Condition category
Musculoskeletal Diseases
Date applied
28/03/2019
Date assigned
01/05/2019
Last edited
03/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Osteoarthritis of the knee is a common joint condition causing pain, stiffness and weakness around the knee joint. A new device has been developed to reduce pain levels and improve strength in the calf and quadriceps. The aim of the study is to investigate whether a neuromuscular stimulation device can produce an improvement in strength, pain, exercise capacity and health-related quality of life compared to a sham device.

Who can participate?
People with diagnosed knee osteoarthritis who are over the age of 45 and under the age of 85. Due to the use of electrical stimulation, there are some reasons which would stop you being able to take part in the study, these are listed below.
1. Fitted with an electronic implant such as a pacemaker or defibrillator
2. Pregnant
3. Existing or undergoing treatment for Deep Vein Thrombosis
4. Inflammatory arthritis
5. Dermatological conditions affecting the feet or legs
6. Neurological disorder affecting the feet or legs
7. Significant osteoarthritis of the hip, ankle or foot
8. Current or recent knee surgery trauma or injury in the last 3 months
9. Total Knee Replacement
10. Previous corticosteroid or hyaluronic acid injections in the last 6 months
11. Body Mass Index over 40
12. Currently attending physiotherapy
13. Use of TENS
14. Use of Neuromuscular stimulation device or ‘Revitive’ device

What does the study involve?
If you are suitable for the study you will be provided with an activity monitor to wear for 1 week prior to using the device. The following week you will return to the Glenfield Hospital for approximately 2 hours. This will involve measuring muscle strength, exercise tolerance and completing some questionnaires. You will then be randomised into either a group that receives a working device, or a control group that receives a ‘sham’ device. You will use the device once per day for 8 weeks at home, with each session lasting between 30 and 50 minutes. After 4 weeks you will be contacted by a member of the clinical team to find out how you are getting on using the device. After 7 weeks you will be sent an activity monitor to track your activity levels over the final week of the study. After 8 weeks you will be invited to come back to Glenfield Hospital for a third visit where muscle strength and exercise tolerance will again be measured, and the same questionnaires will be completed.

What are the possible benefits and risks of participating?
We do not anticipate any serious risks. The device has been through rigorous testing processes, including previous clinical trials, and has a CE mark for use in patients with osteoarthritis. Activation of the muscles might result in an odd sensation at first but it should not hurt. There are several levels of intensity meaning that the device can be adjusted for your comfort.

We know from previous studies that the Revitive device increases blood flow and alleviates swelling in patients and healthy individuals. We expect it to be of direct benefit to you if you suffer from pain, stiffness and swelling or weakened leg muscles. You will not get paid for participating in this study.

Where is the study run from?
Centre of Exercise and Rehabilitation Sciences, Glenfield Hospital, Groby Road, Leicester, LE3 9QP.

When is the study starting and how long is it expected to run for?
The study begins recruitment in May 2019 and is scheduled to continue until December 2020.

Who is funding the study?
Actegy Ltd

Who is the main contact?
Samuel Briggs-Price
Samuel.briggs-price@uhl-tr.nhs.uk

Trial website

N/A

Contact information

Type

Scientific

Primary contact

Mr Samuel Briggs-Price

ORCID ID

http://orcid.org/0000-0001-7435-3173

Contact details

Biomedical Research Centre - Respiratory
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
01162502758
samuel.briggs-price@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

5

Study information

Scientific title

Using electrical Stimulation of the calf and thigh to treat Knee Osteoarthritis for Pain, function and strEngth: a randomised controlled trial

Acronym

SKOPE

Study hypothesis

1. Patients training with an electrical stimulation device for 8 weeks will have a reduction in pain and an improvement in strength compared to a sham device
2. Patients training with an electrical stimulation device for 8 weeks will show improvements in quality of life measures and functional performance compared to a sham device

Ethics approval

Approved 22/02/2017, North West- Preston Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ; nrescommittee.northwest-preston@nhs.net; 0207 104 8234), ref: 17/NW/0081.

