Clinical effects of radiofrequency based therapy. Version 1.
Research type
Research Study
Full title
Clinical effects of 448 kHz Capacitive Resistive Monopolar Radiofrequency (CRMRF) based therapy on patients suffering from chronic osteoarthritis of the knee joint.
IRAS ID
173691
Contact name
Tim Watson
Contact email
ISRCTN Number
ISRCTN10995065
Duration of Study in the UK
0 years, 4 months, 16 days
Research summary
Does 448 kilohertz radiofrequency based treatment improve pain and functional quality of life in patients suffering from chronic osteoarthritis of the knee joint?
Osteoarthritis (OA) of the knee joint is a common degenerative joint disorder and a major public health problem throughout the world. In physiotherapy OA knee is often treated using devices delivering radiofrequency (RF) energy. The most commonly used is Shortwave Therapy operating at 27.12 Megahertz. However, devices operating at significantly lower frequencies (below 1 Megahertz) are also commercially available claiming to be clinically effective although with limited supporting evidence. Capacitive Resistive Monopolar Radiofrequency (CRMRF) delivered at an operating frequency of 448 kilohertz is one such therapy.
This study aims to investigate the effects of CRMRF therapy (administered using ‘Indiba Activ 902’) on pain and functional quality of life (QoL) of patients suffering from chronic OA knee. The study is fully funded by Indiba S.A., Spain. Suitable participants will be recruited from the concerned department(s) of participating NHS trust hospital. They will then be randomly allocated to one of the three study groups - active, placebo or control. Active group participants will receive CRMRF and current standard care two times a week for four weeks. Placebo group will receive placebo-CRMRF and standard care for the same duration. Control group will receive standard care only. Participants will be assessed for pain and functional QoL before, immediately after, and one and three months following intervention. Each participant will be involved in the study for four months from the start of treatment. The data collected from the groups will be analysed statistically.
The results will identify whether adding CRMRF to the current care provides any 'added value', and additionally whether it provides results better than an equivalent placebo intervention. The study will also provide useful baseline data for further research.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0529
Date of REC Opinion
25 Jun 2015
REC opinion
Further Information Favourable Opinion