Clinical effects of radiofrequency based therapy
| ISRCTN | ISRCTN10995065 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10995065 |
| Secondary identifying numbers | HSK/PG/NHS/00312 |
- Submission date
- 23/04/2015
- Registration date
- 13/05/2015
- Last edited
- 02/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
Physiotherapy, Department of Allied Health Professions and Midwifery
School of Health and Social Work, University of Hertfordshire
College Lane, Hatfield
AL10 9AB
United Kingdom
| Phone | +44 (0)1707 284000 |
|---|---|
| t.watson@herts.ac.uk |
Scientific
44a Grove Road
Luton
LU1 1QJ
United Kingdom
| Phone | +44 (0)7517430077 |
|---|---|
| b.r.kumaran@herts.ac.uk |
Study information
| Study design | Single-centre single-blind prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Clinical effects of 448 KHz capacitive resistive monopolar radiofrequency (CRMRF) based therapy on patients suffering from chronic osteoarthritis of the knee joint |
| Study objectives | 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(s) | NRES Committee North West - Greater Manchester South, 25/06/2015, ref: 15/NW/0529 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/05/2015 |
| Completion date | 31/10/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 45 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/06/2015 |
| Date of final enrolment | 30/06/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
AL7 1BW
United Kingdom
Sponsor information
University/education
Physiotherapy, Department of Allied Health Professions and Midwifery
School of Health and Social Work, University of Hertfordshire
Hatfield
AL10 9AB
England
United Kingdom
| Phone | +44 (0)1707 284000 |
|---|---|
| ask@herts.ac.uk | |
| Website | http://www.herts.ac.uk/ |
"ROR" |
https://ror.org/0267vjk41 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/01/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We aim to publish the results in a leading international journal. |
| IPD sharing plan | Participant level data is subject to commercial embargo, hence the researchers are unable to share it. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2019 | 02/09/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
02/09/2020: Publication reference, total final enrolment number and IPD sharing statement added.
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.