Study design

Single-centre randomised control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Osteoarthritis of the knee

Intervention

Participants are randomised by a computer-generated system to one of two groups:
1. Revitive device
2. Sham device
This will be a blinded study, therefore, participants will not know which device they will receive until the end of the study. The assessor will also be unaware of this.

The Revitive device is an electrical stimulation device comprising of a foot plate and gel pad electrodes. Muscular contraction is stimulated in the calf through the footplate and in the quadriceps by placing the gel pads on the skin. The intensity of stimulation is controlled through a remote by the participant. The sham device will be identical including the remote control, although the device will provide insufficient stimulation to achieve muscular contraction.

The participants will require three visits to the hospital in total. The first visit will provide further information for the study, obtain consent, provide activity tracker and collect medical and demographic details. On the second visit participants will perform strength testing, functional tests and questionnaires. They will also be randomized to the device or sham device on the second visit, this will be performed by another researcher through sealedenvelopes.com. The footplate will be used daily for 30 minutes. The quadriceps electrodes will be used 5 times a week for 20 minutes. A participant diary will be kept to log intensity and frequency of use. After 7 weeks the participants will be sent an activity tracker to wear during the final week. After 8 weeks the initial measures will be repeated and this will conclude the visit schedule. Those on the sham treatment will be offered the real device.

Intervention type

Device

Phase

Not Specified

Drug names

Primary outcome measure

Osteoarthritis is measured using The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at week 1 and week 8.

Secondary outcome measures

1. Health-related quality of life is measured via the Oxford Knee Score, EQ-5D, SF-36 and Pittsburgh sleep quality index at week 1 and week 8.
2. Functional performance is measured via the incremental shuttle walk (ISWT), endurance shuttle walk (ESWT)and the short performance physical battery (SPPB) at week 1 and week 8.
3. Muscle strength will be measured by means of isokinetic dynamometer at week 1 and week 8.
4. Swelling will be measured through joint line circumferences of the knee and ankle at week 1 and week 8.
5. Pain at rest and during movement will be measured using the visual analogue scale (VAS) at week 1 and week 8.
6. Physical activity will be measured using accelerometers worn around the waist at week 0 and week 7.

Overall trial start date

01/01/2017

Overall trial end date

01/01/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. OA diagnosed clinically in accordance with NICE guidance.
2. Aged 45-85 years.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

125

Participant exclusion criteria

1. Fitted with an electronic implant such as a pacemaker or defibrillator.
2. Pregnant.
3. Existing or undergoing treatment for DVT.
4. Significantly impaired cognitive ability.
5. Inflammatory arthritis.
6. Dermatological conditions affecting the feet or legs.
7. Neurological disorder affecting the feet or legs.
8. Significant osteoarthritis of the hip, ankle or foot.
9. Current or recent knee surgery, trauma or injury (last 3 months).
10. Previous corticosteroid or hyaluronic acid injections (last 6 months).
11. BMI over 40.
12. Use of transcutaneous electrical stimulation.
13. Use of neuromuscular electrical stimulation device.

Recruitment start date

20/05/2019

Recruitment end date

01/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glenfield Hospital, University Hospitals of Leicester,
Groby Road
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

Actegy Ltd

Sponsor details

Cain Road
REFLEX
Bracknell
RG12 1HL
United Kingdom
07940 820 622
roseanna.penny@actegy.com

Sponsor type

Industry

Website

https://revitive.com/

Funders

Funder type

Industry

Funder name

Actegy Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer review journal and disseminated at conferences in 2021. The results of the study will be shared with the patient once recruitment has completed.

IPD sharing statement: the datasets generated and/or analysed during the current study will be included in the subsequent results publication.

Intention to publish date

01/01/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/05/2019: Internal review. 03/04/2019: Trial's existence confirmed by the Health Research Authority.