) in the management of Decubitus ulceration in complex neurological disabilities

ISRCTN	ISRCTN88965832
DOI	https://doi.org/10.1186/ISRCTN88965832
Protocol serial number	N0204185326
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	Royal Hospital for Neuro-disability, NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Keith Andrews
Scientific

Institute of Neuropalliative Rehabilitation
Royal Hospital for Neuro-disability
West Hill
Putney
London
SW15 3SW
United Kingdom

Phone	+44 020 8780 4534
Email	kandrews@rhn.org.uk

Primary study design	Interventional
Study design	Single blind crossover study
Secondary study design	Randomised controlled trial
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(s)	The primary outcome will be the area of pressure sore healed by the end of one month period.
Key secondary outcome measure(s)	1. Time to heal 50% 2. Time to complete healing 3. Site of ulceration
Completion date	30/09/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

Institute of Neuropalliative Rehabilitation

London
SW15 3SW
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2010		Yes	No