All studies
Not yet recruitingNAINTERVENTIONAL

Compex SP8.0 - Symptomatic Treatment of Musculoskeletal Pain

This study is about a device called Compex SP8.0, which uses gentle electrical pulses (like TENS) to help manage muscle and joint pain. The main goal is to see how safe and effective the device is when people use it at home for their pain. The results will also help the company make even better wireless pain relief devices in the future. Participants will use the Compex SP8.0 for up to four weeks. They'll record their pain levels before and after using the device to see if it helps. The study aims to understand if this device can really make a difference for people living with ongoing muscle and joint pain, whether it’s a sharp pain or more long-term nerve-related discomfort.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
DJO UK Ltd
Enrolment target
74
Start
01 Feb 2025
Estimated completion
01 Sep 2025

What is this study about?

This study is investigating a device called Compex SP8.0, which is designed to help people manage ongoing muscle and joint pain. This type of pain is often called musculoskeletal pain. The device works by sending gentle electrical pulses, similar to a therapy called TENS (Transcutaneous Electrical Nerve Stimulation), to the affected area. The main purpose of this study is to carefully check if the Compex SP8.0 is safe to use and if it effectively reduces pain when used according to its instructions. The findings of this study will also be important for developing and improving future versions of these pain relief devices.

Participants in the study will use the Compex SP8.0 at home for up to four weeks. They will be taught how to use the device correctly and will have a guide to help them. During this time, they will keep track of their pain levels using a simple rating scale, both before and immediately after each treatment session. This helps the researchers understand how well the device is working to manage pain.

The study is interested in how the device helps different types of musculoskeletal pain, whether it's the kind of pain from an injury or more ongoing nerve-related pain. By collecting information on pain levels, how satisfied people are with the device, and how often they use it, the study hopes to show how useful the Compex SP8.0 can be for daily pain management.

Key takeaways

  • This study uses the Compex SP8.0 device to manage muscle and joint pain.
  • It aims to check if the device is safe and effective for pain relief.
  • Participants will use the device at home for up to four weeks.
  • Pain levels will be tracked using an electronic diary and clinic visits.
  • The study helps develop future pain relief technologies.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and currently have muscle or joint pain that you rate as 4 or higher on a scale of 0 to 10 (where 0 is no pain and 10 is the worst pain imaginable). A doctor will decide if you’re suitable to use the Compex SP8.0 device safely at home for up to four weeks and if you can easily understand how to use it.

There are certain situations where you wouldn't be able to join. For example, if you are pregnant, have certain electronic medical devices like a pacemaker, or if you have skin problems where the device's pads would go. If you are already using another electrical pain relief device or acupuncture, you also wouldn't be able to participate. It's important that you can read and understand the device's instructions and safety information.

If you're interested, the study team will carefully check all these points to make sure the study is right and safe for you.

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.

  1. Are you 18 years old or older?
  2. Do you have ongoing muscle or joint pain that you rate as 4 or higher out of 10?
  3. Are you able to comfortably read and understand instructions for a medical device?
  4. Do you NOT have an implanted electronic device (like a pacemaker)?
Answer every question to see your result.

What does participation involve?

If you join this study, you will use the Compex SP8.0 device at home for up to four weeks to help manage your muscle or joint pain. A healthcare professional will show you how to use the device during your first visit to the clinic and provide you with a guide.

You will have a visit to the clinic at the start of the study (called the 'Baseline Visit'), then a check-up after two weeks, and a final visit at the end of the four weeks. During these visits, the study team will assess your pain level. In between visits, you will use an electronic diary to record your pain level before and after each time you use the device. The study will also ask you to complete questionnaires about how easy the device is to use and how satisfied you are with it. There are no medications involved in this study, only the use of the Compex SP8.0 device.

Potential risks and benefits

Participating in this study might offer the benefit of potentially reducing your muscle or joint pain through the use of the Compex SP8.0 device. You'll receive training on how to use the device for pain management. As with any medical device, there are potential risks, though these are typically minor with TENS-like devices. These could include skin irritation where the pads are placed, or in rare cases, discomfort from the electrical pulses. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Salford University Sports Injury Clinic
    Verified postcode
    Salford, United Kingdom
  • Worsley Physiotherapy and Sports Injuries Clinic
    Verified postcode
    Worsley, United Kingdom

Common questions

What is the Compex SP8.0 device?

It's a device that uses gentle electrical pulses, similar to TENS therapy, to help relieve muscle and joint pain.

How long will I need to use the device?

You will use the device at home for up to four weeks as part of the study.

Will I have to go to the clinic often?

You will have three visits to the clinic: one at the beginning, one after two weeks, and one at the end of the four-week study period.

What kind of pain is this study for?

This study is for adults experiencing ongoing muscle and joint pain, which can include pain from injuries or nerve-related pain.

Are there any side effects?

Possible, though usually mild, side effects could include skin irritation where the pads are placed.

How to find out more

Veronica Sebeo

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

Interested in taking part?

Register your interest

Share your details and the research team for "Compex SP8.0 - Symptomatic Treatment of Musculoskeletal Pain…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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