Compex SP8.0 - Symptomatic Treatment of Musculoskeletal Pain

Launched by DJO UK LTD · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the Compex SP8.0 device, which is designed to help manage musculoskeletal pain, like back or joint pain. The goal is to see how safe and effective this device is when used as directed. Participants will use the device's pain management programs at home for up to four weeks. These programs work by stimulating nerves to help reduce pain through different methods.

To be eligible for the study, participants should be adults (18 years or older) who are currently experiencing moderate to severe musculoskeletal pain, with a pain rating of 4 or higher. They should also be able to safely use the device at home. However, individuals who are pregnant, have certain medical conditions or implanted devices, or are participating in other clinical studies will not be allowed to join. If you participate, you can expect to learn more about managing your pain while contributing to research that could improve future pain relief technologies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult subjects currently experiencing musculoskeletal pain with a Numeric Pain Rating Scale (NPRS) score of 4 or more at baseline.
• • 2. Subjects are considered suitable to self-administer stimulation of motor nerves or stimulation of sensory nerves at home, based on the Investigator's judgement.
• • 3. Subjects are suitable to receive treatment using the Compex SP8.0 device Pain management programs (pre-set parameters) for up to 4 weeks, based on the Investigator's judgement.
• • 4. Subject, both male and female, ≥ 18 years of age at the time of consent
• • 5. Subject has reviewed the IEC-approved consent form, has properly consented per the protocol and has documented their consent to participate in the study by signing the Ethics-approved consent form.
• • 6. Subject does not meet any of the exclusion criteria
• Exclusion Criteria:
• • 1. Pregnancy
• • 2. Presence of Implanted electronic devices (e.g., pacemakers, defibrillators)
• • 3. Skin conditions that contraindicate TENS use (e.g., rashes, wounds in electrode placement areas).
• • 4. Known allergy to electrode materials.
• • 5. Current participation in another clinical study that could interfere with this study's outcomes.
• • 6. Subjects who are not able to read and understand the Instructions for Use, warnings, cautions and dangers
• • 7. Subjects who are not able to read and understand indications and contraindications of the device
• • 8. Subjects who are not able to sense auditory and visual signals
• • 9. Subjects who are being treated with any other electrotherapy device for pain relief.
• • 10. Subjects who are being treated with acupuncture
• • 11. Participation in another clinical study within 30 days prior to screening