Compex SP8.0 - Symptomatic Treatment of Musculoskeletal Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDJO UK Ltd
About this trial
This post-market clinical study of the SP8.0 Compex device aims to comprehensively assess the safety and performance of the device when used in accordance with the approved Instructions for Use. The results of this study will also support the clinical evaluation of the next-generation wireless product currently under development.
The Compex Consumer devices contain different programs, such as conditioning, fitness, recovery, massage, rehabilitation, and pain management.
This study will utilize the Compex SP 8.0 pain management programs, with the aim of assessing the effectiveness of the treatment provided by the device in managing pain through different physiological mechanisms.
Eligibility criteria
Qualifiers
Adult subjects currently experiencing musculoskeletal pain with a Numeric Pain Rating Scale (NPRS) score of 4 or more at baseline.
Subjects are considered suitable to self-administer stimulation of motor nerves or stimulation of sensory nerves at home, based on the Investigator's judgement.
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.
Subject, both male and female, ≥ 18 years of age at the time of consent
Disqualifiers
Pregnancy
Presence of Implanted electronic devices (e.g., pacemakers, defibrillators)
Skin conditions that contraindicate TENS use (e.g., rashes, wounds in electrode placement areas).
Known allergy to electrode materials.
Trial design
Treatments tested in this trial
- Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device
- Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device
Treatment groups
74 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov