CompletedNot SpecifiedInterventional

Electrical Stimulation treating knee osteoarthritis for pain, function and strength

Osteoarthritis is a common condition that leads to pain, swelling, and stiffness in the knee joint. Over time, leg muscles around the knee can weaken, making moving around even harder. Researchers at Glenfield Hospital in Leicester are testing a home-use electrical stimulation machine to see if it helps. The device sends gentle electrical pulses to the calf and thigh muscles. The goal is to see if regular use builds muscle strength, reduces knee pain, and helps people walk more comfortably. Participants aged 45 to 85 will be randomly chosen to receive either a working machine or an identical dummy device. You use the device at home once a day for 8 weeks. Taking part also involves wearing an activity tracker, attending two hospital visits for simple strength and walking checks, and filling in follow-up questionnaires.

At a glance

Status

Completed

Phase

Not Specified

Sponsor

Actegy Ltd

Enrolment target

193

Start

20 May 2019

Estimated completion

30 May 2022

Osteoarthritis of the knee

What is this study about?

Knee osteoarthritis happens when the protective cartilage inside the joint wears down over time. This often causes daily ache, swelling, stiffness, and weakness in the thigh and calf muscles. When these muscles become weak, the knee joint absorbs more stress, which can make everyday tasks like walking or climbing stairs painful and tiring.

This clinical trial is studying whether a specialized machine called a neuromuscular stimulation device can help. The device sends mild, safe electrical pulses into the leg muscles to make them gently squeeze and relax. Researchers want to know if using this device at home can rebuild muscle strength, improve blood flow, and ease joint pain without needing extra medication.

To prove whether the machine really works, the trial is 'sham-controlled'. This means half of the participants will be given a working device, and half will receive a dummy machine that looks the same but does not deliver the muscle-strengthening pulses. Comparing the two groups allows doctors to see the true physical benefits of the treatment.

Key takeaways

Tests an at-home electrical stimulation device to improve knee osteoarthritis pain and strength.
Open to adults aged 45 to 85 with clinically diagnosed knee osteoarthritis.
Requires using the machine at home once a day for 30 to 50 minutes over an 8-week period.
Includes two check-up appointments at Glenfield Hospital in Leicester.
Participants have an equal chance of receiving either the active device or a dummy comparison device.

Who may be eligible?

This study is open to adults aged between 45 and 85 who have an official diagnosis of knee osteoarthritis, are able to walk, and can give their own consent.

Because the device uses electrical signals, certain people cannot safely take part. You cannot join if you have an electrical implant (such as a heart pacemaker or defibrillator), are pregnant, or have a history of blood clots (deep vein thrombosis). You are also unable to take part if you have nerve problems or skin conditions affecting your legs or feet, or if you have severe arthritis in your hips, ankles, or feet.

Additionally, you will not be eligible if you have had knee surgery or a serious knee injury in the last three months, a joint replacement in the study knee, or steroid or lubricating injections in the knee within the last six months. People with a body mass index (BMI) of 40 or higher, those currently seeing an NHS physiotherapist, or those already using electrical stimulation machines at home are also excluded.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 45 and 85 years old?
Do you have a doctor's diagnosis of osteoarthritis in your knee?
Are you free of electronic implants, such as a heart pacemaker?
Have you gone at least six months without knee injections and three months without knee surgery?
Can you travel to Glenfield Hospital in Leicester for two appointments?

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts around 16 weeks in total and involves two hospital visits alongside home-based activities. At the start, you will wear a simple activity tracker on your body for one week to record your normal movement. You will then visit Glenfield Hospital in Leicester for about two hours. During this visit, staff will measure your leg muscle strength, test your walking capacity, and ask you to fill in health questionnaires.

You will then be given either a real or dummy machine to take home. You will use it once every day for eight weeks, with each session lasting between 30 and 50 minutes. At week four, a researcher will phone you to check how you are getting on. During week seven, you will wear the activity monitor again for seven days. At week eight, you will return to the hospital for a second visit to repeat the strength tests and questionnaires. Finally, eight weeks after your last hospital visit, you will receive one last health questionnaire in the post to complete at home.

Potential risks and benefits

The stimulation device has been thoroughly tested and certified safe for people with osteoarthritis. It may cause a tingling or slightly unusual twitching feeling in your muscles, but it should not cause pain, and the power level can be adjusted so you stay comfortable. You might experience benefits such as reduced knee pain, less joint stiffness, and stronger leg muscles, though these improvements cannot be guaranteed. You are free to leave the trial at any time without giving a reason, and your regular NHS medical care will not be affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Glenfield Hospital, University Hospitals of Leicester,
City only
Leicester, England

Common questions

Does the electrical stimulation hurt?

No, it should not hurt. You will likely feel a tingling sensation or gentle pulsing as your muscles squeeze, but you can turn the strength setting up or down to keep it completely comfortable.

What is a sham device?

A sham device is an inactive machine designed to look and feel like the real thing. It acts as a comparison dummy so researchers can be sure any improvements are truly caused by the muscle stimulation.

Will I be paid to take part in this trial?

No, participants do not receive payment for taking part in this study.

Can I carry on taking my normal joint medications?

In most cases, yes. However, you should discuss all current pain relief and arthritis medications with the trial team so they can keep accurate records.

Where do the study visits take place?

The hospital assessments take place at the Centre of Exercise and Rehabilitation Sciences at Glenfield Hospital in Leicester.

How to find out more

Samuel Briggs-Price

samuel.briggs-price@uhl-tr.nhs.uk 1162502758 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.