Condition category
Musculoskeletal Diseases
Date applied
23/04/2015
Date assigned
13/05/2015
Last edited
30/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.herts.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/03/2016: Ethics approval information added. 30/12/2015: The overall trial end date has been extended from 29/02/2016 to 31/10/2016 and the recruitment end date has been extended from 31/10/2015 to 30/06/2016.