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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device
DeviceTranscutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device, using the following pain management program, • High Intensity TENS (50-150 Hz)
Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device
DeviceTranscutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device, using the following pain management program, • Low Intensity TENS (5 Hz)
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: High Frequency TENSExperimental treatment 1 intervention
Group B: Low frequency TENSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in pain level
Improvement in pain demonstrated by the score on the Numerical Pain Rating Scale (NPRS) at the beginning and the end of the treatment period when using the pain management treatment programs of the device. The Numerical Pain Rating scale (NRS)is a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". The overall success of the study as well as the evaluation of the primary endpoint will be based on the proportion of subjects who experience a ≥ 2-point decrease in pain scores at the end of the treatment period as compared to baseline.
Time frame
From enrollment to full recovery or end of treatment at week 4Secondary outcomes
1
Incidence of Treatment-Emergent Adverse Events
Adverse events/malfunctions/complications reported during the study. Subjects and Investigators will be prompted to record such issues on the AE evaluation form. The incidence of the observed events will be tabulated by category (as in No. of observed events / No. of patients in the safety population).
Time frame
From enrollment to full recovery or end of treatment at week 4Other outcomes
1
Device Usability and subject's satisfaction
Evaluation of device usability by the subjects and subjects' satisfaction on a 4-point Likert Scale. Subjects can choose the option that best corresponds with how they feel about the question,
Time frame
From enrollment to full recovery or end of treatment at week 42
Short term effects of the treatment on pain level
Evaluation of the immediate improvement of pain using the NPRS following each daily treatment. The Numerical Pain Rating scale (NRS)is a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". The efficacy data for this analysis will consist of data obtained from the patient diaries.
Time frame
From enrollment to full recovery or end of treatment at week 4 Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: