Plain English Summary
Background and study aims
Osteoarthritis (OA), the most common type of arthritis, is a condition that causes joints to become painful and stiff. OA typically affects the knees, hips and small joints of the hands. OA is an incurable, long term condition but there are a number of ways to improve symptoms, such as maintaining a healthy weight and regularly exercising. Unfortunately, OA of the knee can often result in disability and make it hard for people to carry out their normal daily activities. It can also make it difficult for people to exercise. Physiotherapists can help people put together an exercise plan to manage their symptoms. They can also provide various treatments to reduce pain and swelling in the joints, such as radiofrequency (RF) therapy. RF therapy generates heat in the tissues of the affected area, which increases blood flow and relieves pain and inflammation. The standard RF therapy given to patients is shortwave therapy, which delivers a 27.12 Megahertz frequency to the affected joint. There are various types of devices available, including ones that operate at very low frequencies (below 1 Megahertz), although it is not clear how well they actually work. Capacitive Resistive Monopolar Radiofrequency (CRMRF) (448 Kilohertz) is one such low frequency device. The aim of this study is to see how well CRMRF therapy works to relieve pain and improve quality of life in patients suffering from chronic OA of the knee compared to standard therapy. CRMRF will be delivered using the Indiba Activ 902 device.
Who can participate?
Adults diagnosed with OA of the knee.
What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 (intervention group) receive CRMRF therapy alongside standard RF therapy. Those in group 2 (placebo group) receive ‘dummy’ CRMRF therapy alongside standard RF therapy. Those in group 3 (control group) receive standard care only. All participants receive treatment twice a week for four weeks. Participants are assessed for pain and quality of life using questionnaires before, immediately after, and one and three months following treatment. Participants take part in the study for a total of four months.
What are the possible benefits and risks of participating?
The results will help identify whether adding CRMRF to the current care provides any 'added value', and also whether it provides better results than an equivalent placebo treatment. The study will also provide useful data for further research.
Where is the study run from?
Hertfordshire Community NHS Trust (UK)
When is the study starting and how long is it expected to run for?
May 2015 to February 2016
Who is funding the study?
INDIBA SA (Spain)
Who is the main contact?
1. Prof T Watson (public)
t.watson@herts.ac.uk
2. Mr B Kumaran (scientific)
b.r.kumaran@herts.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Mr Tim Watson
ORCID ID
Contact details
Physiotherapy
Department of Allied Health Professions and Midwifery
School of Health and Social Work
University of Hertfordshire
College Lane
Hatfield
AL10 9AB
United Kingdom
+44 (0)1707 284000
t.watson@herts.ac.uk
Type
Scientific
Additional contact
Mr Binoy Kumaran
ORCID ID
Contact details
44a Grove Road
Luton
LU1 1QJ
United Kingdom
+44 (0)7517430077
b.r.kumaran@herts.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HSK/PG/NHS/00312
Study information
Scientific title
Clinical effects of 448 KHz capacitive resistive monopolar radiofrequency (CRMRF) based therapy on patients suffering from chronic osteoarthritis of the knee joint
Acronym
Study hypothesis
The capacitive resistive monopolar radiofrequency (CRMRF) therapy has a statistically and clinically significant benefit over current standard care as well as a placebo-CRMRF intervention in terms of patient and clinical outcomes among patients suffering from chronic osteoarthritis of the knee joint.
Ethics approval
NRES Committee North West - Greater Manchester South, 25/06/2015, ref: 15/NW/0529
Study design
Single-centre single-blind prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Osteoarthritis (OA) of the knee joint
Intervention
1. Group A (treatment): CRMRF therapy + current standard treatment twice a week for 4 weeks
2. Group B (placebo): CRMRF therapy + current standard treatment twice a week for 4 weeks
3. Group C (control): current standard treatment only
Intervention type
Device
Phase
Drug names
Primary outcome measure
Assessed at baseline, immediately after treatment, then again 1 and 3 months following intervention:
1. Visual Analogue Scale (VAS) for pain
2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for functional quality of life (QoL)
Secondary outcome measures
1. Knee joint range of motion
2. 'Timed up and go' test
3. Skin temperature (physiological)
4. Skin blood flow (physiological)
5. Muscle blood flow (physiological)
Overall trial start date
01/05/2015
Overall trial end date
31/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Clinical and radiological diagnosis of OA knee
2. Pain and symptoms in the knee for at least three months
3. Over 18 years of age
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Significant underlying medical conditions
2. OA of other joints such as hip or ankle
3. Currently receiving/received (in the last six months) treatment (including invasive procedures) other than standard care
4. Inability to consent
Recruitment start date
15/06/2015
Recruitment end date
30/06/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hertfordshire Community NHS Trust
Welwyn Garden City
AL7 1BW
United Kingdom
Sponsor information
Organisation
University of Hertfordshire
Sponsor details
Physiotherapy
Department of Allied Health Professions and Midwifery
School of Health and Social Work
University of Hertfordshire
Hatfield
AL10 9AB
United Kingdom
+44 (0)1707 284000
ask@herts.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
INDIBA SA (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We aim to publish the results in a leading international journal.
Intention to publish date
31/01/2017
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list