ASSERT 2 Database (Version 1)
Research type
Research Database
Full title
Assessment of Effectiveness of Extracorporeal Shock Wave Therapy (ESWT
IRAS ID
149102
Contact name
Nicola Maffulli
Contact email
Research summary
ASSERT 2 Database (Version 1)
REC name
London - South East Research Ethics Committee
REC reference
14/LO/0383
Date of REC Opinion
17 Apr 2014
REC opinion
Further Information Favourable Opinion
Data collection arrangements
The database will capture:
• Diagnosis
• Area to be treated/condition
• Date of symptoms
• Smoke(d). If stopped, date when stopped
• Date of treatment of ESWT and centre
• Prior treatments
• Side treated
• ESWT machine used
• Baseline score, 3,6,12 and 24 month post treatment evaluation using validated scoring systems according to condition and VAS for pain
• Satisfaction
• Complications
• Surgery Yes/No
• Further treatment plan e.g. eccentric exercises
Potential data subjects attending for consultation for ESWT with clinicians (who are authorised to be part of ASSERT 2) will be approached and given the opportunity to participate in ASSERT 2. The recruiting clinician or member of staff within the department will provide an information sheet explaining ASSERT 2 and explain what being involved in ASSERT entails. There will be no additional procedures or burdens to participants as this is an online database for which data is collected at baseline (when the participant would be seeing the clinician for consultation for ESWT treatment). All future follow-up data will be obtained from participants by the ASSERT 2 team via telephone, post or email.Research programme
The ASSERT 2 database will generate information on the number of people with painful conditions affecting the tendons and soft tissues in the UK and globally. It will give: the numbers of men and women who are affected; the age; duration of symptoms of the painful conditions; previous treatments undertaken; if the shockwave therapy has worked or not; length of time needed for the treatment to work; number of people who resort to surgery. The above information will be of use to the people who say what healthcare services people can use, health insurance companies, clinicians, researchers with an interest in conditions affecting tendons and soft tissues and patients with the conditions. To ensure everyone is able to benefit from the ASSERT 2 database and to help to improve knowledge so as to improve people’s health, the data from ASSERT 2 will be available to the research community in the following ways: • Anonymised data will be displayed on the ASSERT website/meetings, conference booklets, clinicians own anonymized data, private and NHS clinics where the conditions are reviewed, international shockwave therapy conferences and specialist meetings such as the British Orthopaedic Association (BOA), BOFAS (British Orthopaedic Foot and Ankle Society).
Research database title
ASSERT 2 Database (Version 1)
Establishment organisation
Curis Consulting Ltd
Establishment organisation address
35 The Avenue
Branksome Park
Poole, Dorset
BH13 6LJ